LINK TO FULL TRANSCRIPT

TRANSCRIPT

Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an associate professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

There are known problems in enrolling a representative sample on cancer clinical trials, with stark disparities within certain demographic groups, including age, sex, and race and ethnicity. Patients who are female, non-White, and at the age extremes, either younger or older, are known to be less likely to participate. With skewed patient participation, the validity of randomized data may be questioned, with some asking whether clinical trial results based on a charmed enrollment sample can truly be applied in routine practice.

I'm happy to welcome two guests today to discuss new research highlighting how we are doing with diversity in key cancer clinical trials. Dr. Jennifer Miller, is Co-Director of the Program for Biomedical Ethics and an associate professor at Yale School of Medicine. Her research focuses on ethics, equity, and governance in research, development, and accessibility, as well as in the ethics of healthcare data sharing. She is the first author of the manuscript, "Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012 to 2021: Bright Spot Trials and Trends Over Time," which is featured in JCO OP's March print issue.

Megan-Claire Chase is a 10-year breast cancer survivor, patient advocate, and a current program director at SHARE Cancer Support, a national nonprofit that provides free education, assistance, and navigation services for people with breast and gynecological cancers. Since her treatment for stage 2A lobular cancer, she has worked to fill the gap of knowledge and advocacy for young patients with cancer, including through her blog, Life on the Cancer Train, and through the podcast, Our BC Life.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Jen and Megan-Claire, it's really nice to speak to you today.

Dr. Jennifer Miller: Thank you for having us.

Megan-Claire Chase: Thank you.

Dr. Fumiko Chino: Jen, before we dig into the specific research, do you mind giving us a little bit of background about your work in bioethics and what led you to start this specific work on clinical trial diversity?

Dr. Jennifer Miller: Yes, thank you so much. So, as you mentioned, I'm the Director of Bioethics for Yale School of Medicine and a professor of internal medicine at Yale. And then also in 2005, I co-founded a nonprofit called Bioethics International and direct a project called the Good Pharma Scorecard. In all of those roles, I'm focused on one big question: How can we help the 7 billion people around the world live a good life, a flourishing life? And in order to even talk about that bigger concept, we need to think about some basic things: access to clean water, housing, food, education, among other things, and a level of health.

And there are so many determinants of health, but one of them is access to medicines and vaccines. And when you think about access to medicines, you have to think about the role of the pharmaceutical industry, given that it sponsors 75 to 90% conservatively of the clinical research supporting FDA approval of our new medical products. What's interesting is while the industry has a very stated noble mission, right, to 'cure, heal, and advance people's health', when you survey Americans in particular, 91% think that companies put profits before people and patients, so money before people and patients. And when you look at the media and the court cases, they're covering mostly scandals and outright ethics failures ranging from concerns about whether companies are telling you the truth about the safety and efficacy of new medicines and vaccines and worries about outright price gouging.

And what's interesting is when I host a meeting every year with C-level executives from pharma, when I get them together and show them all of the concerns that stakeholders have about their patient centricity, I often hear the same two things: one, "Those are old issues that we fixed. If only you academics looked at more up-to-date data, you'd see that that is no longer a problem," right? And so they called the pricing problem a 'hoodie' problem because Martin Shkreli, he wore a hood, a black sweatshirt with a hood. But as we know, there's a widespread current and genuine pricing problem with medicines and vaccines.

And then they said it was an outlier company, right? "That's one company in an otherwise sound industry or rogue employee in an otherwise good company, not the industry as a whole." And so when I walked away it's, wow, there's a black box. We actually don't know the ethical or patient centricity performance of pharma companies, of an individual company, of a product, of a trial, or of the whole industry as a whole, and it's really important to know this.

And so, I got together a multi-stakeholder group and I said, "Hey, fine, I'm neutral. It's either a misperception, you're doing great and we need to build merited trust, or there really are some problems and we need to fix them and get them right for patients around the world." That's how I started the Good Pharma Scorecard, which is really designed to set ethics goals for the pharmaceutical industry and turn them into metrics so we can benchmark the performance of trials, products, and companies and then rate and rank them. What that does is it recognizes where there are good practices so we can study how they did it, but importantly to catalyze reform and change where needed for patients.

We started by looking at the transparency of clinical research, right: do pharma companies tell you all the safety and efficacy data about new medicines and vaccines? And we were able to measurably move the needle. In other words, pharma companies really changed their practices as a result of getting their Good Pharma Scorecard ratings and rankings. And so we turned our attention and said, "What else should we tackle?" And the next thing we tackled was representation in clinical trial enrollment, for exactly the problem that you mentioned. We tend to test our new medicines on healthy, young, White males that don't represent the patient population in the US or other countries who end up taking products post FDA approval.

Dr. Fumiko Chino: What a great narrative of how you kind of reached the point where you are doing this research. And again, I think you've highlighted that diversity in clinical trials is only one aspect of everything that could potentially be improved in healthcare in the United States. So I am so excited about what you're going to do next to address the next issue.

But let me ping over to Megan-Claire. I know a little bit about you personally, but can you share with our listeners a little bit about your background and just discussing for example, the multiple hats you wear in life? You have a cancer survivor, you're a cancer caregiver, you're a patient advocate, and obviously you work at SHARE. So what is your origin story for Warrior Megsie?

Megan-Claire Chase: Well, first of all, I always knew I would get cancer, and when people hear that, they're like, "Why would you say that? Like, why would you even, like, mention that out into existence," right? But it's no, like, I know my family medical history, at least mainly on my mother's side. And I'm an IVF result. It took my parents 8 years to even get pregnant, and then during the third month, my mother was diagnosed with ovarian cancer. And so, I like to say I'm literally a cancer because I was born in July. I was born 3 months early. I was supposed to be born the last week of October, and I was born July 3rd.

And so the joke in the family is, I look nothing like my mother externally, but internally, I got all the issues. And so we really are both walking miracles, the fact that we did both survive this, but I knew, I just knew I would get ovarian or cervical cancer because that's where all of my issues were. So I had been monitored since I was 16. And then, of course, having other health issues, being born premature and all of that, and then ultimately, I had very strange symptoms. We hear the guidelines of breast cancer, and I had none of those. But I also was an advocate. So in my family, my parents are divorced, so I'll mainly be talking about my mother's side. My maternal grandmother, my Nana, she was the first biracial registered nurse at St. Vincent's in Bridgeport, Connecticut. And my grandfather was a mortician, so we're like, "Boy, aren't they like the perfect couple, you know? She helped you in life, and he helped you in death."

But all of that to say, I was raised to know my patient right to change doctors, my patient right to ask questions, and my patient right to get pushy. And I did all the things. So we often hear, "Hey, you need to advocate for yourself." Well, even when you advocate for yourself, sometimes you're ignored because I'm a woman, then I'm a Black woman, and then I was under 40. So I wasn't even old enough to get a mammogram. And because there is that correlation between breast and ovarian, I was able to get one early and covered by insurance 100%, and they were like, "Hey, you're good. Come back when you're 40."

But I kept having all these other strange symptoms, and I just kept pushing and pushing for close to two and a half years, and then it wasn't until the cancer was like, "Okay, we're going to have to just make a grand entrance because no one's believing you." Then everyone sprung into action, and it was because of all that, and I thought to myself, "Oh my God, if I'm being ignored and I am someone who's pretty darn vocal, what if English wasn't my first language? What if I didn't know my family medical history?" Like, I just went down the rabbit hole, and my background is in media and marketing, and I'm also a writer. And so I was very open with my diagnosis because I'm an only child too. So this is like huge. It was just too big for me to deal with alone, but also I wanted to like amplify the barriers that I was experiencing and then also losing my fertility. I mean, it was just so many things at once, and it was through that, I ultimately realized, "Hmm, this cancer journey, it's never really over." And that was how I came up with the name "Life on the Cancer Train" because I was like, I keep waiting to get off the stop permanently, and that's not happening.

And though I am now in double digits of 'no evidence of disease', I call it my boyfriend NED. We've been in a long-term relationship now for 10 years and we're going to continue going strong. I've had so many other issues that no one prepared me for. And so I was doing a lot of advocacy work while I was in media and marketing, and then I was like, "Hmm, what would happen if I actually worked in this space? Like, imagine what I could do." And that's ultimately how I ended up finally working at SHARE Cancer Support remotely because I live in Atlanta, Georgia, so you may hear a slight twang every so often. And I am the Breast Cancer Program Director and host of Our BC Life podcast.

And, you know, through all of that, I am known in Cancerland as Warrior Megsie because my hair came back curly. And, you know, so many people are like, "Oh, I would have loved for my chemo to turn my hair curly," and I'm like, "Well, I wanted my hair." Every time I look at myself, it's traumatic. Yes, do I rock it? Sure. I mean, when it was coming in looking like a chia pet, I was a little concerned, but every day I'm reminded of what I've gone through and what I continue to go through. And that's ultimately how I made my grand entrance into Cancerland.

Dr. Fumiko Chino: Thank you for sharing that with us, and I know that this is not kind of how you wanted to find your mission in life, right? You would have been much happier to just live your previous existence without cancer, or just being a cancer caregiver, or just being an advocate, or just being a communicator and not being a cancer survivor on top of all of that. So, I do appreciate though that you took it for what it was, which is this is the path that you're walking down, and so let's try to make that path better for everyone, more comfortable, clearer, more outlined. And so I appreciate that.

Now, Jen, do you want to walk us through your actual JCO OP study, what you did, what you found, why it matters?

Dr. Jennifer Miller: Sure. Second plug for St. Vincent's in Bridgeport. My mom works there as well on Nine North, so I was so excited to hear that, that common touchpoint. So when we added the representation challenge to the Good Pharma Scorecard, we, obviously unsurprisingly, found abysmal representation of a variety of different groups or pretty much everyone. And we stepped back and we said, "What more can we do to measurably move the needle?" Because there have been 40-plus years of policy efforts to try to improve representation of women, older adults, and racial and ethnic minoritized patients among other groups, and we haven't measurably moved the needle for any group in cancer over the last 10 years.

And that's shocking not to see any improvement in 10 years. That's a lot of time and there's been a lot of investment on this issue. And so, what we settled on was this idea of doing a bright spot analysis. The bright spot approach assumes that somebody, somebody's getting it right, and if we could find that bright spot and study how they do it, we might be able to develop generalizable guidance for everyone else to be able to repeat that positive behavior. That bright spot analysis was done with the FDA Oncology Center for Excellence with their support. And so, while the 10-year data looked abysmal, right, we hadn't seen any improvements overall, when we started to look by sponsor, it turns out there were some bright spots. There were some sponsors who were able to consistently adequately represent one group. They couldn't represent everybody, but they were getting one group, right, and we decided to focus on Black or Latino identifying patients. And we found 33 bright spots.

So I'll tell you the overall data and then I'll talk a little bit about the bright spots. So we looked at a 10-year sample, novel oncology products approved by the FDA between 2012 and 2021, which was 111 novel cancer therapies sponsored by 70 different companies based on 121 pivotal trials enrolling over 50,000 patients around the world. And what we found was zero trials, zero trials adequately represented all the demographics we were looking at, which was sex, age, and racial and ethnic identity. And we were comparing enrolled participants to the patient population with each targeted indication.

However, 99% of trials were able to at least represent one group. 80% adequately represented women, 44% adequately represented older adults, age 65 and older. However, only 2% were able to adequately represent racial and ethnic minoritized patients. And we were only looking at a small group of race and ethnicities. So rather than focusing on the negative, we looked at those 33 bright spots and we said, "Let's go interview them. How did they do it?" And we heard some common practices that were now debating some processes that are likely to drive that outcome we're looking at that we're debating whether to add to the Good Pharma Scorecard. We'll add some, we're just trying to figure out which ones are most associated with success.

Dr. Fumiko Chino: I love this idea that you really wanted to go on a fact-finding mission, which is, "We know that things are bad. Let's document they're bad." But then for the few people, institutions, companies, whatever that are actually doing well, how do we learn lessons from them to then try to actually do a guide map for other places to run clinical trials in a more equitable fashion? If there's specific things that they're doing that actually helps them get more, for example, Black patients to enroll. So I love that, that you're like, "Let's go on a fact-finding mission, let's really, let's categorize it, let's share this knowledge so that we can then actually improve everyone - a rising tide floats all boats."

Now, Megan-Claire, are the findings that we just talked about - the 0% of trials were adequately represented for every different demographic - are they actually surprising to you? Because I still remember in 2022 when Stephanie Walker from the Metastatic Breast Cancer Alliance highlighted the 'ask gap', which is that Black women may be just as likely to enroll on clinical trials if they're actually asked, but they're just not asked. So I'd love your thoughts and how you see this kind of play out within the patient advocacy community, and then, you know, if we're really thinking about is this an ongoing problem reaching diversity of patients?

Megan-Claire Chase: Well, I was not surprised at all. And huge shout out to Stephanie Walker. Love her. She's amazing. I am someone who used to be totally against clinical trials. I was one of those that was like, "You're not going to use me as a guinea pig." And then I went through my own cancer experience, and my mother also now has a blood cancer, and watching her go through the clinical trial process also and I actually experienced medication not working in my body. And honestly, it was from that moment on where it really clicked for me. And I, you know, it makes me sad that I had to wait for myself to get sick in order to fully understand the importance of representation in clinical trials.

But it was in that moment where I was like, "Wait a minute, how many people were on the trial for this medication that looks like me? And I don't just mean like one or two." And then the fact that it kept happening over and over again, and I started thinking, "Oh my gosh, this is a really huge issue because if we're not represented, that means we don't know how those medications are going to work in our bodies." And the fact that I was intolerant of eight different medications that we kept trying and putting my body through, it was really eye opening for me. And then in my advocacy work, I've had a chance to look, at what is it called, the paperwork that you look at - the consent forms. I'm reading all of this terminology, and I'm like, "That's racist," or, "that's going to come across wrong to the community that you're trying to reach."

And so, after experiencing that, walking through it with my mother as well and then I was like, "We need to talk more about this." And so, I often hear over and over again, "Yeah, we're not getting enough representation in clinical trials, we're not being asked," but also we're not talking about it in a way that resonates. So like even the words "clinical trial" is problematic. And so, here's the way I started talking about clinical trials after my own experience is I think of it like dating, and I am trying to find the perfect trial. Now, was I ever offered a clinical trial or even told that could be a potential option? No. All of the information I found out was all on my own. And I was like bringing in research to my oncologist who at that time, my active treatment oncologist, I ultimately divorced her, and I said that to her face. I was like, "I divorce you because you're not listening to me. Thank you for getting me to this point, but now we're talking about medications are not working for me, and you're telling me, 'Oh, just get off it for two weeks and then get back on it.' And I'm like, 'I am not going to keep putting my body through this.'"

And so, I started thinking of it like, yeah, this is kind of like dating. You're trying to find the perfect trial. You're trying to help do something wonderful and healthy for your body. You're trying to improve your quality of life. But then when I was getting rejected from all these clinical trials because I'm not 'pristine', so to speak, I was like, "Okay, this is really hurtful." And I really like was taking it personally, and I thought to myself, "How many others stop at that first 'no' and they don't think, 'Hey, maybe I should try another one or maybe this one wasn't the right fit?'" So I started talking about it in a different way, and I think one of the big things that's missing is, right, the lack of trust with pharma. We're not really addressing that. Like, what are they doing to show they are trustworthy? Like we need it in like those kind of clear terms.

And then I'm seeing other great nonprofits like Touch, The Black Breast Cancer Alliance, what they're doing and trying to help educate the Black community about clinical trials. But it's also too, how do we talk about it with our elders in the community, right? And we have to first acknowledge the stain on our history. And when we have, you know, a lot of times they are White doctors, you know, maybe they are saying, "Hey, you might be eligible for a clinical trial," but are you actually like saying to the patient, "Hey, I acknowledge there's a huge stain on history when we think of Black bodies and Latino bodies as well. We acknowledge that. Let me tell you the changes that have been made. Did you know, like, if you're in an oncology clinical trial, you will not be getting a placebo. You will either be getting your standard of care treatment or the clinical trial medication." So many patients don't know that. And so, I really feel like there's a huge communication gap between providers and pharma and getting that kind of information to patients and talking about it in a way that resonates. So I was not surprised when Dr. Miller was going through her findings, but I'm also really appreciative of, okay, what is one thing that's going right and how can we build off of that? That's encouraging.

Dr. Fumiko Chino: No, I really appreciate that narrative for you. And again, it strikes back to me sort of knowledge I already know, which is immunotherapy might have worse side effects. It might be worse for women, for example, or an Oncotype score may be actually less prognostic for Black women. You know, we have some retrospective analysis showing these things because again, who was tested in these trials may not be representative of the people who are actually receiving these treatments.

Now, Jen, there was a recent qualitative analysis published in JCO OP called, "Why I Said No," and it evaluated why eligible patients with breast cancer declined clinical trial participation. They highlighted fear, mistrust, and also logistical challenges as key barriers. And you had mentioned previously that Bioethics International, your nonprofit that you helped found and lead, it seeks to, and I quote, "raise the bar on ethics, patient centricity, and social responsibility in healthcare." And of course, I see a lot of overlap in terms of what we need to improve. So outside of having better conversations and relationships with our patients like Megan-Claire outlined, how can the pharmaceutical companies have better standards to start addressing these concerns? You mentioned earlier just like at least one win that you had obtained.

Dr. Jennifer Miller: Yeah, and let me just go back to something Megan-Claire said. I found it really impactful. You said, you wanted to hear what pharma companies are doing to be trustworthy, and that's sort of the question behind the Good Pharma Scorecard. And what we do is we first engage patients to hear what do patients need to see from pharma companies, not just to trust them. You can trust a used car salesman who sells you a lemon, right? I am not interested in that. What do we need pharma companies to do so that we can advance our health, right, and yes, appropriately trust them? And so, we do a lot of dialogue with patients and also clinicians and other stakeholders, and that informs the development of our areas of focus and also the metrics that we build in.

And then Fumiko, I think you asked what success have we had with the scorecard in improving practices? Yes. So, we initially started with that concern that pharma companies are not telling us all the safety and efficacy about new medicines and vaccines. So we figured out how to measure that. So, for every product that the FDA approves, there's an approval package that the FDA releases. It's hundreds and hundreds of pages of PDFs. It's not machine readable, but if you were to be a crazy person and read all of those PDFs over and over again for every product that's approved, you could pick out all of the trials that are conducted and that the FDA reviews to decide whether to approve a product or not. There's a median of like 26 of them. You cannot use AI or any kind of natural language processing to pull out the trials because there's no pattern in the naming of the trials. It doesn't say in the FDA approval package, "Trial number XYZ." So we have a team, we manually go and read all those, and we pull out a denominator. We know all the trials that were conducted, and then we just go and see, we measure what proportion of them are registered in a registry like ClinicalTrials.gov run by the NIH. What proportion have reported results in that same registry? What proportion are published? What proportion are publicly available, meaning published or registered and reported?

The first study, it was such a low number that it was embarrassing. But I'm happy to say that at least for large companies, year after year, the score started going up. And then we created an amendment window where we said, "Here, companies, you have 30 to 60 days to improve things. We will publish a pre-score, but we will also publish a post-score." And half of the low scoring large companies took us up on the amendment window and improved things in data sharing. And so that is what emboldened us to start doing more. That's when we went to representation in clinical research, and then now we're looking at access to medicines in low-middle income countries. A new FDA approved product is tested in a median of 26 different countries if you're a large company, or 16 if you're all sized company. And generally speaking, the countries that participate in that research for FDA approvals never get market access to the products they helped test, and from an ethics perspective, that's considered exploitation. You go in, you use a population, and you don't give anything back. So now we've measured that extensively, so now we want to try to fix that.

Dr. Fumiko Chino: I love what you've done, and it really, I see a natural correlation with like for example, the Leapfrog Group who rate hospital quality and safety. And when you give a hospital an F and they're able to rate it, you know, to increase it to like an A score, it really shows that they're committed to the process. We can't improve anything unless we measure it. I know that sounds insane. Like, I'm sure every company that you had previously talked to for the pharmaceutical companies thought they were doing great, and then you were like, "Actually, not so great." And you have to highlight it, and then you have to give them something to do to improve their score. And so I, I really appreciate that it seems very no-brainer. So, thank you for your work on that.

Megan-Claire, our last formal question is to you, which is, there was this fantastic ASCO Education Book chapter from last year. It presented a practical guide to clinical trial accessibility, including a collaborative overview and highlighting that, quote, "a shared responsibility across sectors to modernize clinical trial design, to reduce access barriers, and to ensure that clinical trial participation becomes a standard and equitable component of cancer care - we all share responsibility in this." So in your mind, are there some low hanging fruit that we should work to start addressing first in our patient-facing interactions, or does kind of everything get equal weight in terms of what you think is important?

Megan-Claire Chase: Again, that communication, how do we talk about it? If you're going to tell me about a clinical trial, because a lot of times we're feeling the onus is on the patient, and we're like, we really need our providers to suggest, "Hey, why don't you look at this?" Or I feel like there needs to be like a middle person between the provider, have a middle person, and then the patient because a lot of that terminology we're hearing for the first time or we need a minute to even process. And then also, is this in Spanish? Is this in other languages? So we want to make sure that we're understanding it, and we really need some of that language not to be talked down to or anything like that, but just in a clear, simplified way. And also, where are the images? Like, I want to see the people who have been on these trials. And a lot of times we're getting materials where the faces don't look like ours.

Then I am someone who was diagnosed under 40, so I was getting materials of old White women and White men on there. And so it feels like, okay, you keep trying to say you're including us, but you're not really showing- we're not seeing those efforts like visually or on the page. And so, I understand that a lot of times when we're talking about clinical trials that it's the medical community and the researchers, they need to understand all of that. But why don't we have like a patient side where it's been like, "Hey, here's what they're saying in their scientific way. As a patient, here's what you need to know." And honestly, like, we need more voices like mine, quite frankly, that can bring in like the creativity to it because to me, again, that's what's missing.

And I also think too, again, if we can talk about it in a way where we're saying, "Look, we know it's problematic. We have to keep acknowledging the history," and that just never gets done. And so, you know, I want to actually bring up different ways to talk about clinical trials. So something that we do at SHARE Cancer Support, we actually have a novella, and this one in particular, I'm really proud of, helped to write and come up with the characters along with our Spanish speaking program. And it's about a Black woman and then a Latina woman and then an Afro-Latina, and they have triple negative breast cancer. One has metastatic, and we go into it in like, you know, with those cultural nuances and talking about, "Hey, this one, she decided to look into a clinical trial."

Well, also too, the other issue is access. Where are those clinical trial sites? Who's going to pay for daycare? And you're asking us to come during the daytime when a lot of us work. And if you're trying to really reach deep into the communities where maybe they are not white collar careers that they have and maybe they need to be close to a bus line, it feels so teeny tiny, so to speak, but they're major parts on the path to getting that representation in clinical trials. So I feel like we have a long way to go. Yeah, we can talk about it, but if we're not putting those little pieces to lead a nice pathway into the trial, then, then what are we doing? We just keep talking in circles.

Dr. Fumiko Chino: Yeah, no, I love it. You've actually outlined all of these different breadcrumbs that we could follow the trail to track clinical trial diversity that we're so far making, I would say, small to minimal efforts towards. And it's just some things that you mentioned that I wanted to highlight is that we already know that if you actually want to enroll a diverse sample, open the trial closer to that patient population where they live, where they receive cancer. Like we have at this point, pretty good research. You bring up the idea of like, we need something like a clinical trial ombudsman. I've been kind of shouting this idea out for a while for financial toxicity. We need a financial toxicity ombudsman, but it's- we need someone who's impartial who can communicate between providers who may have some bias, you know, they're trying to enroll on clinical trials. The thing that they're offering you may not actually be the best clinical trial for you. So we need kind of an impartial person to kind of interface. So 100%, I agree with all of that.

We are wrapping up the podcast. I want to leave just a little bit of extra time at the end if you think that there's something important that we didn't cover, if we want to talk about how the shift away from DEI is going to change the future of cancer research, or if that's just too depressing to talk about in the last couple of minutes of our conversation. I want to leave it open. Jen, anything from you in terms of wrapping up?

Dr. Jennifer Miller: I want to put a plus one on everything Megan said and her work as a trial navigator because in the bright spot analysis, when we went in and interviewed the bright spots, we came up with 14 shared factors that are associated with success, and one of them is navigators. The critical importance of navigators from symptom onset through diagnosis, through testing, through access to care and clinical trials. So just want to thank Megan for her work and amplify that in any way possible.

Dr. Fumiko Chino: Wonderful. And Megan-Claire, last thoughts from you because I think it's very fitting to leave it with a patient advocate for the last word.

Megan-Claire Chase: Well, thank you so much. It's only because of conversations like this and trying to reach different audiences that we are able to continue to have these conversations, but more importantly, have some action behind it, right? And so, I do think it's important to acknowledge, okay, we have made some great steps, but there's more. And quite frankly, the patient community and those in minoritized communities, we deserve more, and we just really need to make sure that we're trying different ways to communicate that clinical trials are safe and here's why you should consider one, and even if one is not right for you or even if you don't even need one, it's still important to know.

Dr. Fumiko Chino: Thank you so much for this great conversation today. Many thanks to Dr. Miller and Ms. Chase as well as our listeners. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.

I hope you'll join us next month for Put into Practice's next episode, and until then, I hope your winter is starting to thaw.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Jennifer Miller

Employment Company:

Company: YALE UNIVERSITY

Consulting or Advisory Role

Company: GalateaBio

Research Funding

Company: Bristol Meyers Squibb

Other Relationship

Company: Bioethics International

Company: CSL Bioethics Advisor

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I am Dr. Fumiko Chino, an associate professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

People with blood cancers may have prolonged clinical courses lasting years or decades and requiring specialty care. Prior research has shown that end-of-life care in this population may be suboptimal with higher hospitalization and lower hospice enrollment. Capacity for receiving appropriate specialty care has been a known concern with Medicare Advantage plans, but paradoxically, there may be unique advantages for those at the end of life. I am excited to welcome a guest today to discuss new research highlighting how insurance type may affect quality of end-of-life care for patients with blood cancer.

Dr. Hari Raman, MD, MBA, is a clinical fellow in hematology-oncology at Dana-Farber Cancer Institute. He got his MBA from Harvard Business School in 2023 while doing his internal medicine residency at Brigham and Women's. His research focuses on quality care delivery and value in healthcare with a focus on hematological malignancies. He is the first author of the manuscript, "End-of-Life Care for Older Adults With Blood Cancer With Medicare Advantage Versus Medicare Fee-for-Service Insurance," which was featured in JCO OP's February print issue.

Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the podcast today.

Hari, it is really wonderful to speak to you today.

Dr. Hari Raman: Thank you so much, and I really appreciate this opportunity to join you.

Dr. Fumiko Chino: I have been hosting this podcast for over a year, and I think you are actually our first guest who is still in their training. So, I love this, I am excited to have you here. Do you mind giving us an overview of kind of where you are in your career and what got you interested in this topic?

Dr. Hari Raman: Yeah, no, of course. And again, I am really grateful to be here in training. I knew I wanted to care for patients, but as I continued training, particularly in my residency, I came to realize how many considerations around care delivery and the administration of healthcare actually exerts a significant influence on the patient care itself. And so while I was in training, I was really fortunate enough to receive an MBA while in residency to gain kind of a foundational understanding of how the business and financing of healthcare in the US, particularly, impacts care delivery and access. And as a clinical fellow at Dana-Farber, I have just been incredibly grateful to join Dr. Oreofe Odejide's lab here at Dana-Farber. She is actually the senior author of this study, where we have been able to examine care delivery and outcomes research for patients with blood cancers. This is really the intersection of both my clinical and academic interests given that my clinical focus will be caring for patients with lymphomas.

Dr. Fumiko Chino: And you are at the tail end of your training, right? So, you are, you know, out the door, correct? Or maybe you are not out the door.

Dr. Hari Raman: No, exactly. You hit it right on the head. I will actually be staying on as faculty here at Dana-Farber next year, and I am really excited to continue our research and also be able to care for patients with lymphoma starting quite soon, actually.

Dr. Fumiko Chino: That is so exciting. So, within this calendar year, you will be setting up shop on your own.

Dr. Hari Raman: That is the plan.

Dr. Fumiko Chino: Wonderful. And it is amazing to have built this large group of collaborators again within the same hospital system and academic world where you did your MBA and your additional training, so that is phenomenal. Hopefully, you will continue working with the same people.

Dr. Hari Raman: Yeah, exactly. You are exactly right. It is really so inspiring and also really we are really quite lucky here to be able to go down the hall and ask experts in healthcare policy what they think about some of our findings and really be able to get a rich discussion even within the walls of our own institution. So, I have been really grateful for that.

Dr. Fumiko Chino: Now, before you discuss this specific new research, do you mind giving our listeners a little bit of an overview of what you see as the key differences between the traditional fee-for-service Medicare and Medicare Advantage? I know personally and, you know, I think within oncology we really commonly encounter problems with the MA plans. We have network restrictions, we have coverage limitations, we have obviously prior authorization burdens. But there is obviously a lot of advantages, otherwise, it would not have proliferated at such a rapid rate in sort of the modern era.

Dr. Hari Raman: So crucially, the payment model for Medicare has been what we call fee-for-service, where the government or the Centers for Medicare and Medicaid Services, in this case, pays providers a set amount per service that they provide to their Medicare patients. In Medicare Advantage plans, private plans are actually paid on a risk-adjusted basis by the government or CMS to assume the total cost of care for patients. Theoretically, this would allow the government to have a somewhat predictable cost of care given that they are paying these monthly or bimonthly payments on a risk-adjusted basis and then also incentivize private plans to essentially limit the overall cost of care through various levers that they may be able to pull. I think you alluded to a really good point that part of these levers include things like restrictions on networks as well as potentially allowing patients to only go to certain providers or have certain hospitals in network.

While this is something that we think about from a restriction perspective, the other part of this to note is that Medicare Advantage is a voluntary program that patients choose to go onto. As you can imagine, the way in which these payers are able to get patients to go onto their plans is through other offerings, such as lower premiums, more add-ons such as dental or vision insurance, including other things such as care coordination, which is really important for oncology patients, or even access to lifestyle things such as gyms and other services.

Dr. Fumiko Chino: Yeah, I know that at least based on my own prior research that the populations that have traditional Medicare and the populations that have Medicare Advantage really are a little different. Do you mind commenting on that?

Dr. Hari Raman: Yeah, and I think this also speaks to the offerings that Medicare Advantage plans often provide. What we have seen, particularly in the last decade, has been that Medicare Advantage plans tend to have enrollees that are more likely to be of a racial and ethnic minority group. Also, these patients tend to have lower incomes and are frequently dually eligible for Medicaid as well. I think this is both in part to the populations that Medicare Advantage payers are deciding to roll out to, but also in part because of the offerings that may be provided and may be disproportionately more attractive for patients who may have lower sociodemographic means.

Dr. Fumiko Chino: One thing that has always struck me with some of the literature and the research around Medicare versus Medicare Advantage is that Medicare Advantage offers more to patients when they are well, but it may be more challenging to use if you have serious and complex medical conditions, and ironically, it is actually more expensive to CMS than traditional Medicare. It is a little push-pull with the sort of the rapid proliferation of the program. There is more than 50 percent of enrollees are now in Medicare Advantage as opposed to traditional Medicare.

Now, do you mind walking us through your actual JCO OP study, what you did, what you found, why it matters?

Dr. Hari Raman: So, I think as you astutely pointed out early on the podcast, we know that for patients with blood cancers or hematologic malignancies, they really face significant challenges at the end of life. This is even in comparison to patients who have solid cancers. This primarily manifests as having increased rates of hospital admissions, ICU stays, and even dying in the hospital near the end of life. This really detracts from the ability for patients to be able to spend more time with their loved ones at home, which is something that they frequently voiced when folks have done studies examining patient preferences. Furthermore, we have seen that patients with blood cancers actually have decreased hospice utilization. We know that hospice, which is a multidisciplinary support service that is really tailored to offer maximal comfort and support and care for both patients and their caregivers at the end of life, is quite diminished in patients with blood cancers, particularly in comparison to whether it is patients with heart failure or solid cancers and any other really end-of-life illness.

And lastly, along the same piece of hospice, patients with blood cancers are also uniquely situated in a situation where they are required to have blood transfusions to support their quality of life, but also their blood counts. Oftentimes patients who are near the end of life require access to these transfusions, and the problem right now in our current models of hospice care is that hospice agencies are not equipped to provide access to palliative transfusions. This is primarily due to a mismatch in the financial reimbursement that they receive and the cost of providing access to transfusions. And so patients with blood cancers at the end of life are often forced to make really difficult tradeoffs between preserving access to blood transfusions versus enrolling onto hospice and then receiving all the benefits of hospice care that they may be able to receive once they enroll onto hospice.

Our question really was to understand whether there may be modifiable risk factors, such as insurance type, which I mentioned in Medicare is optional in terms of either enrolling onto Medicare Advantage or fee-for-service, and see if that may impact the quality of care patients at the end of life, particularly with those with blood cancers. We performed a retrospective analysis using data from the Centers for Medicare and Medicaid Services. Our data spanned about five years from 2016 to 2020, and we really focused on patients who had insurance coverage by either the traditional Medicare fee-for-service or Medicare Advantage plans. Patients had to have had coverage for at least 15 months in a continuous fashion prior to their passing. In terms of how did we assess quality of care at the end of life, we focused on administrative metrics that have previously been validated both in surveys as well as focus groups of both patients and providers. This really focused on three key aspects: hospice use, rates of high-intensity healthcare utilization, which is broken up into things such as emergency department visits, ICU stays, as well as rates of in-hospital death, as well as rates of advanced care planning to see whether patients and their providers have had these discussions about what is important to them at the end of life before they ended up dying. We had access to about 70,000 patients in our study, about two-thirds of whom had fee-for-service insurance and about a third of whom had Medicare Advantage.

When we thought about these individual metrics of quality of care at the end of life, we saw that about a little bit more than half of patients were enrolled in hospice across both cohorts. However, the Medicare Advantage patients tended to have higher odds of hospice enrollment with a nearly 11 percent increase in the odds of receiving hospice before they passed, as well as a decreased likelihood of having a very short hospice stay, which meant that patients who enrolled onto hospice with longer stays were able to more fully capture all the benefits of hospice. In terms of healthcare utilization, we also again saw that patients with Medicare Advantage plans were less likely to have two or more ED visits, less likely to have any ICU admissions in the last month of life, and had a nearly 25 percent reduction in the odds of dying in the hospital compared to those patients who were enrolled onto fee-for-service plans. In general, we found that overall that patients with Medicare Advantage seemed to have at least met administrative metrics for higher quality of end-of-life care compared to those with fee-for-service insurance across patients with blood cancers.

Dr. Fumiko Chino: One thing I think that was really compelling about your research was that it actually showed a sort of flattening out of what are very large gaps in health equity in terms of different patient populations that may be more likely to die in the hospital, be more likely to receive aggressive care, and it did not seem that you were able to find a difference, which is, I think, good. Do you mind speaking more about that?

Dr. Hari Raman: Yeah, exactly. To your point, we know that prior research has shown that patients who are particularly of racial and ethnic minority backgrounds tend to have higher rates of high-intensity healthcare utilization at the end of life and decreased hospice. As you mentioned earlier, similar to what we have seen in the national cohort, our Medicare Advantage cohort was also more likely to be from a racial and ethnic minority background. And so we then asked the question, well, do we see any differential changes in the benefits of Medicare Advantage, particularly at the end of life, across different racial and ethnic groups? We found that across our entire study, patients who were white versus patients who were non-white were equally as likely to receive benefits with regards to the kind of differential impact of Medicare Advantage versus fee-for-service, which I think was really interesting for us because we know that these patient populations are at very high risk for poor quality end-of-life care.

Dr. Fumiko Chino: Now, your findings are really consistent with some other research that I have seen that shows that Medicare Advantage may really improve some metrics of end-of-life care, and I think this is mostly likely due in part at least to the hospice carve-out for MA plans where Medicare steps in to actually cover hospice payments and that kind of makes it free for MA plans to deliver. I would love your thoughts on this and please correct me if I am misunderstanding this situation.

Dr. Hari Raman: I think you are exactly right, and I think this is a really interesting example of how policy can actually drive behavior. You see that as you mentioned, there is a financial incentive for Medicare Advantage plans to have patients enroll onto hospice. Just briefly to review, once patients enroll onto hospice, these Medicare Advantage plans are no longer responsible for the cost of care associated with that terminal diagnosis, and they stop receiving the risk-adjusted payments from CMS. However, they still receive rebates from CMS for the minimal amount of care not related to the terminal diagnosis. A study actually that came out of Brown earlier this year found that CMS may be spending up to 50 million dollars a year in extra payments to these Medicare plans after patients enroll onto hospice. I think the flip side really is that, you know, there is also a theoretical benefit for patients if we think that we are increasing access and enrollment to this valuable service. But I think it is very important to not ignore the fact that this is definitely incentivized from a financial perspective for Medicare Advantage plans to have patients enroll onto hospice.

Dr. Fumiko Chino: There is one thing you mentioned in your manuscript that I actually thought was really great in that, in thinking about how the money monies, because MA plans, they have that financial incentive to enroll people in hospice, they actually invest more into things like coordination of services and navigation. Do you mind speaking a little bit about that?

Dr. Hari Raman: Yeah, of course. And I think this kind of came out of the question that we had when we were discussing and we said, when we are in the clinic, we do not necessarily know what insurance a patient has and we do not really use that to drive a lot of our decision making. And so we thought, how are we seeing these differences? I think one thing that came up was that, you know, there is a lot of communications and interactions that patients have outside of the clinic with their payers and with other ancillary service providers. I think one key piece is that with Medicare fee-for-service, patients are not given additional services by default, and there is no real exposure to other services unless patients ask for it. However, in these Medicare Advantage plans, when you have things like care coordination and navigation, patients may be having these discussions with other providers where either things such as hospice enrollment or end-of-life care planning are reinforced and these ideas are kind of explored further at home. I think partly what we are seeing is that while we may not see a difference in the provider behavior whether patients have Medicare Advantage or fee-for-service, there may be exposures to things like care coordination that are driving a lot of these patient and caregiver behaviors in terms of thinking about when to enroll onto hospice or when we think about focusing more on the quality of life rather than extending life through hospital visits and ED admissions.

Dr. Fumiko Chino: There was a recent JCO OP analysis looking at switching from MA to traditional Medicare after a new cancer diagnosis because switching can be challenging if patients did not actually sign up for a gap plan at their initial enrollment, i.e., some people actually end up being trapped in an inadequate MA plan for their cancer needs and that has been unfortunately well-covered in the media at this point. There is a very limited number of states that actually have Medigap consumer protections. So the study that just recently came out found that people are more likely to switch if they live in these states. And so kind of in my mind, that means that clearly MA plans are not just wine and roses at the end of life; some people really do have a lot of problems with them for their cancer diagnosis. So I am not actually sure if there is a clear answer to the friend or foe question, but I wanted to ask you what the kind of nuances that you pulled out of this, you know, doing this type of work.

Dr. Hari Raman: Yeah, I think you are exactly right. I think it is, it is hard to know if there is a clear answer to the friend or foe question. But I do think what is really helpful here is that our analysis at least somewhat adds to the broad body literature that demonstrates that there are certain policy levers that we may be able to isolate from different alternative payment models such as Medicare Advantage or other new innovations that may be playing a significant role in impacting the quality of care that patients receive at the end of life. But I do think the important part you mentioned is something that our study was not structured to examine, was that we did not look at the quality or access to care for these patients prior to the end of life. And so we really focused on that last year period. And I think a key question here and a key concern for a lot of us is that we really need to ensure that patients have access to high-quality care across their entire cancer treatment journey from the diagnosis and ultimately to their end of life. I think our study here was focused at the end of life, but we really need more information as to the restrictions that patients may have when they get a diagnosis or when they start seeking treatment because these are all things that patients are concerned about and may not necessarily be focused on at the end of life.

Dr. Fumiko Chino: It is ironic because I thought about after reading your piece that we know historically it is hard to switch from MA to traditional Medicare, but if traditional Medicare has better access concerns for active treatment and Medicare Advantage has better end-of-life metrics, maybe, you know, we should be advising people have traditional Medicare for their treatment and then switch over to Medicare Advantage for their end-of-life needs, which seems insane, but weirdly could help, question mark?

Dr. Hari Raman: I think that is something that you bring up is a really good point. And I think, you know, the one thing I would say particularly in patients with blood cancers is that their disease trajectories are often quite unpredictable. And I think to your point, you know, it would be really nice if say we have these modifiable factors where we can things like switching insurance can allow us to either get more access at the beginning and then towards the end have different forms of insurance that give us more access to palliative care services. But I think the key nuance here is that patients and their providers may not know when that end-of-life phase occurs.

And so one thing that we are thinking about is, well, how can we incorporate some of these policy levers that are more pervasive throughout all insurance forms so that patients are not necessarily having to take that upon themselves while they are sick to think about insurance coverage? Because I think as I can attest for my patients, the last thing patients want to think about is insurance coverage when they are facing things such as a terminal diagnosis or even advanced cancer. And so I think you bring up a really interesting point and it often almost seems like the burden is on the patients to figure out a workaround while there may be an opportunity for us to think about implementing new policies to kind of ease that burden for patients.

Dr. Fumiko Chino: Very well said. We are at the tail end of our conversation, but I want to leave a little bit of space if there is anything that you feel like we did not address. I know for example that you also evaluated advanced care planning conversations and I was kind of sad to see that they were not had that often or at least not documented as being had.

Dr. Hari Raman: Yeah, I think it is kind of a quirk of the data a little bit. And so we used claims-based data and I think what we saw was that patients who enrolled onto hospice may not have had an advanced care planning documented. And so it did not really make sense to us right away. And I think part of this is due to the capitated structure of Medicare Advantage where providers are not getting reimbursed for having additional claims for advanced care planning and things like that. And so I think it is safe to assume that if patients were thinking about enrolling onto hospice they would have had some form of advanced care planning discussion. And I do think from a fee-for-service perspective this speaks to potentially the incomplete penetration of some of these billing codes that were initially designed to capture quality of care and quality of discussions at the end of life but may not necessarily be as disseminated throughout all these practices.

And so I am not entirely sure that the low rates of advanced care planning that we saw in our claims analysis necessarily reflects actual treatment patterns because it may just be that the providers are not enrolling onto these relatively new billing codes or billing for these new codes. But I do think it is a good point that you are making and I think one piece is that we do really need to capture that information through other means if possible, things such as large language models as well as NLP processing is starting to come out of there where they are looking at the actual notes that providers write for patients and we are starting to see some of these conversations really be able to be measured and calculated in a more accurate way.

Dr. Fumiko Chino: Yeah, that is such a good summary of it, which is that if I am not going to get paid more for documenting the conversation or specifically filing a claim for it, why would I do that? Because it is just extra paperwork on my part.

So, do you have a next step in terms of where you want to go? I mean you are going to start your faculty career within this year. Do you know what your first project is going to be?

Dr. Hari Raman: Yes, we shared some of our work at ASH earlier this year, but we examined-  we tried to take a similar approach looking at insurance coverage to try to focus on a younger population. So we did an analysis on patients aged 18 to 64, and the really neat thing in that population is there is kind of a natural experimental cohort because the majority of patients are either covered under Medicaid or commercial insurance plans. And we tried to ask some similar questions asking, you know, are there differences that we see in the quality of end-of-life care that patients receive with regards to Medicaid and commercial insurance? I think this is particularly relevant in this current time because of upcoming federal legislation looking at limiting access to Medicaid. And we actually found that, similar to what we have had here, patients under Medicaid were actually more likely to have higher quality end-of-life care compared to those with commercial insurance.

And I think again, a lot of this could be driven by many factors, but one key piece is that most of Medicaid around the country nearly 70 percent is actually in a managed care fashion and it is contracted through accountable care organizations. And so again we are seeing that some of these policy levers may actually be driving a lot of behaviors on both patient and providers particularly at the end of life in this very vulnerable population.

Dr. Fumiko Chino: I am excited to read more about that work, maybe even in the pages of OP.

Dr. Hari Raman: We are looking forward to working on that, thank you.

Dr. Fumiko Chino: Thank you so much for this great conversation today. Many thanks to Dr. Hari Raman as well as our listeners. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.

I hope you will join us next month for Put into Practice's next episode. And until then, please stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Hari Raman

No Relationships to Disclose

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Associate Professor in Radiation Oncology at MD Anderson Cancer Center, with a research focus on access, affordability, and equity.

Rural oncology care has many challenges, including travel distance, limited specialty care, sparse clinical trial infrastructure, and financial barriers leading to worse outcomes and access for patients from diagnosis through survivorship care. Oncologists practicing in rural areas often have difficulties coordinating care with geographically distant providers and limited availability. This is made worse by known workforce gaps.

I'm happy to welcome two guests today to discuss new research highlighting how specialist scarcity is felt by oncologists practicing in rural environments. Dr. Erika Moen, MS, PhD, is an Assistant Professor of Biomedical Data Science at Dartmouth. She is a health services researcher and leads a multidisciplinary team working to leverage network analysis to optimize cancer care delivery and patient outcomes. The long-term goal of Dr. Moen's lab is to improve equitable access to coordinated cancer care with a particular focus on rural populations. She is the first author of the manuscript, "Rural Oncologists' Perceptions of Specialty Scarcity and Repercussions for Care Delivery: A Qualitative Study," which was featured in JCO OP's first issue of 2026.

Dr. Dan Zuckerman, MD, FASCO, is the director of GI oncology and staff medical oncologist at St. Luke's Cancer Institute in Boise, Idaho. The center encompasses eight locations and is the region's largest provider of cancer care, treating a catchment area of over 20 counties. He is past president of the Idaho Society of Clinical Oncology and has been active in ASCO, including past chair of the Clinical Practice and Innovation Committee.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Erika and Dan, it's really wonderful to speak to you today.

Dr. Erika Moen: Hi, Fumiko and Dan. It's great to meet you both, and I'm looking forward to this discussion.

Dr. Dan Zuckerman: Me as well. Thanks, Fumiko. Nice to meet you, Erika.

Dr. Fumiko Chino: Erika, do you mind starting us off on how you got interested on how to try to optimize multidisciplinary care and why your focus is specifically in rural populations?

Dr. Erika Moen: Yes, absolutely. When I was a new assistant professor, I knew I wanted to focus my research program on bringing together my methods expertise in patient-sharing network analysis, which involves using healthcare administrative data to identify networks of physicians who share the same patients, with my research interest in cancer care delivery.

I remember reading an oncology workforce report published by JCO OP, and in that paper, there was a map visualizing county-level metrics of the number of oncologists per capita. And one of the things that immediately struck me was what I was seeing in rural areas. There would often be one county that had a relatively high density of oncologists, and it would be surrounded by counties with none. I wondered what the multidisciplinary referral networks of those physicians looked like and how physician departures or retirements would impact those patients and care teams. And because rural areas have known workforce shortages, and the delivery of high-quality cancer care depends on relationships between multidisciplinary specialists, these networks of physicians seemed critical to study and to support to maintain access to care for rural communities.

Dr. Fumiko Chino: What a great summary about how you got interested in this and trying to marry the data science of it all with the actual care delivery, like what matters to patients on the ground, which is: "Am I going to be able to see a specialist focused on melanoma or am I just going to have to see a general oncologist?" So that's a phenomenal narrowing in on "this is the reason why I'm doing the research that I want to do."

Now, Dan, congratulations on your recent nomination for the ASCO Board of Directors. I know that you have been passionate about improving quality care delivery for decades. Can you speak to your efforts in your home state and within ASCO to ensure that the science and technology and practice pattern advancements that we see at academic centers actually make it into the community?

Dr. Dan Zuckerman: Yeah, I think about the 44 counties in Idaho, and I'd have to guess that most of us are concentrated in three or four of those. But you know, a great example: so I've been practicing out here for 18 years, when I left fellowship, we came to a center where we had autologous stem-cell transplant but not allo. And so you sort of ask about one of the greatest innovations recently in oncology has been CAR T-cell therapy. And we were thinking about and watching our patients with leukemias and lymphomas being sent to places like Seattle or Salt Lake and thinking about, as Idaho grew and our population, urban and rural, how could we provide for that?

And so, really back in 2015, when I was director of our Cancer Institute, we got buy-in from our leadership, thankfully, to start building an allogeneic stem-cell transplant program with an eye to do allo, but also with an eye to know that we needed sort of that expertise in cellular therapies, all the way from lab to processing, to having the physicians and APPs and pharmacists to do that, so that we could deliver CAR T-cell within Idaho. And it took three years to build an allo program, and then we had planned to deliver CAR T-cell in 2020 and the pandemic happened. That delayed us by a year or two. But, you know, it's an example we're proud of, but it took a massive lift. I think originally it was close to a two-million-dollar pro forma with 19 FTEs, and we were fortunate to have leadership at St. Luke's and also a group of physicians who were willing to make that lift because we're not an academic center. But that's sort of one example where we've been successful in being able to bring some subspecialty care to a rural area, but it is incredibly difficult. And we still have gaps. So obviously I'm highlighting a place where we've been successful.

Dr. Fumiko Chino: No, I love that you mentioned CAR T-cell because I know we did a recent podcast episode about access to CAR T and how providing CAR T within the community is obviously the next step, and yet it's so challenging. There's these logistic challenges, but you also have to have actual buy-in from the institutions to build the programs because they will not build themselves. And I think: Oh, you don't have CAR T-cell in your community within your county, within 10 counties? You didn't even have it within your state! And so, that's a phenomenal effort, and it required so much investments in people and dollars and just time. So, I completely respect that.

And it dovetails really nicely into the next question to Erika, which is: the manuscript on deck that we're talking about really talks about the access to specialty care and how that can be very challenging in rural areas. Do you mind giving us an overview of the manuscript, kind of what you did, what you found, what you're excited about in terms of the next steps?

Dr. Erika Moen: Sure. So, our study conducted and analyzed qualitative interviews from 20 oncology physicians across five sites that served a rural catchment area. And it was part of a larger project evaluating patient-sharing networks for cancer care. And we identified three major themes. The first was participant experiences related to the effects of physician shortages on care team expertise, collaborative relationships, and patient volume. The second related to the strategies that oncologists use when facing physician shortages, including referrals to outside health systems or generalists practicing outside their subspecialization, and reallocating time from other responsibilities. The third theme described the unintended consequences of these adaptive strategies, including greater patient travel burden, less optimal or delayed treatment, reduced access to clinical trials, and increased physician burnout and lower job satisfaction.

We then developed a conceptual map showing the connections between these themes in the broader context of an oncology physician's departure. And I think I'm really excited about the effort to map some of these themes together because I think it can be informative depending on the adaptive strategies that are being used to try to manage a workforce shortage; different interventions might be more or less effective to ensure that the care teams and the patients are supported.

Dr. Fumiko Chino: It's really interesting. It reminds me of, you know, I grew up in Indiana, and not a tiny town, but a small-town Indiana. My mom was practicing oncologist, and her referral patterns, so, for example, when she retired, her referring physicians had to figure out, "Well, who do we trust now? Who are we going to reroute our consults to now that you are no longer in service?" As it turns out, as someone who started a practice and then actually ultimately hired my sister, it was a very easy dovetail.

Dr. Erika Moen: No, but I think that's exactly right. And the importance of trust really came through as a prominent challenge that was faced by physicians that did have someone depart. And I think it's just a human experience we can all relate to.

Dr. Fumiko Chino: So Dan, I'll ping it right over to you because I would really love your thoughts about how the themes outlined in this study is something that you may find in your practice. So, for example, I know that you work at a large center, but with many referral in the community. For example, in GI oncology, I could imagine if someone retired who was a gastroenterologist in the community, that you would have this whole cascade of potential difficulties for you. Do you mind speaking about that?

Dr. Dan Zuckerman: Yeah, no, for sure, Fumiko. And on a personal note, it's funny that we both have parents who are oncologists. So I, unlike your sister, I'm actually practicing with my dad here and he's imminently retiring. And what you mentioned about that legacy and that expertise and that trust in the community and what that means and who he'll hand his practice off to certainly resonates.

But certainly talking about subspecialty care, and I think, you know, Erika and her group's paper really honed in on a key linchpin physician is often the surgeon. And so I do mostly GI medical oncology and for us, you know, we had two HPB surgeons for, you know, sort of the middle part of my career. And then the senior surgeon, who we had poached from Seattle and was, you know, sort of towards the tail end of his career, retired. But he was doing quite a bit of volume, but also was the sort of respected physician, was sort of the leader for that. And that definitely for at least a year or two was a challenge for us in terms of replacing his expertise, of putting more volume on his junior physician.

Probably more pointedly, and I think Erika's paper points this out, is that we for a long time had a urologic oncologist who was just the key person for our GU program, was doing all the RPLNDs, the cystectomies. He was just 55, had a background in the military, and realized that he could go to the local VA and dial down for quality-of-life purposes because he was exhausted, because he was that key physician. So, he was seeing so many patients, he was the heart of the program, and then all of a sudden he left. And right in the midst of it now, we're scramble- literally scrambling in terms of are we sending these patients down to University of Utah, which is sort of our closest partner academic center? Is it the community urologist, who you know, haven't done that many cystectomies in a while and haven't done an RPLND in a decade, that we rely on?

And so, yeah, we definitely feel it as a concrete example in our GU oncology program with just the departure of one physician has caused quite a bit of scrambling and quite a bit of changes in practice patterns. You know, Erika's paper also mentions possibly suboptimal care, so our patients not doing the standard neoadjuvant immunotherapy-chemotherapy with followed by cystectomy; are we doing more bladder preservation simply because we just don't have a surgeon to do it and patients don't want to travel? And so, the downstream impacts from the loss of expertise when you already have a scarce physician population are deeply felt every day.

Dr. Fumiko Chino: Erika, one thing that really struck me from your work is that there was real difficulty, it seemed like, recruiting a truly rural sample provider. So, for example, all of the physicians in the study were at centers who had large rural catchment areas, but almost all of them worked at NCI-designated cancer centers. And I do typically think of those as being pretty well-resourced. So, it's very different than, for example, again my mom's community practice, where she was at one point the only radiation oncologist. So, I would love to hear from you about that perspective of sometimes even getting the voices of the people you want to hear from, how challenging that is.

Dr. Erika Moen: Yeah, I agree completely. I'll start off by giving a big thanks to the physicians who did participate in our study, and perhaps some of them are listening. We did have more success recruiting when we were able to leverage a personal connection or a local champion, and these were often at other NCI cancer centers. We did try to recruit at outreach or community sites within those larger health systems and we had some success there. But I think it's going to be really important to understand which of our findings can generalize to community-based practices that aren't part of a larger integrated health system and identify the challenges that are more unique to care delivered outside of the context of a large health system. So yeah, I mean our sample is what it is, and I think some of the challenges will be universal but probably even greater or amplified in the places with fewer resources.

Dr. Fumiko Chino: And I'll just say even for, for example, my mom's practice, which she, you know, was an independent practice, since she retired it has now been part of this sort of large conglomerate oncology practice. That may be also just how the wind is blowing in America in terms of consolidated care.

Now Dan, there was a recent JCO OP analysis that was about the use of telemedicine oncology, and it highlighted that even after the telehealth boom of the pandemic, rural patients were still less likely to use telemedicine. They continued to have, for example, higher utilization of emergency services. And I'd really love your perspective on this. I know that you had recently helped transition your benign hem program to be an e-consult-based workflow. So I assume you're pretty familiar with some of the access issues that rural patients face.

Dr. Dan Zuckerman: Yeah, that's a great point, Fumiko. And I think there's sort of two parts to that. The telemedicine piece is interesting. On face value, I think- I and I think my colleagues had assumed that rural patients, especially because of travel distance, really just, you know, time in the car and gas money, that there might be a higher uptake. And I actually was surprised to see that it's not as high. And I think the reasons for that are manifold, but you know, some of them are technological, just is simply that patients don't have adequate Wi-Fi access or maybe predisposed also I think culturally to not want to engage with the technology. Rural populations often tend to be a little bit older and patients who just prefer, you know, to give me that line and say, "Hey, I'm sort of old-school, I just want... I'd actually rather spend three hours in the car and drive down to see you than log on," because of that experience.

That's an interesting point that we've definitely seen even in Idaho, that there has not been widespread uptake. You know, that said, there are some patients who do fine with the technology and prefer the convenience, but it's not as penetrant as I thought it might be.

In terms of the e-consultation, that's been a great way for us to be able to handle classical hematology, which, you know, probably comprises 20, 30 percent of all our volume, simply to make room and improve access for patients. And that's sort of been a win all around in the sense that we've been able, you know, getting questions about, you know, macro-cytosis in people with alcohol history or somebody who has a thrombocytosis and the PCP didn't appreciate that they'd had a splenectomy. I mean, you know, sort of stuff that I think we would might label garbage or just not even rising to the point of requiring even a hematology, we can handle on the back end. And that way the primary care provider, they get an answer quicker, the patients don't have to get in the car. I mean, that's super frustrating when you see a patient and they've driven three hours to see you and then you're sort of trying to not exactly cover for the PCP, but just make it clear this is just a nothing burger. I'm sorry you had to come here and spend all this time and money and find someone to watch your kids and then get a bill from my health system because it's a, you know, billable encounter.

So, from the e-consultation perspective, actually the biggest barrier, I'll just tell you Fumiko, as you can imagine, is we weren't interested in doing work for free. And so, the biggest barrier was really just: how do you get credit to the physicians? And so, finally - it's not that complicated but finally someone agreed on the back end to have a dummy RVU. So, that's the system we use. A note goes into Epic, the provider can read it, the patient can see it, they don't have... the patient doesn't have to do anything, and they don't get a bill, but the physician who took, you know, four to seven minutes to review something pretty easily gets a quote dummy RVU credit. And I don't know if I'm embarrassed or just honest to admit that that was actually the sort of final barrier to getting that program up and running. And it's worked well to improve access.

Dr. Fumiko Chino: That's such an interesting workaround that you've created within your health system, and I think it really actually is very telling, which is when we think about how to truly generate better integrated care, less wasteful care, truly important, like meeting of the minds of this specialist for this specialty problem, reimbursement is so important. Trying to figure out how do we get things paid for - it's actually one of the major concerns about, for example, the current environment in which reimbursement for even telemedicine might go away, which could create huge access problems in rural populations.

Dr. Dan Zuckerman: You mention that, Fumiko, and I don't think we're alone, but unfortunately, you know, I think it had to do with something with the government shut-down and lack of funding, but that we, I think we're not alone as a health system that put a moratorium on allowing for telemedicine visits, simply because they weren't being reimbursed. And patients were scratching their head because, like, a week before they could do it and the week after they couldn't. And yeah, that's been a terrible thing for access for those patients who do want to take advantage of telemedicine.

Dr. Fumiko Chino: We're kind of at the tail end of the podcast. I want to leave a little bit of space at the end to talk about any issues that you feel like we haven't covered. We've talked a lot about the potential problems related to providing specialty care in the rural environment, but we haven't really talked about any solutions. You know, I'd love to hear any thoughts as we walk out the door in terms of thinking about - I know, for example, in the paper, Erika, you mentioned something like a community-based virtual tumor board, and I certainly can think about that as being really nice to bring a community together to actually talk about difficult cases and actually so for people to actually meet each other and to become familiar with each other and to start trusting each other. I can imagine that's actually a very compelling solution.

Dr. Erika Moen: That would be a good solution for the issues around losing someone you trust and someone who you are familiar with in terms of the way that they think about cases or the way they think about their workflow. And so I thought that could be a way to manage that, but it's not going to solve all the problems. So that's why I do think solutions have to be multi-level and multi-faceted, whether there can be navigation when you're now spanning two health systems that don't share electronic medical records. Can there be some proactive work there? But I think sometimes it does come more as a shock to the system, in which case maybe, you know, you're in a reactive mode, and then it gets to be harder in terms of managing those challenges in real time.

Dr. Fumiko Chino: Any last thoughts from you, Dan?

Dr. Dan Zuckerman: Well, I'd just like to say, you know, reading Erika's paper and thinking about rural- you know, oncology in rural America, I appreciate that it captured some of the qualitative aspects of the fact that your group interviewed oncologists in rural areas, taking care of rural patients, that a lot of it was the loss of expertise and camaraderie and trust that can be leading to burnout as much as volume issues, which I tend to agree with. Yeah, I mean, it sucks when you lose a partner and you have to increase your volume and your workload and you're seeing 24 instead of 20. But, like one of your participants had said, it's just like you can sort of just turn up the dial or order... get another APP, and yes, we all know how to work harder. And that does contribute to burnout, but it may not be as appreciated how much we still value, as oncologists, caring about our colleagues and the expertise and the lack of penetrance of expertise into rural areas. And so, I thought that was a useful point that one of your participants said: "Okay, we have more volume, but I'm exhausted, but I survive." And I often feel that way, and I'm sure, Fumiko, even in academic center, we all feel that way, but getting the expertise and getting distribution of expertise into rural areas is really, really difficult and is an ongoing challenge. And I think your paper highlighted that well.

Dr. Fumiko Chino: Absolutely, you really have to have a passion for the work, and that is what carries you through.

So, on that note, I want to thank you so much for this great conversation today. Many thanks to both Dr. Moen and Dr. Zuckerman for your time as well as for our listeners' time.

You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the "JCO OP" Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode. Until then, I hope your 2026 is off to a wonderful start.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures

Dan Zuckerman

Leadership

Company: OncoHealth Medical Group, PA

Consulting or Advisory Role

Company: Oncology Analytics

Company: AstraZeneca

Company: Revolution Medicines

Erika Moen

No Relationships to Disclose

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Dr. Chino talks with Dr. Talya Salz, the first author of the JCO OP manuscript "Impact of an Electronic Patient-Reported Outcome–Informed Clinical Decision Support Tool on Clinical Discussions With Head and Neck Cancer Survivors: Findings From the HN-STAR Randomized Controlled Trial (WF-1805CD)" which was published earlier this year simultaneous to the ASCO Quality Care Symposium. Jeff White, the Director of PR and Strategic Communications for the American Society for Radiation Oncology, also joins the conversation to provide the patient advocate perspective.

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Associate Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Incidence of head and neck cancers is rising, primarily driven by HPV-positive oropharynx cancers, which are commonly diagnosed in younger people with overall excellent disease outcomes. Patient-centered cancer survivorship is a key evolving area of study, with the goal of improving quality of life after cancer treatment. This is particularly important for people in head and neck survivorship given large post-treatment symptom burden, including speech and swallowing problems, dry mouth and dental concerns, neck fibrosis, and pain.

I'm happy to welcome two guests today to discuss new research on how to improve communication in cancer survivorship. Dr. Talya Salz, PhD, is an Associated Attending Outcomes Research Scientist at Memorial Sloan Kettering. Her research aims to improve the quality of life for cancer survivors, focusing primarily on late effects after cancer treatment. She is the first author of the JCO OP manuscript "Impact of an Electronic Patient-Reported Outcome-Informed Clinical Decision Support Tool on Clinical Discussions With Head and Neck Cancer Survivors: Findings From the HN-STAR Randomized Control Trial." This publication was simultaneously presented with the 2025 ASCO Quality Care Symposium.

Mr. Jeff White is the Director of PR and Strategic Communications for ASTRO, the American Society for Radiation Oncology. He focuses on media outreach and manages ASTRO's social media channels in a way to expand knowledge and awareness about radiation oncology and its critical role in curing cancer. He was diagnosed and treated for an HPV-positive tonsillar cancer in 2023 and shared his story on RT Answers to help other patients understand the role of radiation, surgery, and chemotherapy in head and neck cancers.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Talya and Jeff, it's really great to speak to you.

Dr. Talya Salz: Thank you for having me.

Jeff White: Great to be here.

Dr. Fumiko Chino: Talya, do you mind starting us off on how you got interested in trying to improve survivorship care, and specifically what gaps your research can fill?

Dr. Talya Salz: My research is really shaped by my experiences trying to navigate the health care system. I had some health issues in my 20s, and as a recent college graduate in a new job with my brand new health insurance, I was really shocked at how hard it was for me to find doctors that I trusted. It was hard to communicate what I needed and to get insurance to cover my care. That experience really steered me toward a career that addressed reasons why patients, and we're all patients at some points in our lives, have difficulty getting care that's appropriate, that's needed, and that's patient-centered.

So when I started doing health services research in cancer almost 20 years ago now, there was a growing consensus that after cancer treatment is over, after patients are told there's no evidence of disease, that they're cured, there are so many more health issues that can arise that had historically been neglected. And late effects of cancer treatment can last long after treatment is over, or they can pop up months or years later. All the distress and anxiety from cancer, that doesn't just vanish once the treatment is complete.

One problem is that there's no agreement on who should manage late effects of cancer treatments after treatment is over. Survivors have fewer appointments with their oncology team, and these visits traditionally focus on monitoring for recurrences and new cancers. Many oncology providers feel that late effects of cancer are realistically difficult to manage in the brief post-treatment visits or that these issues are out of their purview. So survivors are typically expected to return to the primary care they were getting, or maybe they weren't even getting it, before their cancer. And a lot of research has shown that primary care providers feel ill-equipped to address all the health issues stemming from cancer and cancer treatments.

Cancer survivors can feel a real burden by this transition from oncology-focused care to more general preventive care. In my survivorship research, I hope to understand and improve how cancer survivors' long-term health issues are managed as they navigate from cancer-focused to ongoing survivorship care.

Dr. Fumiko Chino: What a great and thorough answer to that question. I love the idea that you took the kernel of your own experience and then translated that into an entire career to try to improve the lived experience of cancer survivorship and outlined so many key friction points that survivors really face when they transition into this long, hopefully, road of survivorship.

Jeff, I think I've known you since the entirety of the eight years you've been at ASTRO, and I immediately thought of you as the perfect guest for this podcast focused on improving head and neck survivorship communication, as you are a communication specialist. Do you mind speaking a little bit about your role within radiation oncology and then how this became both the best and the worst background to have when you were yourself diagnosed with cancer?

Jeff White: Sure. Yeah, as you mentioned at the intro, I've been with ASTRO for about eight years and was brought in to kind of elevate the specialty as much as possible, either through media relations, social media, and partnerships and other things like that. When I came to ASTRO, a lot of people were saying to me like, "Wow, how are you and why are you working in cancer every day? Like, that's pretty heavy and that's pretty intense." And my answer was always, "You know, cancer is not really an issue within my family." So I didn't feel a huge connection. I was concerned about health care and access and things like that, but I wasn't really personally connected to it. So I thought, you know, I've been working day in and day out reading about cancer, understanding the different types of treatments for the different types of cancers. There were a couple of moments, and I distinctly remember working with Dr. Paul Harari when he was the ASTRO president, who happens to be a head and neck cancer specialist. He was talking me through kind of the whole process for treatment, and I distinctly remember saying to myself, "I don't ever want to get head and neck cancer. That looks pretty rough."

The irony is that here we are in 2023. I had a lump in my neck right after I had a physical, so I'd gotten all my... everything was good, my blood work was clean. And just this random lump appeared one day. So I went to my primary, and he was immediately concerned, "I think that you should go get it biopsied." And so that kind of started me down the path.

The good news was is that when I had the lump examined, it was a benign cyst. So I breathed a sigh of relief, and the doctor was like, "Great." He's like, "If you want to get it removed, you might want to go see a surgeon." So I kind of casually made an appointment to see a surgeon just to kind of get this little annoyance removed. And within two minutes, the surgeon was like, "I don't think that's what that is." He's like, "I think you have tonsil cancer." So that kind of started me down the path to kind of learn more about it, and obviously was biopsied and it was confirmed that it was cancer.

You know, that just took me down a whole path that I wasn't prepared for in any sort of way. I knew enough to be scared, but I also had no concept for what it really was until I kind of experienced it myself.

Dr. Fumiko Chino: I know you're so well integrated into radiation oncology through your role within the society. Do you feel like that gave you a leg up, at least in terms of getting a second opinion or facilitating the actual care?

Jeff White: I was able to connect with a radiation oncologist right away. I initially was told it was going to be three weeks to get a biopsy, and I just about fell apart because that was like... I couldn't possibly wait that long. So I will... you know, that was a blessing to have a connection in that respect. But I did, I shopped around. I live in Washington, D.C., so I am very fortunate that I have access to three top-notch facilities within a pretty close radius. I recognize that not every patient has that, but I was able to kind of find a place that kind of worked for me, that I felt comfortable with the team, I felt comfortable with the machines that I was going to be interacting with.

I also distinctly remember being in a waiting room looking at the patient materials, kind of reading it and thinking, "I've got to use this experience for good. Like, it's the only thing that could kind of calm me down a little bit because I was so panicked." And I thought, "I've got to use this as a learning experience and something that I can share with other people, and that might make this whole odyssey feel like there's a purpose to the whole thing."

Dr. Fumiko Chino: That's a lovely sentiment, the idea that you would use your lived experience to try to improve knowledge and education for other patients down the road once you got through it yourself.

Now, Talya, just to feature a little bit on the actual manuscript, do you mind giving us an overview about what you did, what the HN-STAR trial found, and what are you excited about in terms of the next steps?

Dr. Talya Salz: The goal of our trial was to improve the management of late effects for people who had finished treatment for head and neck cancer. As you talked about before, people with head and neck cancer can experience many ongoing challenges after treatment's complete. It's really sensitive anatomy, and there can be really aggressive treatments that can cause challenges with eating and breathing, speaking, movement, not to mention ongoing distress, fatigue, insomnia. There are comprehensive guidelines for the care of head and neck cancer survivors which include recommendations for monitoring and managing more than 20 of these late effects. The problem is integrating these recommendations into clinical care, and it may be hard to identify all the relevant concerns that survivors have and then manage them in a brief clinic visit.

We've learned from research among people undergoing active cancer treatment that asking people about their symptoms with standardized surveys, what we call patient-reported outcomes, can improve their symptoms, their quality of life, their communication with their providers, and even survival. So my team hoped that we could use patient-reported outcomes in the post-treatment setting for head and neck cancer.

To do this, we developed a web-based interface so that head and neck cancer survivors could complete surveys online, these are the PROs, about their symptoms before routine oncology visit. Those survey responses were used to identify concerns that reached a threshold that we deemed burdensome. We used that information to personalize a clinical decision support tool that the oncology provider could use in clinic on a computer or on a tablet. The clinical decision support tool presented each health concern and how burdensome it was to the oncology provider, and the provider could click on any of the concerns to see the guideline-based recommendations for management, whether the management was further testing, referrals to other providers, medications, or self-management.

There's more to the web-based tool. This tool is called HN-STAR, but those are the pieces of HN-STAR that are relevant to today's discussion. We hoped that when oncology providers used HN-STAR, clinic discussions could focus on relevant symptoms and concerns. Basically, the goal was to streamline and tailor care based on survivors' concerns.

In our trial of HN-STAR, we randomized 28 community oncology practices to either use HN-STAR or to provide usual care to head and neck cancer survivors in their practice. We enrolled 357 survivors at these practices. Survivors in both arms were asked to complete PROs for 26 concerns prior to a routine post-treatment follow-up visit, and after the visit, survivors in both arms were asked which concerns were discussed in clinic.

What we found was that these were very symptomatic patients, with an average of seven and a half burdensome concerns. In both arms, an average of five concerns were discussed in clinic regardless of whether the survivor reported the concern as burdensome. However, in the HN-STAR arm, an average of four of survivors' burdensome concerns were discussed compared to an average of three burdensome concerns that were discussed in the usual care arm. So importantly for survivors in the HN-STAR arm, 59% of their burdensome concerns were discussed in the clinic visit compared to 45% of burdensome concerns for survivors in the usual care arm.

This means that clinic discussions did not have a broader scope. The same number of concerns were discussed, but the discussions in the HN-STAR arm were more tailored to salient survivor concerns. This is not actually the main endpoint of our trial. We hope that these more tailored clinic discussions translate to improved care and improve health-related quality of life after a year, and we're still collecting these data. But we think it is really promising that this clinical decision support tool can streamline discussions between providers and head and neck cancer survivors.

Dr. Fumiko Chino: Now, Jeff, I would really love your thoughts on this trial and then about your own, sometimes maybe bumpy, transition into survivorship. So for example, what has worked for you to facilitate good conversations with your oncology team? And I would imagine given your active role within cancer education and communication that you actually have a leg up on some other survivors, but I would also still guess that there's a lot of opportunities to improve.

Jeff White: Oh, you'd be right on that. So the one thing that popped into my head as you were talking about this, Dr. Salz, was the timing of this. It really... getting my input or getting a patient's input at a certain point within the timeline is important, and it also... I like the idea that I could do it on my schedule versus feeling the pressure of being asked a question in person at the appointment because there's a lot of anxiety. You want to get the appointment over with, but like, if you have the time to really think through like, "You know, this actually is more problematic. I do want to kind of talk about that." I think that's very important.

I'm a communicator by nature, and so I feel pretty comfortable sharing. Plus I knew my doctor before I became his patient. But I will also be honest that I was hesitant to do too much research into what was going to happen for me long-term. I was overwhelmed, and I could only take in so much information, and that even included looking at my scans. And one of the things that I appreciated the most from my radiation oncologist was he was going to show me a scan after a PET scan, and I immediately froze because I did not want to see my body on that screen. And before he turned the light on, he said, "Do you even want to look at this?" And I said, "Nope. I don't. I really don't. You can talk to me about it, but I can't handle it." I just appreciated that he had the sensitivity to ask me that question because had he not, I would have been forced into a situation that I probably would have kind of fallen apart a little bit to see dark spots, you know, within my body and things like that. So…

The other thing I will say is that I didn't do a lot of  research, as I mentioned, kind of post-treatment of what to expect, so it actually was kind of a surprise to me the troubles I was having with swallowing. I literally just came from the doctor's today because I have these neck spasms. You know, I'm about 2 years out but I have these fibrosis issues and things like that. I can only take in so much content a time before I get overwhelmed.

Dr. Fumiko Chino: Do you think that the information that you were given, much less the information that you did or did not research for yourself, but that what was given to you was actually sufficient to help prepare you for survivorship?

Jeff White: I'm going to say 'no'. I went to a number of different facilities for surgery at one place and radiation and chemo at a different facility. I was looking to see what sort of education they were going to give me because I was curious, like, what do patients get? I knew what I had access to, and I was a little surprised at how little I was given. There was some talk about things. I will say that especially, I'm going to say on the surgery side, they kind of breezed through the bad stuff very quickly, verbally, and that was it. If I missed it, I missed it. On the chemo side, I was given a multi-page document that I actually did read before it all started because I didn't know much about chemo, so I did read that. And then obviously on the radiation therapy side, you know, I knew enough to know kind of what was happening.

But I also chose to take it day by day. That just worked for me. I just was like, "Today is Tuesday. This is what's happening today." Because I couldn't think about... you know, and this was Day 7 of 33, and I just kind of went day by day by day and just took it as it came.

Dr. Fumiko Chino: I appreciate what you said about the idea that the provider really needs to tailor the level of information and the delivery to the patient, right? Which is you got... he got the signal that you did not want to look at your PET scan just either by non-verbal communication or by the look on your face. He said, "You know what? We'll skip this part." And again, I think that is a really important part of the cancer survivorship, treatment survivorship journey.

Talya, a recent JCO OP article, other than your own, from your colleagues within MSK used a patient portal document to try to elicit patients' core health-related values to better inform medical decision making. Amongst other things, they found that almost all providers found that the answers, when they were available, were quote-unquote "worth the time to review," although less than half, 42%, found them always or often helpful. And I'd actually love your perspective on this because one of the key points of improving how we implement patient-reported outcomes is that providers need to actually respond to them and change their behaviors.

Dr. Talya Salz: Yes. I have two thoughts about this. I love this study because it actually integrated this assessment of values into clinical care to see how it was used in practice. And this value assessment is another version of a PRO, just like we used in our study, and it was used to inform an upcoming clinic visit. There was a built-in use for it. And actually, just to make the point, in our study we didn't just provide the PROs to the providers; we actually gave them some actionable information, and we'll see in future analyses whether they used it.

The second point about this is that feasibility is a huge piece of this puzzle to improve patient-centered care. Patients have to complete the PROs, and they're sick, they're busy, they're inundated with surveys, they're inundated with other forms, billing, etc. And then at the same time, oncologists have to use the information. They can find the information valuable and helpful as these providers did, but they have their own constraints. Their clinics are busy, and having something be worth the time spent is a real struggle. So if a new process isn't woven into the workflow, it's unlikely to change care. So new processes have to be considered worthwhile and made easy to use. Implementation science, which is research to understand how we can implement research findings into practice, is really critically important here when we think about making changes to care delivery.

Dr. Fumiko Chino: Absolutely. We can't just do a study and then just assume it's going to happen because time and again, decades of research has not translated into actual benefit to patients if not implemented. So 100%.

Jeff, there was a recent JCO OP Art of Oncology Practice piece called "Patient Empowerment through Shared Decision-Making," and it speaks about the balance of, and this is a quote, "between beneficence which can be paternalistic and patient autonomy that requires a carefully crafted art." And I obviously think we still need to improve tailored communication within oncology to talk about the things that actually matter to patients, not just what we think is important as providers. This was one of the highlights for the HN-STAR intervention to me; it really helped facilitate those patients discussing the things that mattered the most to them.

Jeff White: Yeah, I actually really loved that study. I felt that the empathy that kind of came through in that piece was really impressive. And, you know, I 100% believe that each of my physicians, you know, had nothing but empathy for me. But they also were seeing multiple, multiple, multiple patients per day. And there was a line in there that really resonated. It said, "Cancer wreaks havoc on human lives." And I can't... I mean, I'm going to get emotional because it's like... that is so incredibly true. It throws everything in your world off, and you feel completely out of control. The next line said something, "but we can afford some control."

I have kind of reflected on like my anxiety levels which were extremely high in the process of getting the diagnosis and figuring out the treatment. Once I was in treatment, I think my anxiety went down a little bit because I was actively doing something and I was actively, you know, seeing doctors every week. Once I finished my radiation, my radiation oncologist was like, "Okay, see you later. You're going to now meet with the nurse practitioner." And I was like, "What? What do you mean? Like..." That was really jarring to me. And, you know, as much as I loved her, I was like, "What do you mean? Like, I'm still struggling here." And the struggle was real for many, many months. I didn't feel as prepared in that respect for kind of what was going to happen in the weeks and months afterwards and the anxiety of waiting for my first post-PET scan.

I don't think I answered your question in any way other than to say that like, I feel like there are so many different touch points for the patient to kind of check in and kind of see how they're doing. And I felt connected to my team, and I'm obviously not a shy person, so I was sending messages through the portal even just saying like, "I'm really struggling here. You know, this is way harder than it was... you know, was presented to me. Like, these mouth sores are no joke, man. Like, that was rough."

Dr. Fumiko Chino: Did you feel like you had to advocate for yourself to get speech therapy, occupational therapy, to see the right specialist to treat your ongoing concerns?

Jeff White: I was lucky because I was at a cancer center that was multi-faceted, so I had access to... I even had access to mental health support. At first I said, "No thanks, I'm good." My best friend is a therapist, so I felt like I had a person that I could kind of talk to. But after a while I was like, "You know what? I think I need to talk to an outside, like, third party that, you know, doesn't know me to kind of help process all this." And so I do feel thankful that I had access to acupuncture and massage and all that, you know, lymphedema treatments and things like that. I didn't know I was going to need all that, but it certainly is something that I've used over the last months and year.

Dr. Fumiko Chino: Now in survivorship, do you know the full span of what we can do, and +/- how it could help you? Because I've actually talked to some survivors that are like, "I didn't even realize that there was a sexual health specialist that I could have talked to about my ongoing concerns, because no one ever thought that my treatment for X cancer could affect my sexual health or my whatever."

Jeff White: Well, what have you heard about me? What has my partner told you? No, I'm just joking. I do feel like the cancer center I went to is so comprehensive and there was a range of services that I could tick off if I was interested. So, I do feel thankful for that. I also remember that, when I was undergoing radiation therapy, I was the only head and neck cancer guy. It was all prostate cancer. So in our little men's waiting room it was me and like 6 guys that were all undergoing prostate cancer treatment. And so we kind of built a little cohort in that respect.

The other thing I'll say is that I didn't realize the online community was so strong. I did actually have access to a support group through the cancer center that didn't work for me. It just wasn't... these were people that had very severe post-treatment issues, and I, you know, was just like a little newbie and they were like, "We don't have time for you." Like, "We've got bigger fish to fry." But Reddit has been amazing. So I locked into Reddit post-treatment, and I kind of wish I'd known about it while I was in treatment because it's patients talking to each other. No one's pretending to be a doctor. There's no fake stuff out there. There's no misinformation. And it's really people that are like, "I have the, you know, I have this similar cancer and here's what kind of worked for me." So I've been pretty active on there in the last year.

Dr. Fumiko Chino: I love what you brought up, this idea that the communities can be really tailored to the individual, how they best receive information. So for an online community that worked better for you than like the quote-unquote "authorized" patient support group. And what works for one person may not work for another person. So I think it actually harkens back to the trial, which is that, hey, patients should actually say "This is the thing that bothers me most. Can we talk about this?" Because for some people it might be neck spasms, for other people it might be dental caries, and for someone else it might be how they look and feel about themselves.

We are at the end of the podcast. I do want to leave a little bit of space for anything that you feel like we haven't covered yet. If we want to talk about surveys, if we want to talk about the community site research NCORP of it all, because I think there's a lot of opportunities to think about, for people who can't be treated at cancer centers that have all of the bells and whistles. For community practices, how do they actually improve survivorship care? I'd love to just open it up. Any last thoughts?

Dr. Talya Salz: I was thinking about what you said, Jeff, in terms of all the opportunities that were available to you at your cancer center. And I also come from a... work at a cancer center where all of these services and opportunities are broadly available, at least they're in place whether or not people use them and can afford them. But it was really important to our team that we make sure that our intervention works for people in community oncology settings.

And we worked with the NCI's Community Oncology Research Program, or NCORP, through the Wake Forest Research Base. The NCORP is dedicated to enrolling cancer patients who are treated at community oncology practices across the country into clinical trials, including cancer care delivery research trials such as the one that we did. And it was really important to us to be able to create a tool that would work in these settings. There was a real range of services that are available at these community oncology practices. I mean, some of them did have mental health services on site, some of them did not; speech and swallow rehabilitation therapist - some sites have them, some sites do not. And so it was a real challenge building a tool that could be flexible enough that providers could select options that were realistic for their patients. So I'm really grateful we had the opportunity to work with them. It was a great experience, and we ended up with a pretty racially, ethnically diverse group of cancer survivors, including a significant minority from rural areas of the country too. That was a real strength for us.

Dr. Fumiko Chino: I would be remiss not to mention that NCORP is funded by the NCI, and the research that comes out of NCORP is not possible without strong federal government funding, which is the thing that is exactly at risk right now in the current restrictive funding environment.

Dr. Talya Salz: I hope that my vocalizing my support while you were talking did not get in the way, but that is extremely important that this kind of research continues to be funded by the NCI and actually the American Cancer Society funded a lot of this research as well.

Dr. Fumiko Chino: Thank you so much for this amazing conversation today. Many thanks to both Dr. Salz and Mr. White, as well as our listeners. You will find the links to the papers that we discussed in the transcript of this episode.

If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, I hope your winter is warm and bright.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Talya Salz

No relationships to disclose

Jeff White

No relationships to disclose

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an associate professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

CAR T-therapy is an advanced cancer treatment that biologically engineers a patient's own T cells to recognize and kill cancer cells. It has shown remarkable benefits, leading to long-term remission or even cure for select patients with hematological cancers that have not responded to other treatments. Primary trials were exclusively conducted in the inpatient setting due to high risk of quick onset and life-threatening toxicities requiring close monitoring and immediate treatment. Advances in symptom monitoring and care delivery have allowed the introduction of outpatient CAR T, which is cost saving and more patient centered. I'm happy to welcome two guests today to discuss this promising operational shift.

Dr. Navneet Majhail, MD, MS, serves as the Physician-in-Chief of Blood Cancers at the Sarah Cannon Cancer Network, where he oversees 10 transplant and cellular therapy programs that collectively perform over 1500 transplants and cellular therapies each year. He is the first author of the JCO OP manuscript, "Outpatient Administration of Chimeric Antigen Receptor T-Cell Therapy Using Remote Patient Monitoring," which was published earlier this year.

Ms. Laurie Adami was President of the LA-based Interactive Data's Fixed Income Analytics Division when she was diagnosed with stage four follicular lymphoma at age 46. From 2006 to 2018, she was in continuous treatment and received multiple lines of therapy, including three clinical trials. In 2018, she received treatment number seven, a clinical trial of Kite CAR T-therapy. Thirty days later, she was in complete remission, where she remains today. She is an active patient advocate and legislative policy advocate for several not-for-profits.

Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the podcast today.

Navneet and Laurie, it's so wonderful to speak to you today.

Dr. Navneet Majhail: Thank you. Looking forward to this conversation.

Laurie Adami: Thank you, Dr. Chino. I guess I'm supposed to call you Fumiko. Great to be here today. Great to be alive, first of all, and great to be here on this call. Thank you for having me.

Dr. Fumiko Chino: I think with everything you've gone through, Laurie, we all go on a first name basis.

Now, Navneet, do you mind starting us out with a short history of CAR T in the US, including the side effects and the precise care delivery needs that were the initial reasons why care was limited to the hospital?

Dr. Navneet Majhail: So, Fumiko, you laid an excellent background as to why these therapies are done in the inpatient side and what they are. I mean, it's really exciting, right? These are what we call transformative therapies in oncology or medicine as a whole. You're taking patients with very, very advanced diseases who traditionally would have gone on to hospice, where you can potentially put around half of these patients into very deep remissions, and maybe some of them might be cured of their underlying malignancies.

Now, having said that, as you alluded to in the introductions, most of the trials early on were focused entirely on the inpatient space for a few reasons. One was the unknowns. These were early therapies, unknown side effects, you needed to have that monitoring. The second, some of the very early work that was done with these therapies, it was clear you can have some potentially severe and fatal side effects, like cytokine release syndrome, what we now call ICANS, or immune effector cell-associated neurotoxicity syndrome. You have issues such as HLH, hemo-phagocytic lymphohistiocytosis. These are some really fatal, potentially fatal and severe side effects, which really needed close monitoring on the inpatient side.

As things have evolved, obviously we've gotten smarter at selecting patients. The constructs have improved as well, where the incidence and the severity of these toxicities has gone down. And as we become smarter overall, both from a supportive care, patient selection and technology perspective, certainly there are opportunities now for us to look at delivering these care where patients can access these therapies better.

Dr. Fumiko Chino: That's a wonderful summary, and I know at this point, I believe over 300 sites are Foundation for the Accreditation of Cellular Therapy accredited to deliver CAR T-cell therapy. So, we really have gone very much into the space where we're trying to expand access to these therapies.

Now, Laurie, I know that your CAR T was in 2018 on a phase two trial at UCLA, but your treatment started in 2006. Do you mind walking us through what that was like for you? How did it go? What was required in terms of travel, time, for, I know, again, just not just yourself, but also your family, and it's through the treatment and then also the recovery? I'm presuming that you had to be in the hospital, for example, for your CAR T for at least a week, if not longer.

Laurie Adami: Yeah, I was diagnosed in 2006 and spent 12 years in continuous treatment, all in Los Angeles where I live. When I did my CAR T, I was also in Los Angeles, so that made it easier for me, as well as my family, because when I went in for CAR T, I was just at the UCLA main hospital, which is about 20 minutes drive from my home.

The process for 12 years was difficult at every level, both physically as well as emotionally and mentally. My son was only in kindergarten when I was diagnosed, and I was given horrible statistics up front in terms of my survival likelihood, but I was determined to stay alive, and thankfully for me, I was able to get into CAR T really at the end. And like Navneet said, I would have been going to hospice if the CAR T trial hadn't opened because I had literally burned through six other treatments, none of which worked.

Dr. Fumiko Chino: It's truly a transformative treatment, and I can only imagine that for you yourself, the burdens must have been immense. I know that you were an executive flying, it sounds like around the world. How did that change your life?

Laurie Adami: So I lost my career as a result of my illness because it was clear after my first relapse, after the only treatment that existed at the time, which was 19 years ago, that this was going to be a battle that wasn't just going to go away. And so, I was really seeking things constantly, and I would do a treatment, it would fail right away. It was really, really difficult at every level. So I had to go out on disability from my work, and then I was never able to go back, because by the time I finally got CAR T, then COVID hit, I couldn't start traveling around the world with my special immune system. Yeah, it was costly at so many levels, but thankfully, thanks to science and all of you doctors on this call for administering these therapies, I am so grateful to be alive.

Dr. Fumiko Chino: Well, that segues really nicely in terms of the next advancement of science, which is to take CAR T out of the hospital. Now, Navneet, do you mind giving us an overview of your JCO OP article, outlining key considerations for outpatient administration of CAR T, so discussing things like remote patient monitoring and what is really required in terms of the investments from the cancer center?

Dr. Navneet Majhail: Certainly, Fumiko. At the end of the day, as we considered moving these therapies to the outpatient setting, there were two big problems we were trying to solve. One was the capacity issues. I mean, again, we've had increase in the utilization of these therapies, at least across our network, at the rate of like 15 to 20% per year, right? So that's your trajectory where it's heading, and there's a lot more indications coming down the road, and there's no way our health system or any other health system in the US has enough beds on the inpatient side to accommodate this, right? So one was, how do we address the capacity issues that are happening today and that we foresee happening in the future in an innovative way? And the second was, how do we make this therapy more financially sustainable? These are expensive therapies, just by the cost of the product and the care that's given around it. And the more we can do this in the outpatient setting, the less we use inpatient resources, everything that comes with the hospital stay, and would certainly make this more financially sustainable.

And I think as we think about moving this to the outpatient side, of course, across our network and for any other place that's considering it, a big component is patient experience and patient safety, right? Because as we discussed early on, there are some potentially really lethal toxicities that are associated with these products. They've gotten better. They are seen less often, and it's not very often that we see those severe toxicities, but they can come up very suddenly. We've got to make sure that you've got the pathways and everything else in place to manage those patients in a safe way.

So, we have a multi-site network. We currently have 10 centers that are a part of the Sarah Cannon Transplant and Cell Therapy Network. It's physician driven, and what we do is we like to standardize things as much as possible, so all sites can do the same thing, and we can monitor outcomes, data, and what's happening to patients in that context. So, where we ended up with is using a remote patient monitoring platform to essentially care for these patients in the outpatient setting. It's actually a pretty cool technology and a cool thing our teams came up with. I'm talking about this, but to be honest, I cannot take any credit for what our teams have done.

At the end of the day, we currently have a contract with an organization called Current Health. So, they have these kits, which include a remote patient monitoring device. It's an FDA cleared device, and it's essentially something that you slip onto your arm. It's a small, round, an inch-wide monitor. And what it does is it sends data on your vitals, your temperature, your pulse ox, your pulse rate, a whole variety of things, through Bluetooth technology to a central command center that's manned by trained nurses. And what we did was we worked with Current Health to essentially come up with the algorithms for what is a true indicator, potentially true indicator for complications like CRS, right? So if you're sleeping at night, guess what? Your pulse rate goes down, right? If you've just come back from a run, you'll be tachycardic, right? So if you're sleeping with three blankets on you, your temperature will go up, right? So how do we come up with these algorithms which take out the noise and really help us focus on what might be potential CRS? And I'll confess, we are always working to refine these algorithms, make them better as we go forward.

Once the nurse sitting in that central command center identifies a potentially true alarm, then we work with them to come up with the triage pathways and the clinical pathways for management so that the patient is triaged to the right care at the right time. So if they end up in the ER, what are the pathways for the ER to give tocilizumab very promptly, right, within 60 minutes of showing up there and so forth.

So that is what we have developed across our network from an outpatient care platform, and what we've seen in this context is that we still have around two-thirds of our patients who end up getting admitted in the outpatient setting. So we typically start as a start with the lymphodepleting chemo, and we'll keep it going through at least day 14 after the infusion of the CAR T-cells. And during this time period, around two-thirds of our patients will still end up getting admitted because with the slightest fever, we don't want to take a chance. We'll triage them quickly to the ER or the hospital. But then the median length of stay was only four days compared to our historical data where, as you can imagine, we would keep these patients in for a median of 16 days. So that's how we are managing these patients as we go forward. And like I said, we are doing a lot of research to see how can we make things better, how can we manage some very, very early CRS in the outpatient setting, for instance, and how can we keep refining the alarms and so forth?

Dr. Fumiko Chino: That sounds amazing, and it sounds like it's truly something that would not have been capable without some more advanced technologies in terms of remote patient monitoring. So we're truly galvanized by our technologies, telemedicine has really revolutionized, at least during COVID. So I'm assuming you're capitalizing on some of those advancements.

Dr. Navneet Majhail: We certainly are, and one of the interesting things I'd like to share, and maybe Laurie can comment on this or may validate this, right? So we collect the survey data, and we talk to the patients about their experience. And one interesting thing that came across these conversations was the fact that many patients and their caregivers felt more secure that there was someone potentially watching them 24/7 for these alarming signs. As you can imagine, as these patients come in, we scare them, right? "Hey, this is very, you know, innovative therapy. This might fix your lymphoma or myeloma, but hey, what, I mean, you got this bad CRS, you know, X number of people will die because of CRS and severe ICANS where you may get seizures and whatnot. But yeah, go home and sleep over it, right? So you can go home, you can stay in the outpatient setting, and come back tomorrow to see us, right?" So it was very interesting to us, that theme where patients felt that, okay, they had a level of reassurance that there was someone watching them. And that to me was very interesting as we collected that data together.

Dr. Fumiko Chino: Laurie, is that something that you've heard of from other patients, at least treated in the outpatient setting?

Laurie Adami: So I have not actually spoken to a patient who's had the monitoring on them. I've spoken to numerous patients who've done it outpatient and have been very scared, and their caregivers have been even more scared, because you know, not all caregivers are created equal. Some of these patient populations are older, and you know, there can be confusion. So, you know, I think the fact that these monitoring devices are going to become available will be immensely helpful, not only for the patient's well-being, but for their caregiver who's right now on the hook. If they fall asleep and miss the patient spiking a fever, I mean, this is the scary stuff. So, I think this is fantastic. I do wonder how you manage, how you figure out the ICANS part of it, because I know the symptoms you're talking about are primarily CRS. So does the monitor do anything that can gauge the mental activity or no?

Dr. Navneet Majhail: We are spot on that the monitoring is mostly focused around CRS. Now, for example, our program here in Nashville, the process we've set up is, so the kit that the patients use also has a tablet, through which you can have a video conference capability, right? So the process that we've set up here at the Nashville program where I practice is that one of our nurses will do a video call at 8:00 p.m. And again, I mean, you can imagine, I emphasize the team effort because you've got the outpatient clinic team, they'll have patients, as you know, there's a whole assessment that patients do, where they write their name, you know, a sentence and, you know, everything else. And at the end of the day, all that is basically passed on to the nurse who's on at night to do those assessments for patients. And around 8:00 p.m. or so, she'll or he'll connect with the patient through that video conference capability. They'll have them write that sentence and then show it on that video to see what it looks like. And then he or she can compare as to what it was 12 hours earlier at 8:00 in the morning. So it is not around the clock ICANS monitoring, but at least patients don't go 24 hours or more before getting that assessed.

Dr. Fumiko Chino: No, that's so helpful to kind of have that clarity. And I love what Laurie said that patients and patient caregivers actually kind of want this, the idea that there's more eyes on them and they're getting this sort of continuous monitoring. So, it sort of meets the brief in terms of optimizing time at home, but also reassurance for patients and caregivers.

Dr. Fumiko Chino: Now, Laurie, I had watched your interview on The Patient Story, and you had said something I thought was quite striking. You had gone to four different large cancer centers for various treatments, that ultimately led to your cure with CAR T. Do you mind speaking about how access to specialty care can be really a barrier for patients? I know that you had said previously that you felt lucky to live in LA. And I'm assuming that's not just for the nice weather.

Laurie Adami: No, it's not. I'm from the Northeast, and I'm still a Northeasterner, but being in LA where I could get to so many care centers so easily within an hour was a real bonus for me. The other thing that I was lucky to have was good insurance. So I had PPO insurance when I was employed, and that allowed me to see specialists. And I talked to many, many patients now, you know, probably over 50% of patients get diagnosed in community oncology settings and/or community hospitals, and oftentimes those settings don't have specialists. So I speak to patients being treated at Kaiser where they don't even have a lymphoma specialist. And so they're not being given necessarily the best information about the available treatments, and they may never even hear of CAR T.

So, it's a real problem for a lot of patients to get to specialists, and unless you're seeing a specialist, you're unlikely to hear about these newer modalities of treatment, immunotherapies, small molecule drugs, CAR Ts, much less likely if you're seeing a general oncologist. They're not going to know about it. And what do they know about chemotherapy, auto stem cell transplant, and allo stem cell transplant, which is being done for over 50 years? And so I'm still speaking to many patients who can't get CAR T because their insurance either won't pay for it, or they live in a state where there are no CAR T centers, which believe it or not is still the case in the United States today. There's still a small number of states where you have to travel two or three states to get to a CAR T center, and you have to get a referral from your community oncologist, and there's no easy mechanism for that happening back and forth. And I'm working on a couple initiatives with some focus groups to make that better, but it's a real struggle.

And that's why I was lucky. I had good insurance, I lived in LA, I was treated at four big cancer centers, and within an hour, I could fly to San Francisco or San Diego to see more specialists. So it's really a function of when you're diagnosed, what is your insurance? What assets do you have? What benefits do you have? I speak to patients who if they don't go to work today, they don't get a paycheck. They can't miss a day to travel eight hours to go see a specialist. So there's a real problem with access in the United States and a real problem, I think, with bifurcated health care.

Dr. Fumiko Chino: I love that you have used the privilege that you did have, even in the context of a stage four diagnosis, and then used that energy that you kind of came out of it to continue to advocate aggressively for other patients. So I, you know, I applaud you a thousand times for that.

Now, Navneet, can you talk about the access barriers from the provider perspective? I know that you had mentioned capacity building in the OP paper and about how outpatient treatment facilities programs development in the community oncology practices could certainly help ease some of these geographic barriers to care that Laurie just so eloquently brought up.

Dr. Navneet Majhail: So, Fumiko, to put this into context, let me start with some numbers first. So if you look at the number of patients in the United States who can potentially benefit from a CAR T-therapy for the currently approved indications, one in five patients gets it. So I'll let that sink in. Despite all these transformative therapies we've talked about, only one to in five to one in four patients who needs a CAR T-therapy will get it. And some of the research that we have done and others have done, once you get to a treatment center, right, so once you get to a treatment center - so you've bypassed all those geographic, insurance, many of these other access barriers to a CAR T-therapy - once you get to a treatment center, two out of the three patients will end up getting an infusion or treatment. So there's still a third of these patients who will not get an infusion once they hit a CAR T center, mostly because their disease is too advanced by the time they show up. So these are the high-level numbers that put into perspective what the delta is, right? What the gap is that we need to solve as we go forward.

So now, as you think about the access barriers, I think Laurie, you were spot on some of the education gaps across many of our colleagues in the community where they may not be aware of the indications, the advances, and the opportunities around CAR T-therapy. So, obviously, I think that's a big issue. Even on the provider side, even though they are patient-centric access barriers, I mean, we feel it too, geography, trying to get patients into see us, right? Some of the insurance barriers you talked about, I mean, the health disparity issues that I think Fumiko, you're very familiar with. And as you can think about a therapy which is expensive, is limited to select sites, all those access barriers that we face across oncology just get accentuated. They get multiplied.

As we think about the community practices, as, and you're spot on, I mean, how do we increase access? A big opportunity is getting these to the community sites. I think provider education is a big one. The capacity pieces, how do we build capacity is a big one. And I think the third one is what I call the economics of care delivery. What that means is not just the cost of these therapies, but things like the infrastructure that needs to be built up, the people you need to hire, train, get to a good place, all those pieces, apheresis, for example and so forth. And then all the reimbursement, revenue cycle pieces that as a practice you have to deal with. So these are some of the barriers at the community practice levels people feel as you consider accessing these therapies.

Dr. Fumiko Chino: Absolutely. You know, Laurie, did you have anything to follow up with that?

Laurie Adami: I just wanted to comment on this financial issue because I know Navneet talked about the high cost of these therapies, which is completely valid, but if you look at the treatment that I had prior to my CAR T, I had over $3 million in costs billed to my insurance. That was before CAR T. So, one of the therapies that I was on in a clinical trial, where I was actually the long tail in the trial, was a PI3 kinase inhibitor trial that I was on for almost six years. And while it never got rid of my cancer, it bought me stable disease. I stayed on that pill for almost six years. It bought me stable disease to allow me to get to CAR T. But that drug got priced for $180,000 a year, and I was on it for six years. Right there, that's almost $1.2 Million.

So, I think if you look at the alternatives, you find out that really CAR T is not, I mean, yes, it is expensive, for sure, but you know, if you look at something like an allo stem cell transplant, which was being tossed at me over the 12 years as an option, that's far more expensive than CAR T, because not only is it a very long time in the hospital - they were telling me to expect up to three months in the hospital - but then a lot of patients have terrible graft-versus-host disease, so you spend the rest of your life in medical care. So, I just wanted to raise that point, and to the extent we can reduce the hospital costs by taking these treatments to patients outpatient, that will be a huge benefit, because that can be half of your cost in hospital stays. When I was in the ICU, I think it was $38,000 a night for one ICU night. So these hospital stays are very costly. But I did want to just point out that it's kind of painted as black and white, so expensive, but I think we have to contrast it for all the other options patients are getting. You know, if you're on a drug for many, many years, a small molecule drug, those drugs are very expensive. And if you can do a one time, one and done, you're far better off financially.

Dr. Fumiko Chino: Absolutely. And I think, and this is not to put it in such stark terms, but I'll say this as a cancer widow, dying in the hospital is very expensive, and it is a terminal diagnosis and then in the ICU, we're talking about incredibly expensive and by definition morbid and mortal. So if we're saving lives and creating cures, that's a high-value proposition.

Now, Laurie, it is very clear that you're a very engaged patient, and I know you've spoken before about how you were very active in your care in terms of researching new treatment options, going to clinicaltrials.gov. Can you speak a little bit from your experience both as a patient and an advocate about how access and knowledge has improved a little bit over time? For example, the Leukemia and Lymphoma Society was recently renamed to the Blood Cancer United, but I know they have a clinical trial support center, and I know that you have played a role as a peer mentor for some other patients, so I would love to hear more about that.

Laurie Adami: Sure. Yeah, so when I was diagnosed 19 years ago, there were very few tools, and it was really a struggle for me to get information. And yes, while I use clinicaltrials.gov, I found it was full of false information. It wasn't updated promptly, and I was very concerned, and then I found out the FDA didn't approve what goes into clinicaltrials.gov. So there's a lot of junk in there. And when patients say, "Oh yeah, I'm looking at clinicaltrials.gov," I'm always encouraging them to reach out to a nonprofit that is focused on their area because that's the best place to get valid information.

Now, the problem is most people don't know about nonprofits because outside of the American Cancer Society and Susan Komen, very few nonprofits spend any money at all advertising because their mission is to cure the disease they're focusing on and to make sure patients get the financial help they need. So the money that they're raising is going to research and helping patients. So you don't see advertisements on TV, "Oh yeah, if you need to find a clinical trial for pancreatic cancer, call PanCAN Action." You just don't see it.

So I had to figure that out on my own, and now it's amazing what organizations like LLS or Blood Cancer United are doing because you can call them, and I've called on behalf of many patients, I've provided all the pathology information and the treatment history. Within 48 hours, they return a list of all the trials that you qualify for in whatever geographic region you request, and it's at no cost at all. And Blood Cancer United will actually call - I just hooked a patient up with a trial at the National Institutes of Health, thankfully a trial that didn't get shut down yet - and they actually called on behalf of that patient to make sure that they were still accepting enrolling patients.

So that's something that I think most patients don't know about, and I wish physicians, when they diagnose their patients, I wish physicians would provide resources. You know, "You should reach out to Blood Cancer United or Lymphoma Research." But the problem is most of these big academic research centers are also doing their own fundraising. So they don't really want to connect you with another nonprofit that's raising money. So it's kind of a conflict a bit. I mean, I know they want to do the best for patients, but they're restricted in terms of what kind of information they can hand out to the patient. And I've always wanted to put like pamphlets in my oncologist's office because when you get diagnosed, no one ever expects to get diagnosed, and 40% of people in the United States are going to get in their lifetime diagnosed with cancer. So you are going to have that bomb go off, a lot of people are, and you don't know what to do. And if someone had told me back when I was diagnosed, these nonprofits have resources, reach out, there are support groups, there are patients you can talk to, it would have saved me so much time and aggravation, and I just had to figure it out on my own. And sadly, that's still the case in large part.

Dr. Fumiko Chino: I love this siren call to be an activated patient, but also for providers to really think about the full dynamic of care for the patient in front of you and to not be narrow in your institution, but to really think about what are all of the resources that we can marshal around everyone.

I do want to leave a little bit of space at the end if there's anything that you feel like we didn't cover.

Dr. Navneet Majhail: Yeah, again, I think, Fumiko, we're still evolving in the field. As we think about where the field is going, we'll have constructs hopefully in the solid tumor space. Autoimmune diseases are coming. We're all excited about that. But I think going back to the fundamentals, so how do we take care of patients well? It's not just the care that happens in the context of the first few weeks before and after infusion, but then how do you watch these patients lifelong to look for late effects, survivorship issues, and so forth as you think about it. And I know we didn't get a lot of time to talk about this, but especially since your focus was how do we take this to the community, a big piece is ensuring the quality of care these patients receive in the community. You mentioned FACT early on and its role in ensuring high-quality care, it becomes even more relevant in the context of outpatient care as we think about these therapies.

Dr. Fumiko Chino: Absolutely.

Now, Laurie, last thoughts from you?

Laurie Adami: So I did want to add that we talk about CAR T and all the risks of CAR T and the long-term follow-up because I understand it's a genetic tool, right? This is not just chemo pills coming off a factory line. This is using your own immune system, modified, etc. But I think we also need to remember, if we contrast it to the brutal treatments I had before CAR T - CAR T, I'm not worried at all about that. If I get secondary cancers down the road, because I was so heavily treated, and most patients as of right now have been heavily treated. They've had radiation, they've had chemotherapy. We know those cause secondary malignancies. All of my side effects have to do with my prior six lines of treatment, not with CAR T. So I just want to remind everybody that, you know, we look at this in a vacuum, but the old stuff wasn't so great either. And maybe we should talk about how these patients are doing after those therapies. Anyway, that was it.

Dr. Navneet Majhail: Laurie, I was going to say, thank you so much. I'm going to take so many of your quotes and enlarge them and put them in my clinic. You've been incredible.

Laurie Adami: Reach out anytime, and if I ever get to Tennessee, I'll come see you. I'll buy you dinner.

Dr. Navneet Majhail: Looking forward to that.

Dr. Fumiko Chino: I love the idea that every single provider will have quotes enlarged from a patient advocate who was treated for their disease site in their clinic, because if there's anything that we can learn outside of the science, it's from the lived experience of cancer treatment and survivorship. I want to thank you so much for this great conversation today.

Many thanks to Dr. Majhail and Ms. Adami, as well as our listeners. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, please stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Laurie Adami

Stock and Other Ownership Interests

Company: Gilead, Merck, Pfizer and Universal Health Services

Navneet Majhail

Stock and Other Ownership Interests

Company: HCA Healthcare

Consulting or Advisory Role

Company: Anthem, Inc

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for JCO Oncology Practice. I am Dr. Fumiko Chino, an assistant professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

There are over 450 million podcasts available today, and online audio consumption continues to rise year after year. In the US alone, over 200 million people have listened to online audio in the last month, and health and fitness remains one of the most popular categories. Podcast audiences range from the lay public to patients with cancer to providers, with the dual goal to both entertain and inform. A recent randomized control trial published in JCO OP reported that a podcast-based curriculum could improve knowledge and comfort with common education topics for oncology fellows.

I am happy to welcome two guests today to discuss the role of podcasts to improve information sharing. They are both podcast hosts, making this ASCO's first podcast about podcasts.

Dr. Vivek Patel, MD, is an assistant professor and APD at Vanderbilt University with a treatment focus on blood cancers. He co-founded the Fellow on Call podcast in 2021 to fill a perceived gap in high quality, free, online medical education content in Hem-Onc. The podcast provides the fundamentals, core concepts, and important management approaches in an easily accessible, asynchronous learning platform. He is the first author of the JCO OP manuscript, "Education Impact of a Podcast Curriculum for Hematology-Oncology Fellows," which was simultaneously published with his oral presentation at the 2025 ASCO Annual Meeting.

Dr. Eleonora Teplinsky, MD, FASCO, is the Head of Breast and Gynecological Medical Oncology at Valley Health System and a clinical assistant professor at Mount Sinai. She is the host of the Interlude podcast, founded in 2018 with the goal to promote support, inspiration, knowledge, and hope to listeners via patient and provider interviews. She is also active on social media, providing real time expert commentary on active new stories from emerging research to celebrity diagnosis and treatment.

Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the episode today.

Vivek and Eleonora, it's so wonderful to speak to you.

Dr. Eleonora Teplinsky: Thanks for having us.

Dr. Vivek Patel: Glad to be here.

Dr. Fumiko Chino: Our specific topic today is podcasts as an avenue for knowledge transfer for both patients and providers. This conversation is loosely based on a manuscript that Vivek and team published on the findings of a randomized control trial of an education intervention.

Vivek, do you mind sharing with us how you got interested in podcasting and then briefly discussing what your study team did and the findings?

Dr. Vivek Patel: Yeah, yeah. So getting interested in podcasting really started when I finished residency and was starting Hem-Onc fellowship. There is a popular podcast, The Curbsiders, and I always listened to it when I was a resident to learn core concepts in internal medicine. When I got to Hem-Onc fellowship, there was a gap. And after my first year of fellowship, I met with a couple of my co-fellows and we just decided, "Hey, let's just make a podcast. Maybe it will just be for our program." It ended up being this bigger thing that we created with The Fellow on Call. So that that is really what the start of the journey was, was just, "Hey, there is nothing here. Let us just do something for fun," and then it just kind of took off from there.

For the study that we did though, what we really focused on was, there's been so many studies out there now that have looked at using podcasts and that people like them, people enjoy them, that they are convenient. But there are very few studies looking at, does podcast actually improve knowledge? And that is a very difficult thing to study. You know, it is really hard to do education research in general, particularly in the multi-center setting.

What we did was we designed a multi-center cluster randomized trial where we included 27 hematology-oncology fellowship programs and we randomized the programs to a supplementary curriculum in addition to the standard didactics with our podcast and another podcast that we work closely with, The Two Onc Docs, versus just standard curriculum alone, with a goal of understanding does fellow comfort level in a select set of topics improve and does their knowledge assessment in those topics improve as well? So we actually created and validated a knowledge test as well. We decided not to use the in-training exams because, you know, we figured, well look, these in-training exams cover a broad range of topics. We are really focused on our very key principles in a few disease areas. And the bottom line results were, it was a positive study. We found that the knowledge test scores improved by 15.5% favoring the podcast arms and fellows at the end of the year felt more comfortable in the disease topics that we had given them. So it was interesting to see that the podcast actually improved both comfort and knowledge in the set of topics that we had chosen.

Dr. Fumiko Chino: I love this type of pragmatic, cluster randomized trial which asks a really discreet but also important question, which is how can we be improving education? And also, I think making it more accessible, right? And that is one thing I think your podcast does amazingly, is that you really go into depth on these topics which are quite complex, and I think is useful not just for trainees, but also even practicing physicians that kind of want to bone up on these topics.

Now, The Fellow on Call podcast is a provider-facing podcast. It really focuses on education for trainees and the practicing provider. Interlude is a patient-facing podcast with a goal of sharing stories and knowledge about cancer survivors and caregivers. Eleonora, I would love your perspective on the role of podcasts in the cancer community and how your podcast differs in focus and framing from an educational podcast for trainees. And also, honestly, just given your role as a program director of a new fellowship program, I would love your thoughts about the findings from the study itself.

Dr. Eleonora Teplinsky: I love podcasts, first of all. I think they are amazing for learning, especially asynchronous learning, and we know everyone learns in different ways, right? So having more opportunities is so important. But I think it is really important to do studies like this and to highlight that yes, in fact, podcasts do help. And I do think it should be part of at least the offerings of how do we provide information and materials to our trainees. And I agree, it is not just trainees, right? Your maybe board preparation, something you can plug in in the car while you are driving. I think so many uses.

From my side, I think that podcasts also have a really good role on the patient-facing side. And so I will very briefly, I started actually first just educating on social media. This was right around the time where misinformation was starting to become rampant, and patients were coming in with questions. And you know, I felt like as I am sure we all do that 15 minutes is not enough time to spend with the patient and they were leaving sometimes with more questions than they came in with. And so I started saying, "You know what, let me just put this stuff out there online, no medical advice, but just educating."

And then I realized, wait a second, I don't really understand survivorship that well. I do not understand what our patients are truly living with because we were not taught that as trainees. Things have changed a lot, but back then it really was not a focus. And so I realized I just wanted to talk to patients, not my patients, people who I did not have a doctor-patient relationship with, just to hear their stories. And, oh my gosh, you know, the first one I did, I remember I said, "Wow." There was so much that I did not know about that experience. And so it's really helped me as well.

But I think putting it out there for patients who do not always feel comfortable asking questions online, going to a support group and speaking up, this allows them to, again, in an asynchronous way, to hear people's experiences and stories. And then over time I started bringing on experts. You know, Fumiko, you were on, and we talked about financial toxicity and radiation. These are questions that patients have, and it allows them to get information from a trusted source. And I will say, I think it really helps people when they have time, when they are not in a high pressure environment. On their own time, they can write things down. They really can process the information, and I think in a less stressful way, empowering themselves to then go to their doctor's appointments and say, "Hey, can we talk about these things? Right? Can we talk about ways to protect my heart during radiation?" All of these questions that maybe they did not even know they should be asking.

Dr. Fumiko Chino: I love that when you said you thought you were going to create this podcast as an education tool for patients, but that you learned so much about it. And I have to say, I have learned a lot from patient's stories and that really large engaged survivorship population. And having some of these conversations has been really invaluable to my ongoing education role. Hopefully all lifelong learners here, both on this call, but also our listeners.

The rise of podcasts aligns with how communication and education has changed in the modern era from in-person didactics to conversations on Zoom, social media, TikTok. Some of this has coincided with the 2020 podcasting boom during the pandemic lockdown, and some of it is really driven by younger patients and younger providers. They seem to learn better with the rise of alternative media formats that can better engage Gen Y, Gen Z. So for example, over half of the fellows on this trial already used podcasts as part of their baseline educational resources and only a quarter used textbooks.

Vivek, I would appreciate your take as a junior faculty member on how your education may have changed over the course of your training and how this continues to evolve based on what you have seen in the next generation of medical trainees.

Dr. Vivek Patel: When I was a medical student, a lot of the resources I used were textbooks, some of the traditional resources, and as I advanced on to training and went into residency, it became challenging to keep on reading textbooks and going through all of that. Podcasts are a convenient way to get that information, and I think as the younger generations are coming up, they are really interested in these short form videos and things like that. So it is really convenient.

The other nice thing about these podcasts, most medical podcasts will cite their resources, they will have credible experts come onto their show as guests, and it just provides that foundation that you are really hearing from the expert, hearing a different opinion. If you are at a certain training program or practicing in a certain setting that maybe things are done a little bit differently somewhere else, you get to hear different perspectives on this stuff.

So I think it is a really convenient and interesting way to disseminate information. And as you listen to medical podcasts, and as medical podcasts grow, there are certain niches that can be filled within the community and different people will kind of choose which pieces of information they need from each various podcast platform and episode that you listen to.

Dr. Fumiko Chino: I have really appreciated how we have kind of democratized information. You know, it is Wikipedia, UpToDate, open access articles. You know, it is actually becoming far more accessible to so many more people, not even just people who have to buy the $250 textbook. I love this as a person who never particularly liked reading textbooks.

Dr. Vivek Patel: One thing to kind of go off of that that people think about is social media, right? When you think about disseminating information on social media, it can often be very polarizing. The beauty about podcasts is that you have the ability to explain your thoughts. You are not just making an inflammatory statement that is going to get a bunch of likes. You can really elucidate what you are thinking about. When we think about some of the inflammatory comments that are made about some cancer trials, for example, in the podcast that we have, if you check out The Fellow on Call, we really break down very complicated information, go through every trial, the history of of every trial that has been done in the space, and we will be very critical, but we will be very critical in a very just reasonable way saying, "Here are the limitations." And the ability to be able to explain further in the podcast setting, I think really helps.

Dr. Eleonora Teplinsky: In the manuscript, you talked a lot about the show notes, and I thought that was such a good point, right? It is not just the podcast, it is also what people are taking away in terms of the references and the show notes in there.

Dr. Vivek Patel: That is one of the biggest things that we actually sought to figure out. There has been no study looking at show notes for podcasts and one of the things that you are doing when you are making a podcast episode, you do a lot of research that goes into that for some of these medical podcasts. We made sure to basically show our work, right, and to have all of the links to all of the trials in there. It was a way that we could actually, in the trial, the fellows that were randomized to the podcast arm were really force-fed these links to these show notes. What we saw with our website numbers, we were able to track these things, is that the numbers grew, that we saw more people were using it and continued to come back. So it is just an interesting thing. There is a way that a podcast can have audio components and visual components with show notes and accompanying materials.

Dr. Fumiko Chino: We are tasking trainees to know more and more, right, more and more things in depth, more clinical trials. I always say they cannot eat the whole chicken, they just want the McNuggets. You have managed to make the McNuggets in a palatable format and kind of serve them up so they are easier to absorb, consume, et cetera.

Now I have a slight shift to a more patient-focused question for you, Eleonora. You know, I know that you have witnessed a generational shift in sort of knowledge and communication in patient communities. Personally, I have seen that older patients may be more likely to entirely rely on my recommendation and may feel less comfortable with true shared decision making, whereas younger patients often, quote unquote, "do their own research." They come sometimes with very concrete requests or demands for their treatments. And I would love to see kind of how you have seen it evolve in your clinic, in your online advocacy, and those conversations.

Dr. Eleonora Teplinsky: It is a different time. I love that patients are doing research and that they are advocating for themselves, and it really is that model of shared decision making. But I think some of the challenges that we are facing now is that there are a lot of voices online that are not providing evidence based information. And this is where social media can be challenging because there is no verification of health care credentials. Anyone can call themselves an expert, and we know these algorithms prioritize posts that have likes and engagement even if they are not promoting accurate information based on research and guidelines.

That noise is there. It is hard to drown it out. And so kind of what I think, and I feel strongly that more doctors and health care professionals should be online, we can do our part in promoting the evidence-based information. You know, I am not going to compete with someone who is promoting disinformation, but I think the more we can share credible, evidence information, at least I feel like we are doing our part to empower our patients to listen and to then take those questions to their health care professional.

And I think in a podcast setting, you are right, you can break down the inflammatory posts and the headlines and really dive into it. By having patients share their stories, I think that is really important. Having experts share their experiences, I think that just all goes toward that education and that promoting of accurate information because misinformation is here. And misinformation, you know, partly is always steeped in a little bit of truth in a way, and some people who are saying they believe it.

And so I think it is our responsibility to say, "Here are the trials, here are the studies, here is the data." And then patients are empowered to make their own decision. But you are right, people are coming in and a lot of what they are asking for comes from wanting to take charge of their own health, which I very much respect. But I think the more we can promote the more accurate information, it helps us all. It helps us as a cancer community to provide the best possible care, which is all we are trying to do every day.

Dr. Fumiko Chino: Absolutely. I know that, you know, I have kind of shifted with this idea of like, I want to make sure I am aligned with my patients, even if I do not necessarily agree with what they are asking for or whatever, ivermectin or whatever non-evidence-based treatment for their cancer. You mentioned the spread of misinformation. I know that there was a good trial that Dr. Skyler Johnson did that showed that actually harmful misinformation was more likely to be shared than actual evidence-based medicine, which kind of aligns with that whole idea of the clicks, the increased engagement.

Now, it is often quoted that about 90% of podcasts don't make it past their third episode. You are both busy clinicians, researchers. Producing a podcast is one extra thing that you do in a time when we are all multitasking like crazy. We are increasingly buried in the rising demands of unpaid labor from committee work to peer review. I know I am on a committee with you, Eleonora. So I know that we are both putting in time for that.

What are the benefits for you both of hosting podcasts? How long do you think you can continue on this role? How do you ensure that your content is really meeting the needs of the intended audience? I would love to hear from both of you, but Vivek, go ahead and answer first.

Dr. Vivek Patel: Yeah, so definitely different podcast focus. So from my perspective, you know, one of the reasons why I stayed in academic medicine was to educate. It was really, I love teaching and it is something that was really important to me is helping the next generation of doctors learn, nurse practitioners, PAs, nurses, you know, pharmacists, just everybody. I really just love the idea of medical education and also learning from our other colleagues as well, our other pharmacists and the multidisciplinary team that we have. And the thing that keeps me going with this podcast is that it is a way that I can teach people on an international scale. We never thought that was going to be possible when we started out this thing that we are like, "I do not know, let us just release this to our fellowship." And then it grew into this thing where we have international listeners and you know, we are in over 80 countries and it has been just really lucky for us to have gotten to be able to do this.

So what keeps me going is just hearing from people who listen to our podcast, getting an email from somebody from South Africa who just said, "Hey, that episode that you had with the radiation oncologist," because we do invite guests who are oncologists onto our show and they they can just talk about what that is like. And that is what really keeps me going.

It is a lot of time. Making these episodes is not easy. You know, it is a lot of research, a lot of time and we genuinely love doing it, which is what keeps us going. But it is really just, it is what I wanted to do with my career and it is a way to do it on a much larger scale.

Dr. Fumiko Chino: Right. Eleonora, what are your thoughts about what keeps you going?

Dr. Eleonora Teplinsky: Yeah, I mean I agree, it is a lot of work. I do it all myself, and I will say there are times where other responsibilities have been higher priority, right, so it has taken a little bit of a back seat, but every time I record an episode and have that conversation, I am just reminded about why I love it. Because when I am talking to patients and hearing their stories, I learn something from each conversation, whether I am talking to an expert. So I think it is education for myself, but you are right, you know, as Vivek said, it is anytime a patient comes in and said, "I listened to your episode and, you know what, I felt empowered to go and ask for this for myself," or "I felt comfortable bringing up the conversation," or "I felt like I wasn't alone." You know, someone else was going through that. It just reminds me of it is a resource for people and I think it helps my patients. I kind of view this as an extension of the conversations I have in my office. And I do think too, it is allowed me, and for my patients, I will tell them, go listen to this conversation, listen to this conversation. So I think it has helped me also in a very busy practice be able to- kind of it is like an extension of the patient education piece of it.

Dr. Fumiko Chino: I was going to ask that actually, if you refer back to your own podcast for your patients, because I have certainly said, "Hey, you know, this is a really great podcast about that topic. Go ahead and listen to it if you are so inclined, and we can have a further discussion based on that."

A follow up question for Vivek on that is that have you updated your podcast ever? Like, as for example, knowledge changes, if a study comes out that really is like a paradigm shift. Have you had thoughts about going back and kind of, I know you do typically a series of podcasts on a single topic. Do you want to go back and add like, you know, number four when there were previously just three of, I do not know, early stage breast cancer?

Dr. Vivek Patel: So that is actually the next phase of the podcast. We have a pretty big team that we included really just trainees as the people who work with us because we wanted to also mentor other people through this in research and also in education. And so we are actually actively doing that now. So we are going to have all of these series updated as new information comes. We wanted enough new information to come before we did it. We don't want to just update it really quickly each time, but that is actually what we are doing.

So we have our series built and that data is not going to go away, and the historical perspective matters. We have ways that we are updating these series as well. So that is that is the next phase of the podcast now that we are kind of churning through these deep dives into these cancer topics.

Dr. Fumiko Chino: Fantastic. We have a little bit of time at the end. Is there anything that we did not talk about in this podcast about podcast? Is there anything you want to share in addition? If you want to talk about your favorite podcast that is not your own podcast, feel free. I am a big fan of Sawbones, which is what I like to call, you know, a family medicine doctor reads Wikipedia to her husband.

Dr. Vivek Patel: I will say two things. So one, I think Interlude is an amazing podcast. So if people havn't checked it out, I am definitely going to refer patients to it for sure. I mean, there is there is a lot of really interesting episodes in there. So everybody listening to this, if you are, if you got this far through the episode, definitely check out Interlude for sure. But my favorite kind of fun podcast to listen to now is Good Hang with Amy Poehler. Really, really fun podcast to listen to. It is just, I do not know, it is all these, Michelle Obama was on it earlier, Tina Fey. I mean, it is just so, so fascinating and just like it makes, it is just feel good, a feel good podcast. So highly recommend Good Hang.

Dr. Eleonora Teplinsky: Oh, let's see. So lots of good podcasts. I love yours, obviously, Vivek. That is a great one. But my fun one, I would say I really like How I Built This. It is just entrepreneurs and how they got started, different big companies. I think it is really fun. I have been listening to it for years, and they always have such great people on it.

Dr. Fumiko Chino: Great. Well, we have some homework to do.

I want to thank you both for this great conversation today. Many thanks to doctors Patel and Teplinsky, as well as our listeners. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights you hear from JCO OP's Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you will join us next month for Put Into Practice's next episode. Until then, if you are not already listening to our featured podcasts, The Fellow on Call and Interlude, I strongly encourage you to try them out.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Vivek Patel

Stock and Other Ownership Interests

Company: Doximity

Honoraria

Company: Curio Science

Consulting or Advisory Role

Company: Ipsen

Company: Acrotech Biopharma

Travel, Accommodations, Expenses

Company: Doximity

Eleonora Teplinsky

Honoraria

Company: Sermo

Consulting or Advisory Role

Company: Novartis

Company: Daiichi Sankyo/Astra Zeneca

Company: Pfizer

Company: Immunogen

Company: Novartis

Company: Abbvie

Travel, Accommodations, Expenses

Company: OncLive/MJH Life Sciences

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I am Dr. Fumiko Chino, an Associate Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Care delivery goals for the critically ill, including those with cancer, have shifted towards a patient-centered framework. Advance care planning (ACP) is the process of understanding and sharing personal values, life goals, and medical care preferences so that patient wishes are honored at the end of life. Despite growing evidence of the benefits of these discussions, documentation of advance directives remains low, with some studies showing less than half of people with advanced cancer have a living will or health care power of attorney.

I am happy to welcome a guest today to discuss a new clinical trial evaluating the best way of engaging patients with advance care planning. Dr. Yael Schenker, MD, MAS, FAAHPM, is a Professor of Medicine with tenure and the Director of the Palliative Research Center at the University of Pittsburgh and the UPMC Hillman Cancer Center. She is also a practicing Palliative Medicine Physician at UPMC. Her research focuses on improving quality of life in serious illness with a particular focus on palliative care delivery models. She is the first author of the JCO OP manuscript, "Facilitated Versus Patient-Directed Advance Care Planning Among Patients With Advanced Cancer: A Randomized Clinical Trial," which was published earlier this year.

Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the podcast.

Yael, it's wonderful to speak to you today.

Dr. Yael Schenker: Thank you so much for having me, Fumiko. I am such an admirer of you and your work. It's really an honor to be here.

Dr. Fumiko Chino: I am excited for our discussion.

Do you mind starting us off with just a little history about how you got interested in palliative care and what the field looked like when you were in training and your early career? For example, the term "death panels" from 2009 still really haunts many of us interested in advance care planning.

Dr. Yael Schenker: Yes, that is actually when I started in the field, and I remember those days well. I had a windy path to medicine, and by the time I got to medical school, I was really drawn to taking care of the sickest, most complicated patients. I loved all of the life stuff, the stuff that was not on the diagnosis list but had such an impact on how people navigated a serious illness and what was important to them. I remember going to a funeral in the Western Addition in San Francisco for one of my first primary care patients when I was a resident and just being blown away by this incredible community, this church filled with people, this vibrant life that I had only caught tiny glimpses of in our 15 minute clinic appointments.

I caught the research bug during residency, and I started really thinking about how we were communicating with patients and how we figured out what was important to them. At that time, I was headed towards a career as a primary care doc, but I stayed at UCSF to do a general medicine research fellowship, and I wrote my first grant about serious illness communication to the National Palliative Care Research Center. I got that grant, and I figured if I was going to be a palliative care researcher, I should really be a palliative care physician also. Amazingly, back then, and this was 2010, you could grandfather in and take the palliative care boards without doing a palliative care fellowship. So I did that. I started practicing palliative care clinically, and I really dove into this question of how do we make sure that people have a voice in the care they are receiving near the end of life? And how do we make sure that care aligns with what matters most to them? Those questions have more than filled 15 years as a faculty member at the University of Pittsburgh, and it has been such a joy to watch the field take off and, in the last five years, to lead a research center focused on improving the quality of serious illness care.

Dr. Fumiko Chino: That's a great history. I wanted to ask just a quick follow up question on that. How were we doing this before? Because I know you have spent the last 15 years of your career improving how we do advance care planning conversations and trying to figure out the evidence-based solutions for making change. But how were we doing it before?

Dr. Yael Schenker: Yeah, so advance care planning has an interesting history, dating back to the 1990s and the Patient Self-Determination Act and the sort of requirement that we let people know that they have a right to make decisions about their care. And I think for a long time, we sort of thought of advance care planning as a form, and we would hand people a form and sort of check a box and say that we were done. I think we have done so much since that initial history to really understand what it means to involve people and to give people a voice in their care and to view advance care planning as a process, not a check box.

Dr. Fumiko Chino: That is so helpful, again, to practice truly patient-centered care.

Now, this trial, the "Patient-Centered and Efficacious Advance Care Planning in Cancer," or PEACe, compares the effects of facilitated advance care planning with a trained nurse versus a patient-directed program delivered via a website and written materials. Do you mind giving us an overview of this randomized study and what you found?

Dr. Yael Schenker: Absolutely. And just to note that advance care planning continues to be a source of some confusion, both for clinicians and for the public. So, like we said, advance care planning is defined as the process that supports people to understand and share their personal values, life goals, and preferences for future medical care. And it is now widely recognized as a strategy that improves the patient-centeredness of care. And failure to deliver patient-centered care near the end of life, meaning care that people want, remains a key shortcoming of our cancer care delivery system.

So advance care planning is guideline-recommended for patients with advanced cancer, but there are a lot of different ways to do advance care planning. And these approaches vary quite a bit in terms of cost, complexity, who is involved. So the question that really motivated this study was, which way is best? And like you said, we compared two different ways to do advance care planning: patient-directed advance care planning, in which we gave patients written and web-based tools to complete the steps of advance care planning on their own time, at their own pace, and a more resource intensive approach, facilitated advance care planning, in which patients had structured advance care planning conversations with a trained facilitator.

This was a single blind, patient level, randomized comparative effectiveness trial. We enrolled 400 patients with advanced cancer. Our primary outcome was engagement in advance care planning, which we measured using a validated scale called the ACP Engagement Survey. And I will note that we chose this as our primary outcome because it measures a lot of different advance care planning behaviors, reflecting this updated definition of advance care planning as a complex process rather than just completing a form. And so this scale includes subscales related to self-efficacy or confidence and readiness to do things like choose a decision-maker, talk with your decision-maker about what is important, sign official papers, and talk with your doctor.

And so what did we find? At 12 weeks, patients in the facilitated advance care planning group had higher engagement, and this was a difference that was both statistically and clinically significant in terms of behavior change. They were also more likely to have completed a living will or advance directive at 12 weeks, and this was also a significant difference. 75% of participants in the facilitated group had completed a living will or advance directive at 12 weeks versus 61% in the patient-directed group. And another way to say that is that at 12 weeks, the odds of having a living will or advance directive for patients in the facilitated group were over two times the odds of having a living will or advance directive for patients in the patient-directed group. There were no significant differences between groups in the odds of having an advance care planning conversation with family or friends or with physicians. And, notably, all advance care planning behaviors did increase from baseline in both groups.

Dr. Fumiko Chino: I really love the trial, which is a randomized trial, obviously our highest level of evidence, but also it is a pretty-straightforward trial, which is, if you do not need to use the more resource intensive modality, which is the trained nurse facilitators, if just giving people some information is going to work, then show that. But sadly, no, it really- having a trained facilitator really does seem to increase uptake. So one point that was made in the intro of the study, and I think you just made, which is the field of ACP has moved beyond the sole goal of legalistic forms to encompass several different patient-facing approaches. So again, like what you said, it is beyond just checking a box. The goal of identifying the optimal strategies for facilitating patients to have these important discussions with their families and providers is so important. As you said, there was no difference in the trial groups between discussing with friends and family with their physicians, but there were far higher rates, almost 90%, of having those end of life wishes discussed with families. But actually less than half had this type of discussion with their physicians. So why do you think that is?

Dr. Yael Schenker: Yeah, that is a really important observation. Thank you for bringing it up. It is something we have thought a lot about. And first, I want to say that discussions with family are important in and of themselves. We know that a lot of the work of advance care planning happens at home, outside the medical setting. And we know how important and valuable those discussions with family can be. Earlier in my career, I led some qualitative work interviewing family members who were in the midst of making decisions for a loved one in the ICU. And in those moments, which often involve significant emotional distress or conflict, we heard again and again about the value of being able to think back on those conversations with family and understand what was most important to their loved one. So conversations with family and friends are important.

The second thing I would say is that, yes, conversations with physicians remained relatively infrequent at 12 weeks. Just under 50% reported an ACP conversation with their physician in the facilitated group versus 40% in the patient-directed group. And this is, in some ways, not surprising given that neither intervention included a physician-directed component. So we were not asking oncologists to do anything as part of this study. And I will say, with the caveat being that I am not an oncologist, but there are lots of barriers to having these conversations. The simplest being practical barriers like not having enough time within a standard oncology clinic visit. We also know that many physicians worry that advance care planning conversations will take away a patient's hope. And that is something our research group has also looked at. We actually did not find an association between advance care planning conversations and decreased patient hopes. If anything, these conversations seem to increase patient hopes, but that worry remains. And so I think we have more work to do figuring out how to integrate advance care planning with clinical care. And of course, the holy grail of advance care planning is how do we improve goal concordant care at the end of life? And that is something we are still working on.

Dr. Fumiko Chino: What you said, that the physician logistical barriers, but that also sometimes physicians, us as oncologists, that we have this fear that is actually not founded in reality that somehow we are kind of stripping hope, whereas I agree, I have actually read multiple research output that say these conversations are necessary and they do not squelch the doctor-patient relationship, and they actually help patients actually prepare better for the future.

Now, there were two recent JCO OP articles focused on palliative care and advance care planning. A quality improvement project found that a proactive social work-led initiative did not appear to increase palliative care referrals or ACP documentation in a community out-based clinic. And then a different study, a claims-based analysis compared end of life care for Medicare Advantage versus traditional Medicare, and it found that participants on MA plans were less likely to have an ACP claim despite having generally less intense health care utilization at the end of life. I think both of these studies point to a sort of a larger, more complex environment around optimal end of life care, including the diverse barriers from things like limitations of the provider workload and to health insurance. Do you have a gestalt about how to address these types of system barriers in improving ACP in cancer? Is it a funding problem? Do you think it is a staffing problem? Is it a communication problem, an education problem? Is it all of the above?

Dr. Yael Schenker: I would say yes, and- I think, first, it is so important to have work like the QI project you mentioned looking at these barriers in real clinical contexts, as well as work like the claims analysis you mentioned including patients with different insurance types. The real world is a very complicated place, and what works in a tightly controlled research environment may look very different when you broaden the patient population or when you do not have the same support for the interventionist's time, for example. I think social workers are a great example of this. It is very hard to protect social work time for palliative care interventions. Their time is worth its weight in gold. They are not available in many settings. Historically, they are non-billing providers.

So I think in order to address system barriers, we really need to look at system resources and drill down on implementation challenges. What is available? What are the barriers? Where are the disconnects? Before we sort of throw money or staff at a problem, I think we have to understand the context. And that is where implementation science is so helpful. We have this evidence-based thing that we are not doing. Why not? This is something our team is starting to work on, and I think we are seeing some interesting system-level approaches to facilitate advance care planning being tried at different cancer centers around the country. So that is exciting.

You asked for my gestalt, which is that we need both top down and bottom up strategies. I think top down, system level strategies make advance care planning easier and the default for clinicians. Bottom up strategies give patients and families the tools they need to feel more comfortable having these conversations. So the next step for our team is to identify and prioritize these strategies, and I am very lucky to have some amazing implementation science colleagues to help think through this work.

Dr. Fumiko Chino: In the discussion of your study, you bring up the idea of a stepped care approach to ACP, i.e., doing a less resource intense option first and then advancing to a higher intensity treatment as necessary. And this model was presented at last year's ASCO, published in JAMA. Dr. Temel and her team showed that a stepped palliative care plan led to fewer palliative care visits without diminishing the benefits for patient quality of life. And this method struck me as really feasible for ACP given how your study finds that even though less than half of those in the patient-directed group actually visited the website, those that did spent almost an hour on it. So the ones that actually engaged in the patient-directed, it seemed like they actually used the tool. So I would love your take on that.

Dr. Yael Schenker: Yes, I absolutely agree, and the study you referenced by Jennifer Temel, Joe Greer, and colleagues is an excellent example of a stepped care model that used fewer resources but was non-inferior to a more traditional resource intensive approach. I love that study because I think we have to be thinking about palliative care as a limited resource, and resources for advance care planning are no different. For some patients and families, the opportunity to engage with a high-quality resource like the written and web-based materials from Prepare for Your Care, which is what we used in the patient-directed arm, is an amazing and highly successful approach to advance care planning.

For others, there are just too many barriers to engagement, and the fact that only 43% of participants viewed the website when left to do so on their own in their own homes is telling. I think a facilitator can help overcome those barriers, and we heard a lot about the value of those relationships and the emotional support the facilitator provided. That may be very helpful for a subset of patients. So I think it is always challenging to individualize care, but we are seeing personalized medicine in so many contexts, and I am really excited to see more individualized, strategic, personalized approaches to advance care planning.

Dr. Fumiko Chino: I like the idea that personalized medicine continues through end of life discussions, which is that the approach you use for one person may not work for someone else. And this is what is difficult about all of medicine, right, is that it is not one size fits all, and we really need to be tailoring our approaches and our methods to the patient and the family in front of us. We have really incredible but also expensive new anticancer treatments that are coming on the market, it sounds like every week at this point. And I think the balance is sometimes very challenging to find for our more complex patients with advanced cancer.

Dr. Yael Schenker: It is getting more and more interesting. I think the field of palliative care, the need for palliative care is only growing as people are living longer and longer with advanced cancer or many other kinds of serious illness. So when experts have looked at kind of what is in the syringe of palliative care, it is really about giving people the skills to cope with the uncertainty, the worries of serious illness, helping people to live well. Symptom management is a key part of what we do, but it is also about walking alongside people as prognostic awareness deepens, as priorities shift, being attuned to what people need and what matters most. So it is an absolute privilege to do this work in partnership with oncologists and amidst this rapid proliferation of treatment options you mentioned. One of the things I really love about palliative care is that it is constantly evolving, and I am constantly learning.

Dr. Fumiko Chino: It strikes me that there are so many things that we can do to improve quality and sometimes quantity of life that are beyond just a medication. You know, we just had the CHALLENGE trial which showed that exercise can prolong quantity of life. I know the groundbreaking study with people with lung cancer that palliative care, it seems to extend quantity of life. And so this kind of dual goal of trying to do everything that we can to truly practice patient-centered care is just an excellent framework for improving the quality of care that we provide.

Dr. Yael Schenker: I agree.

Dr. Fumiko Chino: Thank you so much for this great conversation today. Many thanks to both Dr. Schenker as well as our listeners.

You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you will join us next month for Put Into Practice's next episode. Until then, please take care of yourself.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Yael Schenker

Honoraria

Company: UpToDate

Company: Emmi Solutions

TRANSCRIPT

Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Associate Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Our listeners know that financial toxicity is a growing issue which limits access to high quality cancer care. Cancer drug repository programs offer a unique solution to the affordability crisis, connecting patients to free medications while reducing medical waste. Cancer drug repositories collect unused, unexpired, manufacturer sealed cancer medications and redistribute them to those in need.

I'm happy to welcome a guest today to discuss the YesRx program that has saved patients in Michigan over 17 million dollars in the past 2 years. Dr. Emily Mackler, PharmD, BCOP, is the Co-founder and Chief Medical Officer of the YesRx and an Adjunct Clinical Associate Professor at the University of Michigan. Go Blue! She has led the development and implementation of quality improvement programs across the state of Michigan to improve the care of patients with cancer. She is the first author of the JCOP manuscript "Transforming Cancer Drug Access: Insights on Utilization and Clinician Satisfaction in a Statewide Cancer Drug Repository Network," which was simultaneously published with her oral presentation at the 2025 ASCO Quality Care Symposium.

Our full disclosures are available in the transcript of this episode, and we have already agreed to go by our first names for the podcast today.

Emily, it's wonderful to speak to you.

Dr. Emily Mackler: Thank you. It's an honor to be here, and I appreciate the "Go Blue."

Dr. Fumiko Chino: I spent some time in Ann Arbor and have some great love of Michigan. So, and the Mitten State in general.

Dr. Emily Mackler: Wonderful.

Dr. Fumiko Chino: Absolutely. I'm a Midwesterner at heart, so there's deep love.

I love the YesRx program. I think it just makes sense. Do you mind outlining for me just how the program started, what you found in the last two years helping lead it?

Dr. Emily Mackler: I actually love our initiation story to this program in that our legislation in Michigan took effect actually in 2006, and our program, the first repository went live in 2021 in a small community practice in Michigan where the community oncologist came into the pharmacist's office, put a bottle of medication on her desk and said, "This is a Honda Civic. Can you do something with it?" That was really our impetus or kind of the starting point.

We started the network in 2023 because the first three sites in the state that developed their own internal cancer drug repository programs were done as most things are because a need was identified and there was passion about providing this care and resource to patients. And it became more and more evident that the sustainability for those sites was becoming challenged as there was growth. And I think the most important component that brought us together as a network was that not every practice had the resources to house their own repository, therefore further limiting access to those who probably already had it limited.

Dr. Fumiko Chino: I got you. Do you mind just running through some numbers? Because I know, for example, you've had really incredible growth over the last 2 years, starting at 9 participating sites, going to over 100 now, and I know you've helped over 1000 people in Michigan.

Dr. Emily Mackler: We did start with 9 sites, and those were part of three practices across the state. We are now at over 105 sites across Michigan, including tribal health clinics, small community practices. We cover 90% of the counties in the state as far as those counties having leveraged resources to donate medications or having have received medications from the repository. We have received over 28 million dollars worth of eligible cancer medication within the repository and have been able to get out over 18 million dollars to Michigan residents. So over 1500 Michigan residents have received medication at no cost from the cancer drug repository.

Dr. Fumiko Chino: And I know that as part of this manuscript, there were some surveys for the providers who had participated in the network, and it sounds like they were really just overwhelmingly positive. They thought it was easy to participate, they felt like it helped their patients. So just an incredible service.

Dr. Emily Mackler: And I think from that component with the survey, the approach we've taken is a little bit different than perhaps other large drug repository programs in that our goal was really to serve the clinician in the practice, be the physician, the pharmacist helping with access, the nurse. There are many systems in place that cause some fragmentation of care in oncology practice, and they seem to continue. And we really wanted this to be a very easy, quick resource for clinics that filled gaps for them. And so our response rate to the clinic where, if we have a request come in for a medication, we get that back in the hands of the clinic within 1 to 2 days, and they can provide it to their patient at no cost. We really try to make it as easy as possible for them, no paperwork required for them to fill out related to patient need. We just need the patient to say that they do have need or the patient's advocate, be the financial counselor or navigator in the clinic or someone else.

So satisfaction for us was really key to measure and make sure we were following through on what our ultimate goal was, which was really to, again, keep that agency in the clinic, have the information at the ready for the clinicians to not delay treatment any further.

Dr. Fumiko Chino: You mentioned something that led into my next question, which is that we know that sort of, in general, the drug repository programs require medications to be unexpired, in manufacturer sealed packaging, they must be inspected by a pharmacist, and they must be received by patients in financial need. And so my next question was just going to be about, you know, the quality control aspects of it, what type of medications aren't accepted, and then the specific qualifications that patients must meet to kind of demonstrate need. It sounds like at least from that respect, you're really relying on the treating physician and their team to say, "Hey, this person has need," and you don't require additional documentation, which obviously makes it much easier for the clinician. But for some of those other aspects, you know, in terms of what are you accepting, what can you not accept, and what do you do with the things that people send in anyway?

Dr. Emily Mackler: We really follow the legislation within Michigan, which we are so grateful because it was so forward thinking at the time it was approved. We can accept any medications again that are sealed in manufacturer packaging, except for controlled products, so controlled substances are not acceptable. We cannot accept manufacturer enrollment program medications, so things like lenalidomide that require REMS programming are not allowed to be accepted in the repository at this time. And we do need to ensure that the medications are stored at room temperature for us to accept them. Other than that, it's quite open, and the legislation allows us to collect any medications used for the treatment of cancer or to support the cancer patient. So, in addition to cancer medications, we've also collected and been able to distribute to patients antiemetics, DOACs for instance, or other medications may be used to help support the patient during their cancer treatment. So really somewhat broad.

As far as eligibility, our mission is to prioritize patients who are the most vulnerable or in need of therapy. We have not had to develop a tiered system as of yet because we've really been able to keep the inventory to a place where at any point that it's been requested, we've been able to fill the need. There are some scenarios where maybe those medications are difficult to come by, but really nothing where we've had to tier availability.

As far as what we do with medications that are not eligible, if they've come to us and they've been inspected and don't meet our criteria for safety, we have a partnership with a research lab at the University of Michigan called the Sexton Lab, and they study currently approved, FDA approved medications for other indications. That lab looks at those medications to see what else they might be useful for, uses some AI technology, and they actually accept the majority of the medications that we're not able to use for that research purpose.

Dr. Fumiko Chino: That's fantastic. So you're saying that if someone turns in their ondansetron but it's not in a blister pack, or they turn in their oxycodone in the pharmacy bottle, you're still able to upcycle that medication?

Dr. Emily Mackler: Yes, as much as possible. We really try to eliminate any unnecessary medication waste.

Dr. Fumiko Chino: Wonderful.

Dr. Emily Mackler: We really try to eliminate any unnecessary medication waste.

Dr. Fumiko Chino: I was actually really impressed about the rollout of the YesRx program. I know that you had mentioned in the manuscript that it was specifically designed to focus first on supporting the clinics in the communities with the least amount of resources serving the most vulnerable population, and then sort of later phased out to the larger, more resourced areas. And this strategy was done to create an explicitly stated more equitable, effective, and sustainable statewide program. Can you comment on how kind of this worked in practice and what the resources required by the program to keep up the quality as it's grown? Because it sounds like from what you had said initially just like, it became unsustainable with just the three groups doing it initially and had to sort of- had to get more infrastructure.

Dr. Emily Mackler: Yeah, this approach was really important to us, and I think in part from the feedback, again, of these first three sites of what, we spent about 6 months really learning from them: "What if you could wave a magic wand, what would you do with just this kind of programming in general?" The most important component was sharing inventory. And as you can imagine, if you think across an entire state, perhaps what's donated in one area is maybe not needed as much in that area but needed in a different area of the state. And that sharing of inventory really couldn't exist in those first models.

So that was a big priority. The second one was this recognition that the sites that could develop the program had the resources to develop them. And so we really took time and effort in contacting and working with some of the more rural oncology practices with leveraging the physician oncology organizations in the state, the Michigan Society of Hematology Oncology and the Michigan Oncology Quality Consortium, to learn from the members of those organizations how could they take part and how could we serve them best.

The most integral part of us launching that way was an incredibly invested health care partner who donated storage space and pharmacist resource to YesRx, to our statewide network, and with that, we were able to engage sites that couldn't store, couldn't dispense, didn't have pharmacists at their site, but where we could engage them by having the medication sent to the central storage area and that we could have them e-prescribe to that site and we could get the prescriptions right to them. And so that was really our effort and then engaging some of the larger, more resourced practices after that point.

One of the reasons that we provide to the clinic is that we want to make sure that the clinic knows when the patient has their medication in hand. We also are really with the regulatory components of the cancer drug repository program, the patient or whoever collects the medication is required to sign a recipient form. So we want to make sure that they're educated on this medication has been donated and is part of a repository. So that clinic is getting the form signed and sending it back to our central storage site.

Dr. Fumiko Chino: That totally makes sense because the feasibility of doing that remotely is very challenging.

Dr. Emily Mackler: Yes.

Dr. Fumiko Chino: So just moving to talk about the oral anticancer drug specific drug repository programs, I know as of 2024, there are five states that have these oral anticancer drug repository programs, but there's a larger number, 28, who have just the generalized drug repository program. And I actually read a Health Affairs Scholar review, which we'll link to in the notes for this podcast, which I thought was a super helpful guide. And I know you mentioned earlier that Michigan, although the legislation took effect in 2006, the state approved CDR wasn't really implemented until 15 years later. So it sounds like there was a gap there, and I would assume that there was some advocacy required to help kind of fight for the programs. I would love to know if you were involved in any lobbying at the state level to move the program forward because it seemed like there was like a pause there where it just wasn't moved forward.

Dr. Emily Mackler: Not as much on the advocacy component at that point in time, so post-approval, and I really think the delay in our state was related to the effort to get them running and have it be sustainable. I continue to feel that kind of the closed door repositories can be challenging in the long run because the population served is more limited and isn't encompassing necessarily all the residents that could benefit from it.

We have definitely been heavily involved in advocacy since our launch, however, and there are so many different components of this. One is a keen effort for us to be partially funded by the state of Michigan given the care that is provided and the resource for Michiganders across the state. Those efforts are underway. The other aspects are we have been using the program, the legislation now for the last two years, and we have some ideas on optimizing it. There are some components that if revised, we think we could serve more Michigan residents and that the program could perhaps be run smoother in different aspects. And so those efforts will be underway as well. More so advocacy wise and educating, letting legislators know that this has been in law in essence since 2006, and we're really acting on it now and serving their constituents and then how are ways that we can really optimize the programming.

Dr. Fumiko Chino: I know you said in the manuscript that the program was designed to be a short term gap for a one month supply, and really only a handful of people got more than a one month supply if alternative resources weren't in place at that time. So it's clear that the programs like YesRx are a supplement but are not a replacement for the existing financial access programs. And I was just wondering if you thought that there were lessons learned from this program that can make other programs more efficient?

Dr. Emily Mackler: I think without a doubt, the financial access resources could be streamlined. I think anyone you talk to in a clinic and the knowledge of the financial navigators or social workers or pharmacy staff that are working on these programs is so immense, and the amount they have to keep up is incredible. It would be phenomenal if there were a shared application or some component that would really help streamline some of the processes or even identify what is the best option for this patient. Is it perhaps changing their insurance plan versus co-pay assistance or something else? And so I do wish and think that those things could be streamlined. I think coming together and sharing resources for us has been phenomenal. If you think about waste reduction already on the end of reducing waste of medications, that's part of our goal, but we're also reducing waste or redundancies in workforce burden as far as developing policies and procedures, putting together information, networking and making sure communities know about the programming. Those are all resources that would have had to be replicated at each one of these sites that we've been able to streamline. So I do think that could benefit patients and the practices immensely.

I also think on the financial toxicity for patients with cancer, it continues to be a growing problem. When I started practice, I didn't know the term financial toxicity. I don't recall it being used 20 plus years ago. And it's now such a burden. Even delays in starting treatment is something that we've been able to fill gaps for patients, and it has done an immense amount to decrease their anxiety during this journey that they're on. And so it would be nice if other programs could replicate that ease so that patient's emotional burden could be decreased in the process.

Dr. Fumiko Chino: Absolutely. I personally do a lot of research on prior authorization, and even though the patient might ultimately get the medication, that wait for approval can be excruciating, outside of just the fact of not having the medication and therefore not having effective treatment of symptoms or anticancer therapy, but it's the, "I don't know when it's going to be approved. It increases my anxiety." So being able to have that stop gap, one month prescription, I think is such an incredible resource.

Dr. Emily Mackler: We help a lot of patients up front. We also do mid therapy, and the clinical implications of that are, I think, important. If you think about being on treatment and then having a break of 2 weeks or a month that's not intended, not great or not great for outcomes or adherence for sure. And the amount that that happens due to financial reasons is so much more than I even appreciated: changing an insurance plan and waiting for the new one to take effect, foundation support running up, utilizing or using up all the co-pay assistance that was available to them, so many different scenarios. And you really run a risk of some of the clinical outcomes in those situations or hearing patients split their chemotherapy dosing to try to get through those time periods. So those gaps are also gaps that we're able to fill that we feel really grateful for.

Dr. Fumiko Chino: I'm so impressed by this program.

We are wrapping up the podcast, so I just want to leave a little bit of time at the end if there's anything that we missed talking about, if you wanted to talk about, you know, what the future for YesRx is. I know you already mentioned sort of your ongoing advocacy at the state level to bolster support and funding for the program.

Dr. Emily Mackler: I think the only thing that I would like to add is how much we've really had support from partners across the state. And for groups or states or individuals who really want to do something similar or replicate a model, we would love to have those conversations with you and see where legislation is at your point or what kind of resources could you get set up. But we really are grateful for the supports that we've had that have really been mission-aligned with us to try to reach as many patients as we can with these medications and, again, reduce the unnecessary waste.

Dr. Fumiko Chino: Well, on that positive note, and I love the idea that this is the siren call for our fellow oncologists and pharmacists across the United States to sort of replicate this program, I want to thank you so much for this amazing conversation today. Many thanks to both Dr. Mackler as well as our listeners. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, you can catch up on all of the amazing research being presented at the ASCO Quality Care Symposium at www.asco.org/quality.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

TRANSCRIPT

Dr. Fumiko Chino: Hello and welcome to Put Into Practice, the podcast from the JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Germline genetic testing can play an essential role to identify cancer risk, guide treatment directions, and inform screening or preventative strategies for both patients and patient family members. Access to timely and convenient genetic testing can be challenging based on increased indications for testing, larger gene panels, and high numbers of positive tests that are overloading a limited genetics workforce. This is leading to long wait times and widening disparities in access to genetic testing. I'm happy to welcome a guest today to discuss an intervention he helped pilot using non-genetics providers to increase access while maintaining quality.

Dr. Trevor Hoffman, MD, PhD, is an associate professor in clinical medicine at the Kaiser Permanente Bernard J. Tyson School of Medicine and the Regional Chief of Medical Genetics in the Southern California Kaiser Permanente Medical Group. He leads a department of 10 medical geneticists and approximately 40 genetic counselors, serving 5 million Kaiser members in Southern California. He is the first author of a JCO OP manuscript, "Expanding Germline Hereditary Cancer Gene Panel Testing by Non-Genetics Providers," which was published earlier this year.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Trevor, it's wonderful to speak to you today.

Dr. Trevor Hoffman: Thank you so much for inviting me on the pod. I'm really psyched about it.

Dr. Fumiko Chino: Our specific topic today is something that I know you know a lot about, germline genetic testing. Despite broadened eligibility, only a small percentage of people diagnosed with cancer will undergo germline genetic testing, and I'd love your thoughts on the changes in genetic testing over your 20+ year career, and particularly, obviously for our respects, within the cancer patient population. The who, what, when, where, how, and wherefores of genetic testing and how this has evolved as our scientific knowledge has really improved over time.

Dr. Trevor Hoffman: Yeah, it's been a wild ride considering everything I've seen happen in my own field. Back when I started in practice, we were doing like standard karyotypes and maybe sequencing a gene here or there by Sanger sequencing, and testing was cost prohibitive, thousands of dollars. You know, there were gene patents. You know, we were this little hidden department, like in the basement, that hardly anybody knew about, and we liked our little place in anonymity, and it was all good.

Come the genomics revolution and next-generation sequencing, and, you know, all of a sudden you can, in one machine, sequence, you know, billions of letters of genetic code for hundreds of dollars. It was like a paradigm shift caused by technology. So that and the removal of gene patents, we've come, you know, in the ensuing years to hereditary cancer gene tests that's, you name it, depending on whether it's done 20, 30, 40, 70 genes for under $500 in most cases and can be done in a matter of a couple of weeks. That's a bit of a massive change.

In oncology, we've seen that happen in terms of tumor NGS, right? Like, things are changing for all of us rapidly. And so multiply that across every specialty. In my field where we used to own every genetic test, like genetics would kind of order every test and determine who needed testing, that's not going to happen. Like, it's not going to work anymore. So we have to come up with better ways to sort of put it into the hands of people, make it easy, make it appropriate to maintain access. We can't do the white-glove service anymore where we see every single patient and touch every patient.

That's the shortest version of my career in a nutshell. And you're living this too, right? Like many people listening to this podcast train oncology, like tumor NGS didn't exist, you know, and now all of a sudden it's like standard of care in our system. And you know, people have had to just learn by the seat of their pants. And so we're all in this crazy roller coaster together.

Dr. Fumiko Chino: Yeah, it seems like the proliferation of testing and the vitality of the information gained from it, how important it is, it is unsustainable for the genetics workforce to stay in their closed basement system. As a radiation oncologist who lives in a basement, we have enough people in the basement. We're hoping to integrate them a little better into the larger community.

Now, you were the first author of this recent report on the 3-year experience of mainstreaming hereditary cancer gene panel testing at Kaiser Permanente Southern California. Do you mind briefly discussing the background of what led to this project - again, sounds like limited workforce - and what your study team actually did, and then the actual findings?

Dr. Trevor Hoffman: Yeah, I'd love to. So this kind of arose from, and mainstreaming is essentially in the genetics field, we call that like handing a test to a non-genetics provider to order. So that's kind of the term that has been applied to that. And essentially, we have to do that. And so this kind of arose through some personal relationships I had with cancer providers in our system, a couple of whom were down the hall from me. One of them was a GYN ONC provider, and the other was a breast surgeon. And so, I had both our breast surgeon and our GYN ONC doc approached me and say, "You know what? I'm seeing all these women and they have ovarian cancer, or they have breast cancer, and I know I'm doing surgery on these people. They need a hereditary cancer gene test. It's a no-brainer. And so I have to see them. I schedule my surgery. If it's breast cancer, I'm like, I'm not sure what the surgery is, and this woman may be 45, and it's like, well, I don't know what surgery to do, but we schedule a surgery in three weeks. We refer them to genetics. Genetics sees them, schedules an appointment, orders the test, the patient goes to the lab and gets the test." That all sounds great, right? But the patient may be overwhelmed. They may not know the importance of getting that appointment scheduled very quickly.

In our system, we're under a regulatory guideline to see people within two weeks, but in lots of genetics practices out there, there are wait lists that are a year, two years, three years. The patient may not understand why the surgeon wants this result, right? And it's, you know, I listened to your last podcast about parking charges, right, being a barrier. So like, we're putting up all these barriers for patients with cancer, and then if the patient didn't get the test or do it, the surgeon's like, "I've got to cancel my surgery," and they're calling me. And so we kind of were like, "Hey, wait a minute, like, can I just order this myself in the surgery clinic or in the GYN ONC clinic? Because it's making their life easier." So it kind of arose out of one of these rare things in medicine, right? Like a win, win, win. For them it's a win. They need the info quick. They want to schedule their surgery, they want to know what they're doing. For the patient it's a win because then they don't have to make an appointment, pay the parking fee, all the barriers of getting that appointment done. And from our point of view, it's a win because like, I know before that patient walks in the door, I'm ordering that test for a 45-year-old woman with breast cancer, like it's a no-brainer.

The other thing I would say is that from the point of view of the patient, seeing me for like a separate 60-minute appointment to discuss testing in that venue, they've got so many other things on their mind. The ability to hold onto all that information is just limited. So, you know, we see people and we still do in some contexts in these multidisciplinary clinics, but the retention of what I'm telling patients, honestly is low. They're worried they're going to die. They're worried about, "What surgery am I going to have?" "What am I going to do about my job?"

And so we started doing it on a small scale, but the main thing was making it logistically easy for them. That's the key, is making it as simple and efficient as possible. And so for us, that was putting an order in our EMR that was like a couple of clicks. And then taking the worry off their minds that like, they're not going to be stuck like backpedaling and trying to counsel a patient. Like we're going to be there for you to counsel that patient when they're positive, right away. A lot of it's about reassuring and just making it easy and trust. And so like without that, like this never would have happened, you know, everybody would have stayed in their silo.

So out of that, we kind of grew it and we're up now over 20,000 tests that have been ordered by oncology providers, physicians, case manager nurses for our breast cancer coordinators, PAs in some cases, nurse practitioners, all these people are doing this with clear guidelines, right? Like very clear indications for ordering and an assurance that we're going to see the patients who need to be seen.

Dr. Fumiko Chino: Phenomenal program. I mean, to be honest, the waiting when there's more pressing things on your mind, to kind of get this sort of checkbox, "Okay, I'm negative, I'm going to, you know, I have a better clear decision-making chart for the type of surgery is," can be excruciating for both providers and patients. And it's also just wasteful, I think of a lot of people's time. I think you're accurate, which is that the subtleties and the decision-making flowcharts of genetic testing have been somewhat because of broadened eligibility at this point, it's more limited. There's less of the, "Okay, it was a second cousin who had a diagnosis, but we're really not sure if it was actually breast cancer." Like, it's much more of like, "Okay, if you're younger than 50, you qualify for genetic testing."

Dr. Trevor Hoffman: Yeah. And we made the process very simple. Like anyone with breast cancer under 50, anyone with epithelial ovarian cancer, anyone with exocrine pancreatic cancer. So like stuff where, yeah, I agree. The NCCN drives me nuts because every six months they create this like Byzantine-like algorithm of indication. I think it's crazy. I can't keep up with it. So it's not fair to expect someone to climb through all that stuff. Make it simple. And we're in this sort of slow-moving period where we're just moving to universal testing, probably first for everybody who just gets cancer is the next threshold. And even in breast cancer, like the American College of Breast Surgeons says everybody with breast cancer should get hereditary cancer testing, whereas the NCCN isn't quite there, but we're moving towards that. Like everybody who gets cancer gets germline testing. And then shortly after that, we're probably going to be at population screening. It's coming. Will it get there in my career? I bet.

Dr. Fumiko Chino: Now, there were two recent JCO OP articles focused on genetic testing in prostate cancer. There was the "ASCO Guideline Clinical Insights on Germline and Somatic Genomic Testing for Those with Metastatic Prostate Cancer," and then also a qualitative study on patient perspectives and decision-making regarding germline testing. And what kind of struck me about both of these papers was that one, everyone with metastatic prostate cancer now qualifies for germline testing, which was news to me as someone who doesn't treat prostate cancer. But that two, patients really may not view testing as a priority. They may delay or decline testing because of either cancer treatment burden or some of the people had actually already gotten tested in the interviews and had just forgotten they'd even received testing. The studies kind of highlight that implementing germline testing at scale in eligible populations can be really challenging. I know you talked a little bit about trying to dummy-proof and facilitate these easy clicks with the EMR, but can you talk about the specific provider or patient barriers that you've encountered in your practice and outside of the mainstreaming?

Dr. Trevor Hoffman: Well, you can make arguments in a lot of different directions here, right? So the other frustration I didn't bring up at the beginning for our oncologists, GYN ONC surgeons, and breast surgeons was they'd send the patient over to me and they don't know me from a hole in the wall, whereas that surgeon may have saved my life, right? Like I'm going to do what that person says. They'd come and see me or a genetic counselor, and you know, we offer the patient testing and you know, we kind of want them to be able to choose and all that. And then they're sort of like, "Oh, I do- I may- I don't really need this, you know, maybe I do need this, whatever." And so then the patient would like decline it, and that's fine. I don't want to push tests on people, but there's also a patient-provider like thing there when the oncologist or the surgeon or the GYN ONC is recommending or offering a test, that relationship with the patient impacts whether they do it or not. And so that is a barrier.

You know, I honestly see fewer barriers for doing testing in mainstreaming. And honestly, you know, in our system more tests are being now ordered by mainstream providers than by my own department in our system. It actually, it took a couple of years to get there, but we started this in 2021, and we reached a threshold where non-genetics provider test orders actually surpassed our own department about a year ago. And it's been steadily going up. So I honestly feel like there's fewer barriers when mainstreaming is employed than not. Now, do all patients get the same level of pre-test counseling? No, they don't. And I think we just have to make rational choices and understand that like we can do things one way and not reach a fraction because we know 80% of the people with BRCA1 and 2 aren't diagnosed. So like we have to make some choices. I think on the balance, I favor access over not. So I don't see a lot of barriers.

Now, are we doing other things to try and find these patients out there without looking in the people, the population with cancer? Sure. We know again, we know population level screening is coming. And so we're piloting some things like an email questionnaire that's being sent to Kaiser members where they're asked a series of questions about their family history of cancer. And without ever talking to a human, answers to those various questions can generate a hereditary cancer gene panel order that then the patient goes and gets, and they never talk to a person when that happens. It's all through an online thing, and we see the positive patients in that setting to counsel them. And the patients who have negative results or VUSs, get some information about what that means and doesn't mean, and we can always talk to them, they're able to call us. But we know this time is coming and change is coming, so we're trying to like grapple with like how that's going to happen.

Dr. Fumiko Chino: You mentioned VUSs and that's actually my next question because the VUS is like the thyroid nodule, the bane of my existence.

Dr. Trevor Hoffman: The lung nodule, sure.

Dr. Fumiko Chino: Yes, the lung nodule, the thyroid nodule, exactly. And with the rise of these germline testings, we're just seeing so many increased diagnoses of VUSs, the 'variant of unknown significance'. Your study found that they were two times more common than an actual pathologic or likely pathologic variant, again, that's consistent with what I've kind of seen before. And about one-third of people who were tested actually had at least one. I noticed that in your study, the VUS result actually triggered one of the automatic patient emails, there was a VUS-specific messaging content, there was a chatbot link and results, but it didn't automatically shepherd you to have a conversation with a counselor. And I've certainly had in my own clinic some kind of difficult discussions with patients because VUS, like we don't know what we should do, it doesn't necessarily change our management, but it's not very satisfying, especially if it's in one of those kind of high-value genes.

What's your approach to explaining VUSs? How many people on the study - I noticed that they could request a visit with a genetic counselor - did you have a lot of discussions about VUSs based on this mainstream testing?

Dr. Trevor Hoffman: I'm going to just comment on something you said in the question, which is like, we don't really know what to do with these. And I'll be honest with you, like, I don't either, right? Like I don't have any magic. There's no curtain to pull back, like, you know, and the Wizard of Oz. So I think VUSs are a problem for everybody. Again, we just have to make choices here, I think. At the end of the day, we're not tracking this as a data metric. We aren't getting tons of consults, given the number of tests that we're doing. We're not getting tons of requests by patients or providers to do a consult specifically for a VUS. But again, at the end of the day, like I'm not going to be able to change that variant classification, and you truly shouldn't be using VUSs to make decisions. That's just the truth. You really should be using things like other factors. And again, nothing provides certainty, right? So is the family history consistent with a hereditary condition? Is the patient's personal history or tumor type strongly suggestive of that? You've just got to make the best decision you can. And when we rolled this out, we said, "Look, we're happy to take a consult if you if you want." And again, I understand like from people that look at this, there are suspicious VUSs and there are like ones that are completely can be written off right away. And those are tough. So we always, and we told people all the way like if you're not comfortable explaining this or the patient's asking you a million questions, we're happy to see that patient. It's not a huge uptake.

And honestly, at the end of the day, like VUSs are just right now going to be with us for a while. And again, I'd rather diagnose a ton of patients that have a known pathogenic variant than spend that limited amount of patient hours we have talking to a patient with a VUS. Yeah, a third of all patients have a VUS. Most VUSs are probably normal human variation. The reclassifications that we get, you know, 90, 95% go to likely benign, maybe 5 to 10% are so-called upgraded to pathogenic. If you ask me how many VUSs are in your genome, it's tens if not hundreds of thousands of VUSs, depending on what we're sequencing, right? If we're sequencing exons, it's probably thousands, tens of thousands. If we're looking at everything, it's hundreds of thousands, right? So we're dealing with a little bit of difficulty with human nature, which is when we see something like put on a report, we have this immediate inability to ignore it. I don't have any magic answers, but a lot of the time, these are just me or whomever explaining that we really don't know what this means. For some people that's helpful, and for some people it's just kind of like, "Why did I do this for?" - the patient side.

Dr. Fumiko Chino: Now in the context of a robust family history, early-onset breast cancer, multiple family members, obviously it takes on more meaning than if it's just a regular … you know, postmenopausal breast cancer happens to be triple negative, and that's why they, you know, triggered the genetic testing. And so I 100% agree. It shouldn't be the thing that drives decision-making. It doesn't supersede something like a robust family history.

Dr. Trevor Hoffman: We haven't had a lot of issues come up around that with our providers or our patients. You know, I'd say the biggest concern of like the mainstream doctors was they were worried about like GINA, the Genetic Information Nondiscrimination Act. And I'm like, "People, come on, this person has cancer, right? Like their life insurance is not going to change if they have a hereditary cancer result that's positive or a VUS or whatever, like they have breast cancer. Their insurability for life is probably not going to change." So, and we spent decades telling people, "Oh, you can't do this, right? Like you're not capable of doing it. We have to do this, right?" And so it's, it's also about like, that's kind of old thinking and times have changed, and we've got to do things differently.

Dr. Fumiko Chino: Provider education is so important because 100% like I was told you don't order your own genetic testing. It's, you have to go through the official route. And then that meant intrinsically in my mind, "Okay, that's a delay I need to build into my treatment plan." As a radiation oncologist, again usually people who are referred for testing already have it before they meet me, but sometimes you'll just someone will slip through and you're like, "Okay, we need to wait and not start anything until we get the results of this." So it definitely still happens.

I was struck by the findings on the study that 10% of the group who had positive results, which was about over 100 patients, through the mainstream testing did not actually end up meeting with the genetics team to discuss the results. And this was compared to 0% of the people who initially met with the genetics providers that had positive results. None of them skipped counseling. So can you speak to kind of how you think this occurred, what the potential solutions you might consider for this gap in the future from your team?

Dr. Trevor Hoffman: Yeah, so I'm going to pat myself and my department on the back because we saw 100% of the patients that we diagnosed with, I'm just kidding. But no, you know, 10% you could say, "Oh my gosh, that's awful. Those patients never got counseling. That's a horror show." For this paper, I looked in the chart of every single one of those patients that we didn't see just because I was curious and wanted to know like why was this? Like what was the barrier? Why weren't they coming to see us? And, you know, in our system, we offer everybody a phone appointment. They do not need to come in. So we can call anybody on the phone and do anything over the phone.

You know, so we looked at things like was the patient like super sick? Were they on hospice or palliative care? Were they too sick to just have the visit? And honestly, it didn't seem like that was a strong correlation. I would say for many of the patients, and I don't have a specific number, but there were a lot a lot, a lot of the patients that we never saw who when you looked at the documentation, they'd been told the result and actually counseled by their cancer provider. That speaks to just that, you know, there are and and again, as we all learn, right, in this genomics precision medicine revolution, I looked in some of these charts and said, "You know, I can see why the patient didn't want to come see me because the oncologist clearly documented like a whole counseling session, information given. We're not asking them to do that, but they did it, right?" And then the patient felt like, "What do I need out of this, right?" And so that was definitely a substantial fraction.

There was another fraction, I think, and we didn't specifically study this, but I think people have different, like I said, motivations for doing testing. It may be being pitched to them as like, "Hey, we need to know this for your treatment. You know, it may be that has to do with like a PARP inhibitor or whatever." And so they may not really have at the top of their agenda like counseling family members. Maybe they don't have kids. There were some instances where patients refused an appointment, but we couldn't always figure out why, but that's definitely, that's some of it. And then yeah, I mean, there were probably were some people who, you know, had too much in their mind, they were too sick, whatever. And so we, we definitely after seeing that have come up with ways of, you know, if a patient refuses an appointment with our department, we're going to send them a written counseling basically to their home address. Like, "Hey, this is your result. You know, you have a hereditary cancer condition. This is some information about it. You know, and if you do want to talk to us or your family members want to talk to us, call us," to sort of like augment that space where we're just like maybe not sure what's going on.

But I will say I was kind of almost reassured in a good way because I do feel like there were some people out there who were just kind of doing counseling that was satisfactory to the patient, I think, and seemed very reasonable. And so I still think at the end of the day, it's probably better for that person to have had that test, gotten the result, gotten the care informed by that result and not talked to us than not doing any of it.

Dr. Fumiko Chino: And definitely seen, you know, like siblings who are like, mom was BRCA positive, sister's BRCA positive, the last female member was tested because of their breast cancer and they just, we just need to check off the box so we know they're going to get the PARP inhibitor, and it was sort of the necessary prolonged hour-long genetics conversation may be of less benefit for them. Again, in the old days, I feel like when we were very territorial about our specialties, I think that could have led to some conflict, but it sounds like, again, the genetics team is just in general like information wants to be free. If you have a direct need for counseling your patients on the specific thing, that's also potentially totally adequate and appropriate.

Dr. Trevor Hoffman: We're hoping with everything we're doing that the information's getting to the patient and the family members. The number of patients in that 10% that I think were unaware of their result is probably a tiny, tiny number of people.

Dr. Fumiko Chino: Now, an earlier study you conducted found that variants identified on tumor-based DNA sequencing could trigger germline testing and thus serve as an opportunity to diagnose hereditary cancer. This study that you pointed out to me was published in 2022 in Familial Cancer and showed that a universal tumor DNA safety net screen, is what it was called, could be an important strategy augmenting traditional genetic counseling. So in this study of the newly diagnosed people via the safety net, about a third had a pathogenic or a likely pathogenic mutation, and intriguingly enough to me, two-thirds of those people wouldn't have met NCCN testing guidelines. So this sort of like- the tumor can point the way. How do you think that these study findings should help inform providers trying to navigate this sort of genomic universe?

Dr. Trevor Hoffman: Right. So we're talking about like clinical things that generate a germline test, right? Woman under 50 with breast cancer, boom, order the test, right? And again, all of this is around like diagnosing people, getting the test and diagnosing the undiagnosed. So, we recognized once all this tumor NGS started launching that like there were all these people floating around that had, "Oh, guy with lung cancer and he has a tumor variant in BRCA1. Woman with brain cancer, tumor variant BRCA2." And a lot of those patients were just kind of like floating out there. We'd get the occasional referral asking about it, you know, that kind of thing. And so, fortunately again, at Kaiser everything is under one roof. And so, you know, all our tumor NGS results were basically being stored in a, in a research database essentially. And so we started pulling tumor variants, this is a couple of years ago now, just to see what's in here. You know, like how many patients are floating around in this, have we tested them, have we not? And so, we started pulling all the BRCA1, all the BRCA2, all the Lynch syndrome genes. And we're up to about 10 genes now that we're kind of like across the board, anybody that has a tumor variant in those genes, like we are basically reaching out to those patients and saying, "Hey, there's probably a 40, 50% likelihood." So, and again, back to BRCA1 and 2, you know, about half of those tumor variants were germline. Didn't matter what the family history.

And like you said, a lot of the patients who had a germline BRCA1 or 2 and a mutation in their tumor, like didn't have a tumor that would like, and sometimes not even a family history, that would suggest that this problem ran in their families. And that has to do with like people in Southern California may not know their family history. Their entire family may be living in a different country, all these things, or they just may be unlucky. They may have just gotten lung cancer and have this too. So, yeah, we started a project and are continuing that. And again, some systems have Lynch syndrome screens for mismatch repair immunocytochemistry. We've expanded that to a molecular screen for tumors. It's another way we're diagnosing the undiagnosed in this area. So we aren't doing it for every single hereditary cancer gene. So like TP53 is the classic gene that's like mutated in all these people's tumors and almost never is that germline. But for things like BRCA1 and 2, Lynch syndrome, a lot of the breast and ovarian cancer susceptibility genes, the likelihood of if you see that in a tumor and the variant allele frequency is anywhere between 30 and 70%, there's probably a roughly 50% chance that that is a germline mutation, we should be looking at that.

The unfortunate thing is when we first started this, it was sad, but there were some patients that had died. You know, and I called some families where, you know, someone had died and said, "Look, your loved one had a mutation in their brain cancer of BRCA1." I didn't have a single person scream at me. Most of the time they were like, "Thank you for calling me." And sometimes it was like, "Oh yeah, well, that explains why his sister had breast cancer at 35 and, you know, blah, blah, blah." So, now it's more real-time. So, you know, we're doing that test in our own lab, and so every week, as they find these mutations in tumors, we get handed a list, we call the patient, and offer them a test. So we have to come up with better ways of diagnosing all these people because we're not doing a good job, and that's just another tool in the toolbox that we've applied at Kaiser to do that. And other systems, I'm not- this is being done in other places. I'd imagine your institution, there's probably some movement or process to do this too, would be my guess.

Dr. Fumiko Chino: I think our classic paradigms of screening and referral have definitely fallen down in this kind of new era of proliferation of germline testing.

We are wrapping up the podcast. I want to leave just a little bit of time at the end. Is there anything that we missed covering? We haven't even talked about direct-to-consumer testing and the 23andMe of it all. Happy to have any last thoughts for you before we wrap up.

Dr. Trevor Hoffman: Yeah, it's a crazy world out there. I've been talking a lot about access. It used to be that you could just immediately swat away any direct-to-consumer testing as like bogus or not accurate, and, you know, 23andMe, I'm dancing on the grave of their bankruptcy, but that's not true anymore. And it's good. At the end of the day, it's good. I think the direct-to-consumer testing being done by the good people, if you want to call it that, you know, the Color Genomics, the Invitaes, you know, where they have true counseling abilities as part of what they're offering people, I think is good. And we do see some patients come in who've done a direct-to-consumer test. It's really hard now because it's like you can't just blow everything off, and that's making it hard for us, for primary care doctors, you name it. And so, yeah, it's a crazy world out there.

Dr. Fumiko Chino: Seems like the Wild Wild West in some respects.

Dr. Trevor Hoffman: Yes.

Dr. Fumiko Chino: Well, I really appreciate you, you know, for this great conversation today. I want to thank you, Dr. Hoffman, as well as our listeners for tuning in. You can find the links to the papers that we discussed in the transcript of this episode.

Dr. Trevor Hoffman: Thank you so much.

Dr. Fumiko Chino: If you value the insights that you hear on the JCO OP Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode. Until then, please stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Employment

Company: MD Anderson Cancer Center 

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Trevor Hoffman

No Relationships to Disclose

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast from the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center, with a research focus on access, affordability, and equity.

An estimated 85,000 adolescents and young adults (AYAs) between the age of 15 and 39 will be diagnosed with cancer in the United States this year. Although this accounts for less than 5% of all cancers, AYA cancers have been rising over the past decade, and AYA survivors have unique survivorship needs, including physical, emotional, social, and spiritual communication.

A recent paper published in JCO OP titled "Promoting Resilience and Stress Management: A Randomized Control Trial of a Novel Psychosocial Intervention for Adolescents and Young Adults With Advanced Cancer" detailed the findings of a clinical trial testing a skills-based coaching program with the goal of decreasing psychological distress and improving quality of life.

I'm excited to welcome two guests to the podcast today to discuss optimal care for the AYA population. Dr. Abby Rosenberg, MD, MS, MA, is the Chief of Pediatric Palliative Care at the Dana-Farber Cancer Institute, Director of Pediatric Palliative Care, Boston Children's Hospital, and an Associate Professor of Pediatrics, Harvard Medical School. She is also the current designated pediatric oncologist at the ASCO Board of Directors. Both Dr. Rosenberg's clinical approach and her research focus on helping patients facing critical illness live their best lives and for as long as possible. Specifically, she and her team develop programs that help patients and families build resilience and optimize quality of life. She is the first author of the published trial we will be discussing today.

Dr. Lauren Ghazal, PhD, FNP-BC, is an Assistant Professor and researcher at the University of Rochester School of Nursing. As an AYA cancer survivor herself and a family nurse practitioner with a background in economics, she brings a unique perspective to cancer care delivery research. Dr. Ghazal completed a postdoctoral research fellowship at the University of Michigan on an NCI T32 in cancer care delivery after earning her PhD at NYU, where her dissertation focused on work-related challenges and financial toxicity in AYAs.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Abby and Lauren, it's wonderful to speak to you.

Dr. Abby Rosenberg: Thanks for having us. We're so happy to be here.

Dr. Lauren Ghazal: Yes, thank you for having us.

Dr. Fumiko Chino: Our specific topic today is: improving outcomes for the AYA population. Abby, do you mind starting us off by sharing some background on this trial and giving us a brief overview of the study and your findings?

Dr. Abby Rosenberg: Yeah, I'm happy to. And thanks again for having us.

You mentioned, Fumiko, the prevalence and problems that adolescents and young adults with cancer often have. One of the things that I like to point out is we know that if you're diagnosed with cancer as an adolescent or a young adult, you have higher risks of poor psychosocial outcomes forevermore compared to younger pediatric or older adult counterparts. With that in mind, we have been thinking for a long time about: how do you promote well-being and resilience in this particular population?

One of the things that we also know is that adolescents and young adults with advanced cancers, those that have recurred or progressed through initial treatment, not only tend to be less engaged with a lot of the really important conversations that we have in healthcare, but later on, especially if their time becomes short, they tend to regret that disengagement. And so what we had done in our previous research is we had created this program called PRISM, and that stands for Promoting Resilience in Stress Management. And PRISM was a peer-to-peer–based coaching program designed by our team in partnership with AYAs for AYAs, specifically to help them navigate these stressors. And what it does is it leverages simple, reproducible, evidence-based what we call 'resilience skills'. And these are things like skills in stress management, setting goals, cognitive reframing - that's how you appraise a situation - and then benefit-finding or meaning-making. And our prior randomized trial suggested that PRISM compared to usual care amongst adolescents and young adults with early-diagnosed cancers improved their resilience and their hope and their quality of life, and it reduced their psychological distress.

In those studies, teens and young adults who had advanced cancers said, "Hey, you know what? These skills really helped me navigate this first experience, and now that my cancer has come back, what I really need help with is applying these skills to these really hard conversations I'm having with my medical team and with my family." So the current study that you are talking about today really tried to ask the question of: could we combine our previous PRISM projects with some integrated advanced care planning communication skills for AYAs with advanced cancer? And if we did that, could we improve some of these important outcomes?

And so what we did was we randomly assigned 144 adolescents and young adults with advanced cancer to either PRISM or usual care. In this study, PRISM included those same four skills - stress management, goal setting, cognitive reframing, and benefit-finding - plus an optional component where they could engage in formal advanced care planning skills. And then we saw what we got at 3, 6, 9, and 12 months. Amongst the 144 people who enrolled, their average age was about 16 and a half years, and they were half-half male and female.

Within the first 3 months, the people who got usual care, not PRISM, did better with their quality of life. It's not what you want to see as an investigator. But the people who got PRISM did better with their hope and their resilience skills. And then I think what was more important is over time, the improvements in the usual care arm, they weren't sustained. And in fact, the people who got usual care instead of PRISM tended to kind of bounce all over the place with their psychosocial well-being. There was really no predictability, and on average, they did worse over time. But on the other hand, people who got PRISM not only immediately improved that resilience and hope at 3 months, but then they had sustained and continuous improvements in quality of life and distress. They were more engaged in things like advanced care planning and conversations with their doctors and nurses over time. And the overall suggestion of those data is that building skills and resilience and hope early on can lead to lasting improvements in overall well-being.

Dr. Fumiko Chino: That is a fantastic overview of the trial, and again, I love this concept of building from within, you know, what started with a peer-to-peer type program and realizing that these skills are so helpful to people going through any kind of critical illness.

Now, Lauren, I'd love your take on why this type of study is important, why interventions in the AYA space can be so challenging to develop and test. So, for example, in this trial, one-third of the intervention group discontinued sessions because they were either too busy or too sick.

Dr. Lauren Ghazal: Yes. And thanks again, Fumiko, for the introduction and for having me here. As you mentioned in my introduction, I'm an AYA. I was diagnosed at 26 with stage 2 Hodgkin lymphoma. And as many of us AYAs in the advocacy space, as you know, at the time of diagnosis, I was doing far more important things in my life than wanting to worry about and deal with cancer. And so when cancer came very dramatically into my life, I had to tackle it with whatever, as Abby said, resiliency skills and resilient skills that I had built up to that point. I was 26, so 10 years over the median age of Abby's study, but that's what I was left with at the time to deal with my diagnosis and my survivorship. So I was also working as a family nurse practitioner in primary care, and I was also in my first year of a PhD program in nursing research. So I had caught that nursing bug to be a researcher really early on in my clinical training. And I remember seeing this paper come across my inbox a few months back, and I was so excited to read this publication. As an AYA, I'm always like selfishly so grateful to see work being done in studying resiliency and stress management and overall quality of life because I feel like I'm constantly kind of suffering with that and really trying to understand kind of how do I separate my AYA advocacy role and my personal experience in this work, and then also as a researcher in the AYA world.

And so, yes, very excited to see this study. And we all know AYAs face these unique challenges, challenges that include high symptom burden, developmental transitions, these competing life demands that can make participation in research particularly complex. I know firsthand how overwhelming having a cancer diagnosis can be during this life stage that's already filled with so much uncertainty. And so when you're straddling again this independence-dependence as an AYA, for me again, just beginning graduate training and trying to make sense of who I was, who I was becoming, all of these competing demands that can complicate not only how we experience care, but how we also engage with research.

So I think when I think about Abby's study too and something that you had mentioned in the overview is really like the time investment of putting up this hard work up front of building the resilient skills that maybe you didn't see it within the first 3 months compared to usual care, but later on in the 6- and 12-month time point, that's so critical to promoting resilience and sustaining that resilience not only throughout the rest of your survivorship and navigating, you know, your healthcare engagement, but also your overall life skills too.

And so I don't think you even know this, Fumiko, for as well as you know me, that I actually participated in another clinical trial on resilience and stress management. And this was 5 years ago now. And I actually pulled out the toolkit that we were given really early on this year when there was a lot of other stressor trigger points in my life, and I did one of the activities, and it was really just on targeting the trigger points, the stress points, and then trying to kind of address what I had control over in that moment, right, what was out of my control. And so that's 5 years. We know that we have not a lot of funding available that we can study AYAs for 5 years in these clinical trials, but they're skills that are really that you're using for the rest of your life. And so being able to capture that, I think is just so important. That was one thing I wanted to take home here was that I used those skills that I learned 6, 7 years out from that trial.

Dr. Fumiko Chino: I was going to ask you a follow-up question to see if anyone had ever actually tried to develop coping skills for you as part of your standard of care, and it sounds like as part of a clinical trial, actually, you did get some of those, that development of those skills, and they're still paying off for you 5 years later, which is phenomenal. And I think we'll see potentially people on Abby's trial still benefiting in survivorship, be that as it may, in years if they get to that point, which is, you know, again, the whole goal of trying to think about resilience and building hope and sustainable interventions.

Now, this study was really focused on patients in the early adolescent and young adult ages 12 to 24 on the trial and was recruited from the children's hospital pediatric cancer departments. Abby, as part of your clinical experience as a pediatrician, what are the potential differences in the cares and needs of the younger versus the older AYA population? From my own experience, I can give you an example. I remember when my husband was diagnosed with cancer in his 20s, one of his team members referred to him as, quote unquote, "basically a pediatric case." It kind of hit me sideways at the time, but in hindsight, I can actually understand how being treated in the pediatrics department could have had some unique advantages, especially with wrap-around services at the end of life.

Dr. Abby Rosenberg: I so appreciate that question, Fumiko, and I feel like I first want to apologize on behalf of all oncologists for the way that your husband received or heard those words because I think the beauty of AYA oncology is that we really want to find the right place for people. And the way we balance it, before I answer your question, is I think there's two domains that people think about. One is what kind of cancer does this person have? Because there are a lot of, quote, "pediatric" types of tumors, and those types of biologies, those types of cancers are things that adult medical oncologists just may be less familiar with and we pediatric oncologists know how to treat really well and vice versa. So like if a young woman came into my clinic with breast cancer, I would be like, "Yeah, we don't do that in peds, you need to go across the street to the medical oncologists." If the goal is, we need the best oncologist to treat and hopefully cure you of your disease, then that's decision point number one. Decision point two is: what is the developmental and psychosocial place that you are in in your life? And so similarly, you know, AYAs are defined by the National Cancer Institute from people between the ages of 15 and 39, and that is an enormous developmental age spectrum. And my 15-year-old patients are really different than the 35-year-olds across the street. And so what we think about in this sort of triaging of where people should go is are you still living with your parents? Who are your decision-makers? In pediatrics, we are inherently family-centered. Like, we do not ever make decisions in isolation with patients, at least I should say very rarely. It's always understanding that they are in a dynamic of relationships and other caregivers and loved ones. And that's somewhat different in adult cancer centers where the patient can have a lot of private conversations with or without their caregivers.

The other thing we think about a lot in pediatrics is people are still developing in their autonomy, their identity, many people are still on their parents' insurance, many people need caregiving support full-time, and it's different from if you're an independent young adult. And so we sort of think about how do we provide all of the services that you need.

You mentioned wrap-around services. So now I get to stand on my 'pediatrics is better' soapbox. We in pediatrics practice these holistic ways of approaching healthcare in general. So in most pediatric places, every person with cancer has an assigned social worker. They often have access to things like psychology and child life and music therapy and art therapy and school rehab, and there's schools embedded within the children's hospitals and all the things that you can think of to try to maintain your life track as best we can while you're going through all the stressors of cancer. As you said, I'm a pediatrician, I'm a pediatric oncologist. My focus has been in AYA oncology, but in the pediatric space, and we thought about, should we also enroll people who are in the adult medical oncology centers, and we realized that that quote "usual care" would be so different between groups depending on where people were receiving their oncology care that we just decided for the rigor of the science to focus on pediatric centers. And I think what's kind of cool about that is if you imagine usual care in pediatrics is pretty high bar, like you get a lot. If PRISM is still better, that says something about what we are missing even in pediatric oncology care, let alone what the rest of the oncology treatment centers might be missing too.

Dr. Fumiko Chino: Absolutely, absolutely. And again, not to dog on adult cancer services or to speak the benefits of pediatrics, but I definitely see that gap certainly in my own clinic and from my own lived experience.

Now, Lauren, I have certainly heard from other AYA survivors in their 20s and 30s that they felt that sort of they were between worlds during their cancer treatment and just survivorship. Many have to maybe even move back home or they might need family caregivers during their treatment, and this can cause really a disconnect in identity that can also add to stress and anxiety. In your opinion, how can we be supporting AYA survivors' psychosocial needs better?

Dr. Lauren Ghazal: Yeah, that's the million-dollar question. And I want to preface this by saying that it's so difficult to speak on behalf of all AYAs, and I can never do that. And I say this a lot, but we know this, the NCI, ACS knows, the one-size-fits-all for survivorship model does not work, especially for AYAs, and Abby alluded to this very wide age range that we see in AYA cancer survivorship. I think that there are really great programs across the nation that standardize AYA formal programs that are being designed, that are being implemented across the many different areas of AYA survivorship that Abby had mentioned including financial navigation, getting financial services, psychosocial support, embedding psych and mental health therapy into those survivorship programs as well because those are the biggest barriers for AYAs is being able to access mental health providers that are trained in seeing AYA patients. And for many AYAs, I've been hearing more and more from friends of mine that they had to transition to a new mental health provider, which we know is so difficult during that period of diagnosis.

I would also say too that there's a lot of research being done at UNC in their, the University of North Carolina Chapel Hill, in their AYA program in implementing their AYA Needs Assessment or their Bridge that Dr. Emily Haines has developed, and I know they're undergoing a bit more testing too in shortening that. But when I look at that too and I see all of the different areas that AYAs endorse as these top unmet needs and then really being able to screen and identify in one place that, "Okay, there's more support needed here." That's when then there can be tailoring done. But to actually centrally funnel in through a standardized assessment that can be implemented, and then also recognizing that not every cancer program and AYA program across the nation has every answer and every resource available. And so being able to say, "Okay, we have these formal connections not only with a local AYA organization but also nationally through incredible organizations like Triage Cancer and Cancer and Careers or through the Cancer Support Network." Those have been areas that I've, you know, have really tried to push for is really strengthening referrals to address the health-related social needs of AYAs more formally through community-based organizations and then also streamlining a needs assessment for AYAs.

Dr. Fumiko Chino: I often think about the challenge for someone who potentially could travel or maybe should travel to receive specialty care at these large centers that have so many resources versus staying closer to home where they have more support, where it is a lower cost, right? And trying to figure out what's really worth it. And I think you brought up a really good point, which is that there are national community-based services that are available to everyone. You don't have to go to an MD Anderson or a Dana-Farber to receive them necessarily as long as people are properly plugged into those services.

Now, this trial enrolled AYA patients with advanced cancer. I know Abby, you already spoke to this a little bit, but one of the goals was to increase AYA engagement in goals of care and formal advanced care planning. And I was saddened but not shocked to see that less than 10% of patients in either arm had formal documentation of advance directives in their chart. This certainly aligns with my own experience, not to make this all about me, but, you know, I had a very traumatic conversation in a hallway outside of an ICU about intubation for my husband. And this paper really puts it quite eloquently, stating that even though the intervention may have, quote unquote, "enabled AYAs to engage", it did not help oncologists do the same necessarily. Abby, I would appreciate your insight into the barriers that oncologists may have about starting some of these hard conversations, particularly with younger patients.

Dr. Abby Rosenberg: First of all, again, I'm going to apologize on behalf of all healthcare providers for the non-ideal ways that you guys were hearing serious news. Now I'm going to put on my oncologist hat and say, there's a couple things that I think explain these data. The first is, we oncologists love our patients. We want to fix this problem. We want to cure the cancer. We have the same hopes and prayers that so many of our patients and families do, and so I think there is this real sense of failure when we see the beginnings of treatment not working, and I think oncologists and patients will align together to keep fighting as long as they can.

What we found in this study, we measured engagement in a lot of different ways and we saw that AYAs who received the PRISM program were more likely to directly engage in conversations that we would extract from like medical records, like sort of text notes about what conversations were happening in the room. They were more likely to ask direct questions and respond directly to palliative care consultation when palliative care teams were having sort of really hard conversations about prognosis and goals of care and what matters to you given what is happening. But the next step, as you're describing, is the formal documentation of something like an advance directive and the formal documentation of, "What would I want if I can't speak for myself?"

So there's a couple sort of last things that I'll say that I think explain why we didn't see any difference in uptake of those advance directives in our study. One is, we had younger people. So 16 and a half, those young folks don't complete their own advance directives. They can complete a document called "Voicing My CHOiCES" which talks about what they would hypothetically want, but that is another sort of formal documentation that I think a lot of people might have felt like, "I'm not going to engage in that," or the oncologist wouldn't have offered it because they were talking to the parents or it was too scary or too hard for these young people who were still not of the age of majority making their own decisions, number one.

And number two is, I think we really try to avoid, not for the right reasons, but I think oncologists in general with well intentions try to avoid those hard conversations because they worry that we will cause harm, we will cause pain, we will, quote, "take away hope". And this is where I and probably many other folks in palliative and supportive oncology struggle because we know that patients and families have those things on their minds. We know that inviting the conversation doesn't in fact take away their hope, it helps them really make more precise the things that they are hoping for and enable them to achieve the goals that they can realistically achieve, especially if time is short. And I think in this study, maybe the first obstacle was: will AYAs engage? We found the answer is 'yes'. And so now the second obstacle is, how do we enable the oncologists to reciprocate and to ask the hard questions? And maybe it's partnering with psychosocial clinicians and palliative care. Maybe it's just a little bit of risk-taking on the part of the oncologists to be curious and say, "Hey, what's on your mind? Many people like you think about these things. I'm happy to talk about them with you too. What do you think?" And then if an AYA says, "Hell no, I don't want to talk about that," fine, we can be like, "Great." But at least we're providing a doorway for them to walk through if they want.

Dr. Fumiko Chino: It reminds me of what Dr. Tarlise Townsend- she gave this profound speech at ASCO Quality from a couple of years ago, and she said she had to kind of do her own death work to kind of come to terms with these issues and really think for herself what she was kind of willing to put up with and for what kind of end point.

Lauren, do you have anything to add?

Dr. Lauren Ghazal: Oh yeah, I just had a follow-up question for Abby too in that you mentioned, you know, you were able to answer, "Will they, will AYAs engage?" and 'yes'. Were you able to kind of decipher if they can engage with other healthcare professionals or other healthcare team members? Is there more of that engagement happening, let's say, with the infusion nurse or with the nurse practitioner?

Dr. Abby Rosenberg: Great question. Just based on the way we measured this, we did not pick that up, and that's one of the limitations of the project is that we didn't expressly ask people, "Who is your person, who are you talking to about this?" Because what we were trying to do is sort of see organically if it came up without prompting. But I think you're right, Lauren, what we know about the experiences of folks with advanced cancers, and this is true certainly in pediatric and AYA oncology, is that it's not necessarily the oncologist who is the trusted person. It could be the infusion nurse. Often, it's the bedside nurse when folks are in the hospital for long periods of time. It could be the chaplain. It could be a whole host of people, the social workers.

And I think what is really important is recognizing two things. One is, we need to honor the interprofessional team and recognize who needs to be in the room for this young person to engage in these really hard conversations And then secondly: how do we still empower the oncologists? And I say that not because I'm elevating the oncologist's role as much as I'm saying the oncologists are the ones who are offering treatment choices and guiding the care plan, and if they aren't part of the conversation, if they aren't hearing an AYA say, "You know what, actually what's most important to me is to be home," then we oncologists are potentially misguiding people. And so how we find that balance, we have to figure out how to integrate all of the players and important people into the room.

Dr. Fumiko Chino: That dovetails so nicely to my next question for Lauren because I know that you had written in The Cancer Letter a couple of years ago that - and this is a direct quote - "Our current status quo is not working. It leaves patients without the resources or the knowledge to be fully engaged. We need more research directed at effective provider-patient communication and tailored interventions that engage the full care team to address each patient's unique needs and experiences." Now, having said that, what would you like to see next in the context of either research or practice to advance this very necessary communication and patient-centered care?

Dr. Lauren Ghazal: Yes, and I had an incredible co-author for that piece as well. It was Fumiko, Abby.

Dr. Fumiko Chino: That's awesome.

Dr. Lauren Ghazal: So she's set me up very well for this. Thank you for referencing that piece again, Fumiko. You know, it's really great that Abby had touched on and everything that she's said so far is kind of what I had jotted down and brainstormed in preparation for this and what I'd like to see next, I think coming from an AYA in really this shift from like just simply documenting communication or communication breakdowns to actively building, testing, implementing solutions and that we know that will center AYAs and their care partners, whomever it is, throughout their experience with cancer. And really taking the time too to note that it's especially important for marginalized and underrepresented groups like queer and LGBTQ AYAs with cancer who we know face additional challenges throughout cancer survivorship.

And so, I'm speaking to the choir here, but we trained as a nurse and as a nurse practitioner, communication in our training, you know, is treated as a soft skill rather than like a clinical competency that really we know has direct implications for outcomes for AYAs that include adherence, that include quality of life, include trust with our healthcare providers and in our healthcare system. And so I always advocate for more interventions that are co-designed with AYAs and their care partners and their communities that really account for structural barriers, identity-based barriers to communication, and that can extend beyond this dyad of just provider and patient but to include our broader healthcare team that include navigators, social workers, nurses, child life specialists even.

And I had another piece that I had written around trauma-informed care for LGBTQ cancer survivors, but we know that embedding even tailored communication strategies into routine care improves care and care delivery, like trauma-informed care practices. And so I also always advocate for proactive conversations around the taboo topics of AYA care that we know things like fertility and family-building, finances, and employment, as you know so well, Fumiko, things about cost-of-care conversations, but all areas where AYAs can see, can often feel unseen or silenced or that it's not important right now because their goal is just to survive throughout this. Yeah, so that's a little bit about kind of my take on communication.

Dr. Abby Rosenberg: Can I just jump in and say, I mean, I think, Lauren, the other thing to amplify from what you just said is if we don't model that it's okay to talk about these subjects, most patients in particular follow the lead of the clinical team. And so if it's not brought up, then the patient will appropriately assume that's not what I'm supposed to talk to my healthcare team about. But if we introduce all these topics and normalize them as part of a holistic care approach, then we're more likely to have these full, rich conversations that need to happen.

Dr. Fumiko Chino: Absolutely, communication is not a soft skill. It is an essential skill for patient care. And again, this idea that the oncologist is the end-all be-all for communication is also, I think, deeply flawed, and thinking about the full team as being a team that actually envelops the patient in care is also essential.

All right. Well, wrapping up, do you have any last thoughts today, anything that we missed, anything that you want to highlight again in terms of opportunities to reinforce for our listeners from Lauren or Abby?

Dr. Abby Rosenberg: When I think about this whole horizon of research and clinical care, to me, I guess I'm taking away two things. One is to really be unafraid, those of us who are at the bedside, in whatever role, to open the door to these pathways of communication about all sorts of scary topics because then we can provide better care. And then the second, I think now, as a resilience researcher, is we can expect and normalize that some of these coping skills can be learned, and the investing in them in an evidence-based way can have these durable impacts in overall patient and family well-being, and so it's worth the investment.

Dr. Fumiko Chino: We're worth it. Our patients are worth it. I was just thinking about as a caregiver, how much I wish resilience training and coping skills had been directed at me, selfishly again, I'm sorry, I'm again, this is all about me, apparently. But I do think that that might be one of the next frontiers as well because the caregivers really are part of that team unit that helps envelop the patient in love and care and support.

Dr. Abby Rosenberg: Well said.

Dr. Lauren Ghazal: I'm snapping for you, Fumiko.

Dr. Fumiko Chino: Well, on the exit of the snaps, then, I want to thank you both so much for this wonderful conversation. Many thanks to both Dr. Rosenberg and Dr. Ghazal as well as our listeners for your time. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.

I hope that you will join us next month for another Put into Practice episode, and until then, I hope you are staying safe.

Dr. Abby Rosenberg: Thanks, everybody.

Dr. Lauren Ghazal: Thank you.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Abby R. Rosenberg

No Relationships to Disclose

Lauren Victoria Ghazal

No Relationships to Disclose

TRANSCRIPT

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

There is often a disconnect in toxicity assessment between what is reported on clinical trials as being, quote-unquote, "well tolerated" and the lived experience of taking a treatment for patients. Toxicity-minimizing language includes words like "safe" and "tolerable." They are subjective and can downplay quality of life–limiting side effects from treatment. A recent paper published in JCO OP reported that less than half of phase 3 clinical trials had complete toxicity reporting, including total adverse events, deaths, and discontinuations due to side effects.

I'm overjoyed to welcome two guests to the podcast today to discuss patient-centered clinical trial design with a focus on side effects from treatment.

Dr. Ethan Ludmir is an Assistant Professor at MD Anderson Cancer Center with a primary appointment in GI radiation oncology. He is a prolific researcher on topics encompassing clinical trials, cancer outcomes, and the integration of biostatistics in oncology. He has a specific interest in improving clinical trial design, including designing patient-centered endpoints and complete reporting. He led collaborators in the manuscript that will frame our discussion today called, "Incomplete Toxicity Reporting and the Use of Toxicity-Minimizing Language in Phase III Oncology Trials," which was published earlier this year in JCO OP.

Stacey Tinianov is the executive director and co-founder of Advocates for Collaborative Education, a global advocacy organization uniting patient, research, and policy advocates through pan-cancer collaborations, basic and advanced advocacy education, and the sharing of leading practices to change the narrative in cancer outcomes. Following her diagnosis and treatment for early-stage breast cancer 12 years ago, Stacey  has become a leading national voice for patient advocacy and empowerment via collaborative education, community building, shared decision-making, health data access, and person-centered design.

Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the episode today.

Ethan and Stacey , it's wonderful to speak to you.

Dr. Ethan Ludmir: Terrific. Thank you so much for having us, Fumiko. It's a pleasure to be here with friends and colleagues of many years to be able to talk about this important topic.

Stacey Tinianov: Yes, thank you. Delighted to be invited, delighted to be part of the conversation.

Dr. Fumiko Chino: Our specific topic today is toxicity minimization, either by underreporting or by language and framing that downplays the lived experience of treatment. Ethan, do you mind starting us off by telling us how you got interested in toxicity reporting and then briefly discussing what your study team did and the findings?

Dr. Ethan Ludmir: Absolutely. Thank you, Fumiko. I have the privilege and luxury of being able to present research that is 100% the brainchild and terrific work of colleagues and friends, including the first author, a terrific graduate student named Avi Miller; colleagues like Alex Sherry. So I think it's always important to acknowledge I'm here mostly for window dressing. They really did the lion's share of the work and really have reported this fascinating story.

Our lab works primarily on issues related to the optimization of clinical trial design and reporting. One of these key topics that has come up more and more over the course of time is how are we presenting toxicities? And so we gave this project the sort of cute name of "The Table 3 Fallacy." Right? When you present a clinical trial report, usually Table 3, just by the way things end up getting numbered, is generally where you find these toxicities. You see a massive Excel sheet of reported toxicities, and invariably it ends up kind of culminating in a sort of pithy couple of sentences saying, "Toxicity was manageable."

So we wanted to really drill down on this with sort of two features in mind. One of them was, how well are we doing at objectively reporting physician-assessed toxicity? And of course, that comes with the itinerant kind of limitation that all three of us have both written about and talked about, that is physician-assessed toxicities are very different than patient-experienced toxicities - and maybe we'll put that to a side for one second - but objective toxicities on one hand and then subjective characterization of those toxicities on the other.

So for this project, we looked at, we've sort of cultivated over the years an actively updated database of every phase 3 trial that's been completed in clinicaltrials.gov since the website's inception. And so in this report, we looked at over 400 trials representing over 300,000 patients enrolled. And we wanted to assess objectively how many trials reported in their manuscripts serious adverse events, treatment-related deaths, study therapy discontinuation, and an emerging area that really bears some emphasis, which is reporting of lower-grade toxicities. And I know we're going to discuss this as this moves forward, but especially in the last few years, this has entered visibility as an area that we really ought to be emphasizing more. As a sort of anecdotal point, it's very easy to characterize a single grade 3 episode of toxicity that potentially is self-limited. But on the other hand, if you've got a patient who has the misfortune of having grade 2 nausea day in and day out - sure, that's grade 2, but that can be much more impactful on somebody's quality of life. So being cognizant of these kinds of differences is important.

So we went through these 400 trials and objectively categorized using pre-established guidelines how many reported serious adverse events, treatment-related deaths, study therapy discontinuation. And the answer is only 44% of trials consistently do this. We added and created sort of our own guideline - everyone comes up with guidelines these days, so we said we're going to do our own guideline - and add into the mix reporting of lower-grade toxicities. And if you call "complete toxicity reporting" doing what's been done before and reporting lower-grade toxicities, then only 32% of trials report out these complete toxicities.

And perhaps the most interesting covariate there is that our industry-supported trials, which increasingly dominate the scene, those tend to do a better job at reporting toxicity profiles than cooperative group–sponsored studies. And we can kind of dissect that, perhaps, on the back end.

And the final point is we looked at how often investigators are using language like, "Study therapy had toxicity that was acceptable or tolerable." These subjective languages that fundamentally minimize the experienced toxicities. And the answer is nearly half of trials report- have that language in the study text itself, often in the discussion section or the abstract. And this is what's picked up, right? This is what our patients read. This is what news outlets read. And I think this really fundamentally undermines a lot of the nuances here. But if you let me keep talking, I'll just keep talking forever, so I'll stop talking.

Dr. Fumiko Chino: That was a really excellent summary of what your team did, and I agree 100%. Give credit where credit is due. It is a whole team that brings research like this to publication, and so I really always respected the fact that you have worked in very large teams and have given due credit to people like trainees along the way that are doing some really elegant work under the auspices of the- I'll just call it 'The Ludmir Lab'.

Now, as you mentioned, patients may really consider side effect profiles very differently than what investigators determine could be, quote-unquote, "clinically relevant." Stacey, I'd really love your take on the toxicity topic and how you've seen this play out in both the advocacy space and in your role as a scientific advisor.

Stacey Tinianov: First of all, I am truly thrilled that all of this is being examined. We know that words matter. We know that we've managed to change our collective language in the oncology space and our understanding significantly of that impact in the last 10 years. We've modified phrases like, you know, "patients failing treatment" and we've moved to what is kind of more "what actually failed patients". So, you know, I think the key piece there is when we describe things like "manageable" and "tolerable" in scientific publications or in that Table 3, we are looking at "clinically relevant". And so I want to acknowledge that when you talk to people in clinic, you know, "manageable" means that there's a way to clinically manage a side effect. "Tolerable" means that treatment can continue. So we understand where these phrases originated from. However, as Ethan mentioned, these terms have very different meanings in day-to-day living.

I spent some time actually quite recently at the FDA talking about the gratitude I have that, you know, safety and efficacy is a primary concern for the FDA because as advocates and certainly as patients, we care about safety and efficacy. But we also are incredibly concerned with quality of life, and it's particularly important to say because all of these great therapies are only great therapies if individuals can stay on them. And if these so-called "manageable" and "tolerable" side effects, as they start to accumulate, people have to come off treatments, well then all of that incredibly hard work and all of those resources to bring something to market are for naught.

The other thing I think it's highly dependent on individuals, and I think that, again, when we quantify and when we, you know, qualify something, we have to do it kind of in a population setting. And yet I think we need to acknowledge that all individuals are different, and something that may truly be "manageable" and/or "tolerable" in one individual might not be in another. And so I think we need to make room for that. And the reason the language is so important is so we can make those choices. We can weigh the benefits to the risks, not just on a cellular level, but on an impact level. So again, so excited to have this conversation.

Dr. Fumiko Chino: I love that personal take on it, which is that it is personal. You have your own experiences, obviously, with toxicities, but that individuals may not be comparable across each other and aggregate number on a spreadsheet is very different than lived experience.

Stacey Tinianov: When you look at those hundreds of thousands of individuals, those were the cancer Olympians. Those were the individuals that qualified for a clinical trial because even though they were sick and in some cases very, very, very sick, they were the best of the best. And so that toxicity profile is on a population that has actually made it into a clinical trial. But once a drug is approved and once it's put into market, it's potentially available to anybody, and so we see those side effects, you know, sometimes in a much more complicated situation. But too, you know, again based on the individual, even if this drug gets out and it's the same diarrheagenic profile for one individual as another, the impact of that on a quality of life is very, very different. Somebody who really enjoys sitting outside and birdwatching and hanging out with friends and reading books, as long as they're within ten feet of a bathroom, the diarrheagenic effects of a drug are going to impact that person probably far less than somebody who rates their quality of life on how many summits they can peak.

Dr. Fumiko Chino: 100%. I can even say for my own lived experience, when my father-in-law received cancer treatment, they actually chose one of his treatments based on the fact that he is a guitar player, and so they really wanted to minimize his risk of peripheral neuropathy. And so, you know, instead of cisplatin, they chose cetuximab for his treatment, even though it is maybe suboptimal in a straight numbers comparison, but the toxicity was very meaningful.

Now, there was another recent JCO OP study published this year focusing on patients with melanoma on immunotherapy. It found that of the 70% of patients with any toxicities, about half of them were, quote-unquote, "only" grade 1 or 2. But in this so-called "low-grade toxicity," 15% were hospitalized, 31% had treatment stopped because of toxicity, 33% needed to go on an immunosuppressive medication. Now, Ethan, do you mind putting this into perspective from the kind of clinician and clinical trialist standpoint?

Dr. Ethan Ludmir: With pleasure. And this is a terrific piece and really highlights and informs a lot of the reasons that complete toxicity reporting is crucial. Right? We need to know about the grade 1-2 side effects because invariably, as much as we like to relegate those to second-class status in how we've to date been characterizing physician-reported toxicities, clearly, there's a dramatic impact in many of those toxicities on people's ability to tolerate therapy, their ability to require additional intervention like immunosuppressives, and it's really quite central in the way we think about things.

The other facet, I think, that's increasingly relevant here is the treatment discontinuation aspect of things is one that increasingly from a statistical perspective comes to the fore. We've written about this before in a couple of different pieces, but it's something that I'm not always sure gets enough billing, which is that study therapy discontinuation is often not considered an event. And so when you design Kaplan-Meier curves and you report these out, those patients are censored rather than marked as having an event. And so you get weird statistical effects of how those curves are perceived because you're almost ignoring the folks who had the toughest time with the therapy when those are among the most informative patients when you're thinking about things from both a large-scale regulatory perspective to Stacey 's point, and again to Stacey's point, the individual in front of you.

So I mean, it's a terrific piece of work and also speaks to, as we think about the era of PROs really getting more and more mature in how we analyze them and integrate them into our trials, it also speaks to the challenges of just objectively quantifying toxicity from a physician perspective as tick mark "That is one grade 3 toxicity." Can we make this multidimensional? Are we thinking more about the time perspective? How long is the grade 2 toxicity going for? Are you having a day of nausea or continuous nausea for a month? These are the things that I think are relevant as we think about optimization of our endpoints going forward.

Dr. Fumiko Chino: Patient-reported outcomes has entered the chat. I love it.

Now, Stacey, do you have anything to add from a patient perspective?

Stacey Tinianov: I absolutely do, and I think the discontinuation piece is critical. But again, I also want to add that once things get approved and are in market, it's not a digital discontinuation or continuation. We have, obviously, dose reductions that tend to be led by clinical expertise. But what we're seeing in the community, especially with some of these newer targeted therapies, is individuals medicate themselves. For instance, diarrhea, you know, fatigue, there's a lot of very, very clinical side effects, but I think diarrhea is the one I like to focus on because I don't think I've ever talked to anybody who has not experienced diarrhea. So I think there's a level of understanding and empathy there. But when we look at some of these diarrheagenic, especially in the CDK4/6 space, we have individuals who, one, because it's manageable and tolerable, are given an over-the-counter prescription for an antimotility drug, and that drug then causes another side effect, and this side effect isn't measured. This is not in the toxicity profile of a therapeutic. It's in the toxicity profile of the supportive care medication. And so what we're seeing is this incredible cascading effect of diarrhea, constipation, diarrhea, constipation, diarrhea. And so patients say, "You know what, enough is enough. I'm about to go on a vacation. I'm going to take two weeks, and I'm not going to take my meds." And whether they communicate to their doctor or not probably depends a lot on their relationship. But from a drug standpoint, with these drugs, we don't know what that does, right? And so we know that we have people not taking the therapy as it was intended and approved, and this is directly a result of the side effects.

The other piece is, I think it's important to note that when we think about side effects, I think oftentimes we think about a finite period of time, but some individuals are on drugs forever. They're on it forever until it stops working. And so, if you say that, okay, fatigue is really, really a challenge, but if it's your new regular, you're never going to feel better than this, that's a really hard decision to make.

The other piece is, again, I think that when we think about these grade 1 and these grade 2 side effects, we don't necessarily visualize what that actually means. And so going back to poop, because we all like talking about poop, you know, a grade 2 side effect - and one of the things you already know - is defined as four to six loose, watery stools as baseline. So one of my favorite conversations or favorite phrases or questions, I guess, is to say, "You know, just take a second. Where in your busy day would you put four to six extra loose, watery stools?" And then, you know, you're like, "Oh my gosh, that's not tolerable." So it really is just this like huge, huge, huge consideration for people, and I'm not saying that these drugs shouldn't be on the market, but what I am saying is when you publish the results of how these drugs affect individuals, that needs to be part of the conversation so it can be part of the shared decision-making.

Dr. Fumiko Chino: 100%, 100%.

Now, Stacey  and I both just returned from ASCO 2025, where the so-called "latest and greatest" new treatments were showcased. There were at least a handful of times where I heard that X new treatment was both efficacious and tolerable without any patient perspective presented. And it's been over four years since I heard the incredible Jill Feldman speak about the importance of patient-reported outcomes, including her famous slide highlighting the difference between how you look and how you feel. Stacey, you've been in the advocacy space for over a decade. Do you think we're making any progress over time on this issue?

Stacey Tinianov: I should probably lead with the fact that I am an optimist. So my answer, my answer is 'yes'. And I mentioned earlier that I've watched the focus on words and and our language is starting to change based on the recognition that words matter. I think for the most part we don't call individuals who decide to join clinical trials, we don't call them 'subjects' anymore. We're recognizing them as humans. We're also incredibly excited about what is starting to be presented on the main stage. I know that, you know, at this past ASCO, we had, you know, many individuals who were on stage as advocates in conjunction with the luminaries in the clinical and the research space. And so I think that's progress because I don't think there's one advocate who wasn't on stage to kind of share, you know, some of these similar concerns.

But we're also seeing it in the research space itself. So Advocates for Collaborative Education decided that quality of life was something that was not being well studied and not being well represented. So a couple of years ago, we actually did an advocacy-led study, "More Than a Diagnosis: A Quality of Life Survey for Individuals with a History or Diagnosis of Cancer." We did it because we knew it needed to exist. We also created our own survey because the current validated measurement tools that look at quality of life, one, they're administered by a clinician, right, so you're not necessarily getting that- they're not necessarily looking at the things that we as patients care about. So we created this survey with patients and with advocates. And the most exciting thing is once we accrued - we had 516 responses across a variety of cancers, and we did this in a matter of five weeks - and we submitted abstracts to SABCS, to ASCO, to ASCO Quality, and we've had posters or presentations at every one. We are talking about these words "manageable" and "tolerable," but more importantly, I think we're talking about being able to integrate quality of life into the decision-making process in clinic and also integrate quality of life into how we evaluate from a patient-reported outcomes standpoint in the clinical trials. And so it's a process. I recognize it's a process, and I also recognize for those who are struggling now, it is moving too slowly. But ultimately, and I know the three of us can agree, when choosing cancer therapies, people should not have to choose between being alive and living. So living, really, really living is what we're focused on.

Dr. Fumiko Chino: Absolutely. I would say quality of life and quantity of life are both equally important. Ethan, do you have anything to add to what Stacey  just eloquently said?

Dr. Ethan Ludmir: Candidly, she framed it exactly the way I would want to if I were more eloquent myself. So no, I think that's exactly where we're at. I live in my own little pond of statistics, so a lot of things that I'm worried about deal with how we're measuring quality of life, how we're analyzing it. The devil is usually in the details there, but on one hand, like, that's something I feel is a direction that, kind of behind the curtain, the statistic- statisticians really have to do a lot of work and education to get there. But in a certain way, that's a much easier challenge than what both of you are describing now as we see sea change at the level of who's talking at ASCO, who's being brought into the conversation and trial design, whose voices are being heard and propagated. So I think the math is much easier to work out than the vision. And so kudos to both of you for spearheading that vision and seeing it realized, I think, in real time, which must be very, very rewarding.

Dr. Fumiko Chino: I've been so enthused about how many patient advocates I've seen on both big ASCO and then, of course, ASCO Quality, the health services meeting. I know that at least the session that I had at ASCO had a patient advocate as a speaker. So I think, again, our sort of ideal world is that every single session has a patient advocate to help frame the research and the data from the perspective of the lived experience of someone on cancer treatment or a survivor of cancer.

Stacey Tinianov: It's so important for me to acknowledge that none of that would have happened without people like you that are embracing it. We recognize, advocacy recognizes that we needed champions on the inside to be able to come in and share those perspectives. We so, so recognize that. So, thank you for that.

Dr. Fumiko Chino: We have a mole in ASCO, and it's a patient-centered mole. Thank you for that.

All right, switching tack just a little bit for our last little bit of the podcast. Ethan, I know you've been on really a mission to improve clinical trial design and really have a growing body of meta-research or, you know, "research about research." Why is meta-research important, and how do we learn from it to refresh and reinvigorate clinical trials so that they provide better information to providers but also more meaningful outcomes to patients?

Dr. Ethan Ludmir: That's a terrific question. A little bit loaded in the life and times in which we live right now, but a terrific question. So I think clinical trials are fascinating. I think there's tremendous avenues of opportunity in how we design them, how we execute them, how we interpret them, how we analyze them. So that gets me up in the morning. That really puts a skip in my step. I love JCO OP. I will put in the very smallest of plugs for a different journal in which we just published a report two days ago that was presented concurrent at ASCO on how many clinical trials in the last 25 years have actually moved the needle in quantity of life or quality of life. And I know all three of us can share this perspective, you know, each with different words, but at the end of the day, that's what matters. We need to know that whatever we're doing, we're improving somebody's quality of life, their quantity of life, or ideally both. And so my trainees kind of hear me say this repeated often and often and often. And I think it's very important because in many ways, for a little while now, we've lost the thread at the regulatory level, at the sponsor level, and that's nothing new. There's a lot of ink that has been spilled about this. But the beauty of meta-research in a certain way, and to be clear, I'm a clinical trialist in my day job too, and I think there's a key role of not just being there and being an armchair quarterback, but then living it yourself and running your own trials and having to work with sponsors and partners, ensuring that you involve patient advocates and hearing their voices, not just ticking a box off on a checklist.

Meta-research gives us this separate avenue to really sort of think about things, trying to see the forest through the trees. What really does evidence-based medicine show us? Where are we doing well? Where are we not doing well? There's a tremendous body of literature that, in our small way, we've contributed to some of those conversations, and we're incredibly proud as a group about that.

But especially in an era and a time when the structure of evidence-based medicine is being called into question, the validity of evidence is being called into question, I think in many ways, it is easy to be on an extreme. It is easy to take a flag and plant it on a hill and say, "I believe X or I believe Y," and the other side, another view, is completely wrong. And as I tell my trainees, many of these people are also in that meta-research space, and I try to spend a lot of effort to say, we might not get the flashiest headlines, and a lot of journals, and I'm very grateful that JCO OP is not among this number, will specifically want papers that are almost trying to be inflammatory. And we very much want to paint an even-handed picture. Here's what we're doing well, here's what we suck at, here's how we can move forward. Do you make changes through editorial policies or regulatory policies? Do you make changes just by, as both of you have done, keeping that conversation alive, using the media and the forums you have at your disposal to just say, "This is something we need to be talking about more and focusing on"?

And I think the the important thing that I carry forward, especially as we see changes at the regulatory and the administrative levels, are that use the data in front of you, analyze them with integrity, present them with integrity, and say, "Here's what we're doing well, here's what we're not doing well, here's the believability of our data, here's where we think we're weak." And invariably, the truth is somewhere in the middle. President Eisenhower said, "The middle is a very lonely place to be," but invariably, it's right. And I'm definitely butchering that quote, so you'll forgive me, but that's very much kind of how I think we should be approaching things, is that even-handed, "What are we doing well? What do we need to work on? And how do we find the right partners to get us there?"

Dr. Fumiko Chino: Absolutely. I know that Dr. Sherry, who presented that research you mentioned that was simultaneously published in JAMA Oncology, relayed the research showing that very few trials are powered to an overall survival benefit and so they're not showing that. Very few trials are showing a quality of life benefit, and even fewer than few trials are showing both an overall survival and a quality of life endpoint. What was striking to me is that one of the people who came up to the microphone said something along the lines of, "Well, if you have this, you don't need to measure quality of life," and I was like, "Hold me back," because quality of life no matter what is one of the most important endpoints. If you live two months longer but it's in pain, I'm not sure what the living is. I say this as a cancer widow.

Now, Stacey , anything to add given your role as a patient advisory for new treatment testing, for development, for patient education? Anything to add? I know you have an opinion about this.

Stacey Tinianov: Well, I have opinions about a lot of things. But I want to, you know, thank you for bringing up the divisiveness that exists, and I think that the divisiveness that exists in society is obviously impeding our work. But in advocacy, we're there for every individual, and we're there to advocate for the best possible outcomes and the best possible experience for every individual. And cancer's incredibly nondiscriminatory. It really doesn't matter if you're a, "I did my own research," or if you're kind of leaning into evidence-based medicine. And so I don't know that I live in the middle, but I definitely think that there's a lot of value in being the bridge. Just sitting in the middle and observing, I think, maybe it's just not enough action for me, but really trying to figure out what are the things that we can agree on. I think we can agree on quality of life. I think we can agree on 'we need to do better.'

I will say I'm excited because I do feel like things are changing. And again, change is hard and sometimes change is slow. But we do have groups, you know, the Patient-Centered Dosing Initiative, a group that was started by a few metastatic breast cancer patients that said, "You know what? We are overdosing people," and we kind of know that because the way we approve drugs is to get to the maximum tolerated dose, a little over, and then pull back. That's where we then go through the rest of everything else. So of course these toxicities are high. I, and I can't quote the source, but this week, I learned that approximately 1% of payload in some of these large ADCs actually gets through. And a lot of that depends on, you know, how much is going to be able to filter through, but what that means is we are giving such a high load that of course these toxicities are high. And so I think the more we know, the more we can address. There will be situations where it is what it is and people will just need to decide what's right for them.

But I think from a clinical trial standpoint, I think, you know, again I'm preaching to the proverbial choir here, advocacy and helping making trial designs, trial protocols much more friendly to the individual who's going to sign up, it's a win-win for everybody because we're going to be able to accrue. We're going to actually be able to do the research and we're going to be able to get people who understand why they're participating, what the potential benefits and risks are, and that's going to really help with reducing the attrition rate. It's really going to help with people who are committed to making sure that we can see this through. So I love this. I think, you know, a goal for me is to see more lay summaries on our research. I think let's communicate what we're doing and the impact of what we're doing so that the rest of - on both sides of this bridge - so that the rest of society has a better understanding.

Dr. Fumiko Chino: One thing that you said really stuck at me as a treating physician is that I've had patients on, let's just say a CDK4/6 inhibitor, who really were underplaying their toxicity to their medical oncologist because they did not want to get a dose reduction. And I have to be, "You know what, on that clinical trial," I have it here, "70% of the people on the clinical trial, the Olympians of clinical trial participation, they needed a dose reduction, and we still get this benefit from 70% of those people had a dose reduction." So it is okay for you to have a dose reduction as well. And I, you know, I have to emphasize that to patients fairly frequently how important it is to balance the what you're getting out of it and what it's putting you through.

Stacey Tinianov: With regard to that, and I think that's a fantastic topic, the way that dose reduction is often communicated and especially communicated in meetings like ASCO and all the other meetings, is it's de-escalation. And de-escalation, it's a technical term, and it also, especially to individuals who are new to the oncology space and new to treatment, it feels like they're getting less than. You're de-escalating, you're getting less than. And so I think when it's framed as "right-sizing," "Yes, this drug was approved in a population, and right now what we're doing is we're right-sizing it for you as an individual," I think the comfort level in individuals is much, much higher for that. So, and I know you do because I know you.

Dr. Fumiko Chino: That's funny. As a radiation oncologist, we're constantly de-escalating. I put that in quotes, but I have shifted it to "right-sizing" more recently because I think I might have heard you say that, and I thought, "Well, that is actually great language, and it's very patient-centered language."

As we wrap up our time on this podcast, I want to just give a little bit of space at the end. Is there anything that we missed, any large topic that is uncovered, or any last thoughts before we close out? Ethan, anything from you?

Dr. Ethan Ludmir: I echo Stacey entirely. I think there's a tremendous opportunity space, even in today's slightly politically charged environment, to be robust and earnest in our research, to maintain continuously the focus on patients, right-sizing rather than de-escalating, talking about toxicities in a meaningful and appropriate way, understanding the validity of not only the results for the individual but now taking again a big step back, the results at the population level, the results for clinical trial populations, and the general population.

As much as we live through chaotic times and and these are tough times, I think this is in certain ways an important opportunity for us to continue focusing on what matters. And I remain just as Stacey, ever the optimist, that we're going to maintain the positive direction, address the things that we need to address. And sometimes I always feel a little guilty writing papers like this because the purpose is not to say that we're doing something wrong or bad, but rather, here are areas of easy, layup opportunities for improvement. And I think those remain sort of the important things to keep in mind, even in a divisive environment. There are easy ways to bring everyone again back together and improve where we're at.

Stacey Tinianov: So well said, Ethan, and I just want to acknowledge that everything that happens in this conversation and kind of the larger academic medical world, we need to be having these conversations in community because we were just with 44,000 of our closest friends in Chicago, but how many other thousands and thousands of oncology professionals, advocates, and patients were not in the room and actually won't actually receive any of this information for potentially years. So as we start to think about how we can right-size and reorient in the clinical trials space and in the reporting space, we also need to be thinking how we can start to right-size and reorient in clinical care, not only in these large academic medical centers that are so plugged in, but in these smaller rural community settings where, I promise you, they're having the same adverse event experiences, just maybe not as wonderfully supported.

Dr. Fumiko Chino: It's a great way of ending the podcast. Thank you so much for this wonderful conversation today. Many thanks to both Dr. Ethan Ludmir and Dr. Tinianow, as well as our listeners for your time today.

You will find the links to the papers that we have discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope that you will join us next month for Put into Practice's next episode. Until then, I encourage you to think deeply before saying that a treatment was "well tolerated."

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Employment

Company: MD Anderson Cancer Center

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Stacey Tinianov

Consulting or Advisory Role

Company: Blue Note Therapeutics

Company: ARTIDIS

Company: Napo Pharmaceuticals

Travel, Accommodations, Expenses

Company: ARTIDIS

Company: Napo

Ethan Ludmir

Employment

Company: Alaunos Therapeutics

Recipient: An Immediate Family Member

Honoraria

Company: Nanobiotix

Consulting or Advisory Role

Company: Xerient

Transcript

Dr. Fumiko Chino: Hello, and welcome to Put Into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Frustrations regarding the costs and difficulties with parking at hospitals are some of the most common concerns voiced by patients, families, and healthcare providers online. There is nary a topic where you'll find a more unified level of outrage. Transportation barriers to receiving cancer care are incredibly common, despite what appears to be a relatively straightforward solution—to parking costs, at least.

To discuss this, I'm excited to welcome two patient-centered health policy experts as guests today. Both have published work in JCO OP about transportation barriers.

Dr. Arjun Gupta, MBBS, is an assistant professor at the University of Minnesota. He is a gastrointestinal oncologist, a symptom management enthusiast, and a health services researcher. His research examines cancer care access and delivery, the cost of cancer care, and the hidden burdens imposed on and faced by people with cancer and their caregivers while receiving this care. His 2020 editorial, "Park the Parking," documented parking costs at the top US hospitals as a source of financial toxicity.

Dr. Shakira Grant, MBBS, MSCR, is the founder and CEO of CROSS Global Research and Strategy, a boutique consultancy focused on advancing equity-centered strategic solutions to complex healthcare challenges at the local, national, and global levels. She is the former health policy advisor to the US House of Representatives Ways and Means Health Subcommittee. Prior to that, she was an assistant professor at the University of North Carolina. Her qualitative analysis was published earlier this year and is called "Paying to Be a Patient in the Hospital and the Parking Lot: Patient-Caregiver Dyad Perspectives on Health-Related Transportation Access in Multiple Myeloma."

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Arjun and Shakira, it's exciting to speak with you today.

Dr. Arjun Gupta: Thank you. It's a joy to be here, Fumiko.

Dr. Shakira Grant: Thank you so much for having me also.

Dr. Fumiko Chino: Our specific topic today is transportation barriers to receiving optimal cancer care. This concern fits within the larger focus of addressing the social determinants of health, with the goal of improving access to high-quality cancer care for all. Research on health-related social risks and needs has proliferated in the last decade, and recent evaluations of food, housing, and transportation insecurity have expanded our knowledge on the barriers that some people face to receive care.

Arjun, do you mind starting us off with just a bit of background about why these issues matter for patients?

Dr. Arjun Gupta: Sure. So, just some background on social determinants of health. These are non-medical factors that are often at the community level that can have direct impacts on both health and health outcomes. So, these are all the issues that are associated with living and our daily lives: where we live, where we work, do we play, and what we play. All of these issues can, of course, impact what sort of medical conditions one might develop, but also the medical care that one might be able to receive.

And we think about someone who does have access to public transportation or does have access to a private vehicle, for example, or someone who is a daily wage earner or an hourly wage earner, or someone who lives next to a toxic wasteland and is exposed to chemicals. So, all of these factors can, of course, influence our health risks. And as one can imagine, all of these social determinants of health can lead to health risks or social risks.

And so, my real interest in this topic came about when I was a first-year oncology fellow. So much of our training in residency is on the inpatient side. But when we had our own continuity clinic in oncology during my first year of fellowship is when I realized the importance of parking and transportation for the first time. When a patient who was receiving FOLFOX chemotherapy for colon cancer, I asked them if they wanted to get blood work a couple of days before chemotherapy so that they wouldn't have to wait for the blood work to result on the day of chemotherapy, and they very passionately said, "Oh, of course not. I only want to come in one day because the parking costs $12, and Christmas is coming up, and I need to buy presents for my grandkids." And that really, really struck me.

I remember reaching out to you, Fumiko, at that time. We were junior investigators and launching our careers in oncology on what is going on and why is this real. And I think we'd done some work parallelly to highlight how these major cancer centers were charging obscene amounts for parking, which for an individual visit may seem very small, but of course, cumulatively can be large amounts. And also the fact of the nickel-and-diming that comes in for these very, very vulnerable patients and care partners.

And my interests in these transportation and parking costs and barriers have evolved since our research group has been working on time toxicity. So, over the last couple of years, this concept of the time burdens of cancer care has evolved. And initially, we were largely focusing on the amount of time spent in medical appointments. So, you go up, and it takes so long. And in qualitative interviews, patients brought up that even for simple blood draws, "I'm actually spending three, four hours out of the home." So, we actually looked at this formally because our oncology discipline didn't believe this data. They kept thinking a blood draw is 10 minutes tops; you just ask a patient to come in.

At our cancer center, patients get a radio frequency ID badge when they enter the clinic. This is to track them within the cancer center. So, using that radio frequency ID badge data and the average driving time through their home zip code, we found that actually, even a simple blood draw was taking people more than 3 hours, home to home. And I actually made a couple of residents walk from the parking garage to the entrance of the cancer center and found that it was a median of 7 minutes one way. Now, remember, these are mostly young adults in their 20s, not walking in the Minnesota snow. So, you can imagine someone who's an older adult, at risk of slipping, walking much slower. So, all of this to say, these are major, major issues that patients and care partners face, and I was very excited to read Shakira's work on this topic.

Dr. Fumiko Chino: I love how you walked us through the granular of the patient interaction that then drove you to research this type of study because, initially, you were trying to be very patient-centered in your approach, which is, "Let me separate the lab from the visit so we can save you some time." But what they told you was that, "Hey, it actually costs me more money, and it may not actually save me any time." And I think that dovetails really nicely into thinking about the study at hand, the most recent study. And Shakira, your study on transportation barriers really just came out, and it highlights the voice of the patients and the caregivers on the lived experience of cancer treatment. And one patient from your study specifically said that their travel to receive cancer care was not only wear and tear on the cars but wear and tear on the body as well. So that echoes what Arjun just said. And I think that quote really nicely highlights that it's the costs, it's the time, it's the stamina required to navigate the hospital. These all contribute to the burdens that our patients and their families carry.

Do you mind, Shakira, giving me a brief overview about why you did this work and what you found?

Dr. Shakira Grant: Sure. So, I would say to dovetail on a lot of what Arjun said, this came also what I was seeing firsthand in the clinical practice. And at the time when I was directly involved in patient care, my population was caring for older adults, primarily with multiple myeloma. My background is as a geriatric oncologist, and so by and large, that meant that most of my patients are over the age of 65. But apart from age, they're also battling other things such as disability and other chronic conditions that impact their functional ability.

And so, I kept hearing stories over and over, not only from patients, but I recognized there was an integral part that is often overlooked in clinical care, and that is the voice and the role that caregivers play, especially when we're dealing with older adults who may not have the independence to drive a car themselves to get to the cancer center because it might be disability, it might be other chronic conditions that impair their ability to operate a vehicle. And they kept talking about the same issues around accessibility of the parking structures, the time it takes for them to drive from their homes, especially when they're having their chemotherapies or other cancer therapies, and that may impact them by not feeling physically well and then needing to still get to the cancer center to see a physician or to receive additional treatment.

And then on top of that, similarly, I heard the concerns about parking because parking was not free at the cancer center for patients. And so, this is an hourly rate, and the longer you're there, you pay more money. And for many of these older adults, they're already on a fixed income, and so it becomes very difficult for them. Even though for someone who's working and has a nice buffer of income, they may be able to readily afford $12 or $15 to pay to park every time you come to the cancer center. But if you're on a fixed income, that becomes more difficult. And so that was one of the real driving reasons behind why I wanted to do this type of research in this particular area.

Dr. Fumiko Chino: This work from your team is really an excellent example of patient-centered research and explicitly examining and prioritizing the voice of the patient and the caregiver, their experiences as an avenue to help clinicians and researchers and policymakers understand where care gaps exist and how we can be doing better. And I'd love to hear from each of you why you specifically feel like this type of research is important - I know you've already mentioned some of it - and the range of patient-centered research that you have done in the past or you hope to do in the future. What is the unique knowledge that this research allows us to gain beyond some of the standard research paradigms?

Dr. Shakira Grant: I think patient-centered research is really critical, not just in helping us to set the stage as clinicians, as researchers, but it becomes important for policymakers because oftentimes, we hear the stories, and the stories are the things that are most powerful. They speak to the emotional need of people, and that in itself can be very powerful, especially when you're trying to interact with policymakers about why this particular issue is important. It is easier to do that when you have a story, when you can put a face to what is actually happening. So, it doesn't seem as abstract if we're just talking about quantitative data where we're analyzing and putting out a lot of statistics. We're talking about this patient, their caregiver, their lived experience. These are the real barriers.

So, I really appreciate doing patient-centered research because it centers the voices, the lived experiences, and that just enriches the experience, and it also gives that emotional and psychological appeal that is sometimes necessary to get the attention of policymakers and other legislators.

Dr. Arjun Gupta: Absolutely. And to follow up on that, I think Shakira's point about telling stories is very important, especially these days. We've seen so much misinformation. And I think for me personally, as a researcher, learning how to do mixed-methods work, especially qualitative work, to be able to integrate stories into all of these quantitative data elements that we have is extremely important.

To that point, I will say that when starting to research parking costs, the most impactful blog that I read on this topic was about parents whose newborns were in the neonatal ICU or the NICU. And it was such a beautifully written blog, asking someone to imagine their biological child in the neonatal ICU. And if the child had two parents, then each of the parents trying to balance work and coming to the NICU and having to pay parking fees twice a day. And to have to do that day after day and week after week and month after month, I think it's very important to share that part of the story and the horror along with that element of, "Okay, it cost $10 each time."

And so, when I think about patient-centered research and how I best integrate my skills and interest, I think about symptom intervention trials. So, how do we make people feel physically better through things like medical cannabis and access through that? And the other big thing is exploring and intervening on the financial toxicity of care, the time toxicity of care, and the logistic toxicity of care.

So, Fumiko, you've been such a champion for financial toxicity over the years. And just to go back in history a little bit, before Dr. Zafar coined the term "financial toxicity" 10-15 years ago, being bankrupt from cancer care was just something that happened. It sucks, it happens. But since then, it's been named, it's been shamed, and it's been intervened upon. And that's my hope with the time toxicity field now over the last two, three years.

And the latest thing that our group has sort of worked on while studying time toxicity is that it's not just the time outside the home, but it's also all the paperwork and administrative burden that goes along with it. And so, our team is currently trying to provide patients with proactive legal support to actually help with medical debt, insurance denials, things like that.

Dr. Fumiko Chino: I like that full scope of the patient experience when thinking about cancer care. And one thing that struck me when I thought about these studies about parking costs is that when we see someone in our clinic, you know, when we open the door and we say, "Hello," they've already had to deal with all of these transportation barriers. They've had to navigate the parking deck and walk over. And so, when we're seeing them, they've already had some amount of small trauma, sometimes large trauma, related to just trying to get in the door. And I think that really nicely encapsulates the fact that there is a larger picture that our patients are experiencing that is not just me talking to my patient and outlining a treatment plan.

And one thing I think I heard kind of from both of you is that with these patient stories, you actually get ideas for research that you may not have actually thought of on your own. Again, your patient saying that they couldn't afford Christmas presents is such a compelling anchor for why what we do matters. And when we think about trying to explore things like quality of life or frailty, or the fact that, for example, the cost of a walker may actually be outside of someone's ability to pay, and they can't even afford their durable medical equipment. These are all part of the larger care experience for a lot of our patients.

Now, one aspect about this most recent JCO OP study that I particularly loved was the inclusion of the caregiver as an essential member of the healthcare team. Selfishly, perhaps, as a prior cancer caregiver myself, now a cancer widow, I find the caregiver voice to be really underappreciated and understudied. Shakira, do you mind sharing why you felt like this was really important to include caregivers on this study?

Dr. Shakira Grant: Sure. So, it came exactly out of the reason that you mentioned. Oftentimes when we think about research, especially within the cancer space, a lot of it is centered on the patient experience. And what I've learned through clinical practice and even working in the health policy space is that cancer is a disease that not only impacts the patient but it impacts the family around them, and that bleeds into financial issues and whether or not someone experiences financial toxicity. Now, especially in the health policy world, we hear a lot about medical debt and thinking about how that then gets passed on to other family members. So, it was critical for me and our team to really think about the caregiver because we saw them as being a central part of the cancer journey or experience. We wanted to capture their voices because so often their voices, their experiences are not taken into consideration.

And I think when it's coming to think about something like transportation in particular, it's key to remember that transportation is a core determinant of whether or not people are going to be able to access healthcare. And when you are older and you have disability and you're not able to operate a vehicle, that's one aspect of it. But then there's the financial piece of the transportation, which is paying for costs to uptake your vehicle, insurance costs, parking costs, and then the other costs that happen once you actually reach the cancer center. So, it was important for us to not only understand this from the patient perspective, but we do recognize, especially with older adult caregivers, they too are taking time off from work. That means lost wages potentially for them in order to drive their caregiver to the care recipient to the cancer center. And that can have a downstream impact on them. So, it's important to amplify their voices whenever we are talking about this type of patient-centered, or should I say, patient and caregiver or patient-care partner focused research.

Dr. Fumiko Chino: Now, Arjun, I saw that you recently published a piece in JAMA Network Open on time toxicity that similarly had qualitative interviews of patients, caregivers, and actually also clinicians. Can you also speak to the importance of including caregivers in research?

Dr. Arjun Gupta: Absolutely. Before that, just I want to acknowledge that my own clinical care has evolved over time. I think I was much more immature earlier. But in my earlier years of clinical practice, it was largely patient-focused. And over time, I saw firsthand the importance of having an engaged care partner if I wanted the patient to do well. So, if our primary allegiance is to the patient, I initially used to look at it as, "I need the care partner to be on my side so that if we say the neutrophil count is 0.1 and we need to come to the emergency department, we need the care partner to be able to drive the patient."

But over time, as I matured, the care partner became a distinct human being for me. And someone put it very beautifully that the care partner's suffering, unfortunately, often lives on even after the patient's death. And in my clinical space, which is often advanced GI cancers, that's not uncommon when the median survival for the patient may be one year or so on average. And so that's where this was motivated from. And when looking at time burdens faced by patients and their loved ones, a couple of themes came up prominently. Patients often brought up themselves that, "You know, my time is precious and so much of it is used up, but it's really my loved one who's suffering." They referred to their loved one's time loss as collateral damage. They often described it as, "I am the ball that's not allowed to drop." So, my care partner is juggling four different balls, and I'm the only one that's not allowed to drop. So, all of my care partner's balls are dropping.

And one more point I'd like to raise is we often think about a care partner in the singular. So, there's an index or a main care partner. But one of the other interesting things was how often the entire network of friends and family around that patient and the index care partner were affected, which was likened to this domino effect or a rippling effect.

And so, for all of our work, I think if we're talking about the patient, I think it's absolutely unfair and not applicable if we don't consider the care partner alongside patients.

Dr. Fumiko Chino: I love what each of you have highlighted: that this is an evolving paradigm of broadening the scope of what we need to focus on. And it kind of shocks me that this is a new concept, that suddenly, "Oh my gosh, the caregiver and the caregiver team actually matter." It's sort of like how we thought of quality of life as, "Oh my gosh, suddenly quality of life matters." It used to be just, "Oh, well, you're alive, so good luck with that," or "Survivorship matters." And so again, part of evolving research to be better is to really think about the full picture for our patients, and that includes quality of life and care teams and survivorship and end-of-life care.

Now, switching gears a little bit, Shakira, I know you're coming directly off of time within the federal government, working on health policy in the House Ways and Means Committee. Can you briefly speak to your experiences in DC and your work trying to bring some of these issues to the eyes and ears of legislators and how to prioritize national solutions to the affordability healthcare crisis?

Dr. Shakira Grant: Sure. So, in DC, my work on Ways and Means under our jurisdiction largely focused on Medicare. And with Medicare being one of the largest federal insurers, with just over 66 million, I believe, as of 2024, enrolled in Medicare plans, it really brought to light a lot of the complexities at play when it comes to thinking about the issues that the older adult population and those who qualify for Medicare based on disability status could face. And so that ran the range from thinking about health equity in everything that we did, which broadly encompasses thinking about social determinants of health such as transportation, as we're discussing, to making drugs more affordable for our older adults, as well as thinking about how do we safely bring innovative technologies and new therapies to the older adult population or Medicare beneficiary space, while ensuring that we are able to be focused on containing costs as much as possible - so, thinking about financial payment models and reimbursement.

When it comes to raising these issues, I would say from my experience in DC, I believe that regardless of which side of the aisle you sit, the health of the American people is always at the forefront of everyone, of every legislator. There's always ways to think about how do we improve the health of our communities, of the people that they are elected to serve. The way to do that, however, may look different depending on which side of the aisle you sit on. But I would say efforts that could be done that will help in this space are through the advocacy, especially through the work that ASCO continues to do, especially as it relates to drug pricing and addressing the drug shortages, raising issues such as affordability, healthcare access. Those voices together are really powerful and appeal to the broader legislative landscape to understand why this is so important, especially for your patient populations.

The other aspect of this is also related to just thinking about future changes as it relates to the current political climate and a lot of the federal actions that have been taken. I think overall, there still needs to be a push to make healthcare a lot more affordable. In addition to addressing the affordability issues of healthcare, there's also the access issues and ensuring that the 21 million people who have sought health insurance through the marketplace, that they continue to be protected and that they can still continue to have access to health insurance.

And then more recently, we've seen a lot of discussion around what is happening with Medicaid, and it would be remiss of me not to mention this because of the proposed $880 billion (with a B) in cuts that is proposed to this program. And so Medicaid is a key pillar. It provides insurance for those who are oftentimes the most vulnerable. It is one of the federal programs that actually addresses social determinants of health such as transportation by actually providing and covering transportation for its beneficiaries, as well as addressing other things such as food insecurity, housing insecurity. And so it's really critical when you think about framing social determinants of health, framing access to care, to think about Medicaid especially and proposed cuts and what that would mean for the most vulnerable among us in terms of being able to access the care that they need, in addition to the other programs that I mentioned.

Dr. Fumiko Chino: Now, Arjun, I know with some concerns about federal cuts to Medicare, Medicaid, there's been some idea that maybe there's a shift of focus towards state, institutional, other organizational commitments to try to fill the gap that maybe federal dollars are departing from. Do you have any thoughts about what we should be doing within our clinics, within our institutions, within our societies?

Dr. Arjun Gupta: Yes, I think just speaking at an individual clinician or health system level, especially as it pertains to transportation and parking specifically. So, what can I or we do in clinic tomorrow? We've actually been doing some qualitative interviews on this, on how to make people's life easier. And some of the things that patients and care partners have said are actually very, very simple. One of the first things is, "I wish my oncology care team was honest with me. We know you're well-intentioned. I know you're working in a broken system. But I was told, 'Oh, it's a quick infusion,' and then I was set up for a three-hour infusion, and then it ended up taking five hours. And I understand that you're all working hard, but just tell us if it's going to be five hours. And I can then plan my day and arrange childcare and things like that." And so, I just think being honest and vulnerable with our patients is super duper important.

The other thing is things like, "Do we really need to make the patient, plus minus their care partner, come in on a given day?" So, trying to coordinate care better. And one of the more specific solutions for that is people have suggested having a designated care coordinator or scheduler with them, a one-stop shop for scheduling, which cuts down so much of this time that's spent scheduling but also avoiding extra visits. So, while these longer-term policy issues are implemented and leveraged, I think there's things we can do every day. Is that CT scan, does it need to be done, or can it be on the same day? These can make massive, massive differences for our patients.

Dr. Fumiko Chino: Shakira, any last thoughts as we wrap up this podcast?

Dr. Shakira Grant: I just wanted to add to that because one of the key things I would sum up our study in showing is that, again, transportation is a core determinant of whether people are able to access healthcare. And we found, especially that older patients, those with disabilities, low income, and living in remote areas, these are the people who are facing the most significant challenges when it comes to accessing care because of transportation. And so, when you think about interventions, an approach could be, rather than thinking about population-level approaches that incorporate everyone, rather, it may be thinking about who are the high-risk groups amongst the people that are seen within your respective healthcare system, and then targeting interventions at the individual level as well as the healthcare system level, and then building up to thinking about community-level interventions such as rideshares, investing and appealing to policymakers.

But I would say we often think about policy changes as needed to really make a difference, but it really starts at the individual level, and you can then use that to build up to the policy because in order to develop a really great policy, it takes several years, sometimes up to a decade or more. And in the meantime, what we can be doing as clinicians, researchers, consultants, are focusing on the people within our immediate ecosystem and seeing how we can build strategic partnerships to address the issues that they're facing at those individual, interpersonal, healthcare system levels, and then leveraging that to build up robust policies.

Dr. Fumiko Chino: I love it. It's this idea of not losing the forest for the trees, but also taking the time and care for each individual patient in front of us. And it's a dual goal.

Arjun, any last thoughts from you?

Dr. Arjun Gupta: Just, I read a very interesting quote which I love. Someone said - I haven't found who said this, but they're clearly very smart - they said that, "With all of this AI and stuff, the biggest technological advance will still be more time with the patient." And I think in some of our work on time toxicity, clinicians, which is all sorts of people in healthcare, have persistently said, "I just wish I had more time." And so, I think as we think of frontline solutions, I think we need to respect our own time to be able to respect patients' and care partners' time.

Dr. Fumiko Chino: Well, thank you both for this wonderful conversation today. Many thanks to Dr. Arjun Gupta and Dr. Shakira Grant, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put Into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode, and until then, I encourage you to continue advocating for your patients, from parking vouchers to health policy solutions.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest

Fumiko Chino

Consulting or Advisory Role

Company: Institute for Value Based Medicine

Research Funding

Company: Merck

Shakira Grant

No relationships to disclose 

Arjun Gupta

Employment

Company: Genentech/Roche

Recipient: An Immediate Family Member

Transcript

Dr. Fumiko Chino:
Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an assistant professor in radiation oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

The incidence of early-onset cancer—new cancers in adults under the age of 50—is rising by 1% to 2% annually. Young women appear to be at particular risk, with cancer incident rates over 80% higher than similarly aged male counterparts. Collectively, that means that more patients are being diagnosed with cancer during their childbearing years. Pregnancy-associated cancer occurs in 1 in every 1,000 to 3,000 pregnancies and refers to cancer that is diagnosed either during pregnancy or within 1 year of delivery.

On today's episode, we'll be talking about pregnancy-associated cancer, with a focus on breast cancer, as it is the most common cancer diagnosed during pregnancy. This discussion will be based off of a JCO OP article published in late 2024 called "Multidisciplinary Management of Pregnancy-Associated Breast Cancer."

I'm excited to welcome both the first author of this review article and a patient advocate to the podcast today. They are both passionate about improving outcomes for people with breast cancer.

Dr. Erin Roesch is an assistant professor of medicine at Cleveland Clinic Lerner College of Medicine and a medical oncologist at the Cleveland Clinic Taussig Cancer Institute specializing in the treatment of breast cancer. She is involved in clinical trials research, and some of her specific interests include the care of young women diagnosed with breast cancer, fertility in oncology patients, and women's health and survivorship.

Julia Maues is a patient advocate working with researchers, clinicians, and other stakeholders to ensure research is patient-centered, innovative, accessible, and inclusive. She was working as an economist when she was diagnosed with breast cancer while pregnant in 2013. After delivering her son, she found out that cancer had already spread to her bones, liver, and brain. Julia co-founded GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization that connects and fosters collaborations between researchers and patient advocates. She is also active within the Metastatic Breast Cancer Alliance and helped write the ASCO guideline for brain metastasis.

Our full disclosures are available in the transcript of this episode, and we've already all agreed to go by our first names for the podcast today.

Erin and Julia, it's really wonderful to speak to you today.

Dr. Erin Roesch:
Thank you. I appreciate the opportunity to be here and discuss this really important topic.

Julia Maues:
Thank you for having me. It's very important to include the patient voice on this topic, and unfortunately, I have a personal experience with this.

Dr. Fumiko Chino:
Our topic today is pregnancy-associated cancer. Erin, can you give us a quick overview of the background for pregnancy and breast cancer? I know in the recent era, breast cancer rates for those under the age of 50 have been rising faster than for other cancers, up to 1.4% per year since the mid-2000s. I'd always thought that pregnancy-associated cancer was pretty rare, and so I was really shocked to read in your paper that for women younger than 35, 1 in 6 with breast cancer are diagnosed around pregnancy.

Dr. Erin Roesch:
Yes. So, a cancer diagnosis during pregnancy is rare, with the incidence, as mentioned, of about 1 in 3,000 pregnancies, with pregnancy-associated breast cancer, or PABC, representing about 7% of all breast cancers diagnosed per year. Among women under the age of 45, PABC accounts for roughly about 2.5% to just over 6% of breast cancer cases. And for women less than 35 years, this rises to about 15.5%.

Studies have shown a rise in PABC in recent years, and this is anticipated to continue with the trend of delayed age at childbearing. In regards to the pathophysiology of pregnancy-associated breast cancer, various hypotheses have been proposed to kind of try and shed more light on how this occurs and the driving factors for PABC. So these include hormonal changes that occur during pregnancy and lactation, immunologic changes that can lead to the immune tolerance of tumor cells, and also breast tissue involution that occurs after delivery and breastfeeding, which can lead to a proinflammatory state.

In regards to risk factors, these include a positive family history, which is one of the strongest risk factors for breast cancer development, this includes pregnancy-associated breast cancer, pathogenic germline mutations—specifically BRCA1 or 2—and older maternal age at time of birth. We also know that breastfeeding has been shown to have a protective effect against breast cancer development.

Dr. Fumiko Chino:
So what I'm hearing from you is that just given the incidence rising in younger people and also delayed pregnancy, that this is really something that we're unfortunately going to be facing more and more frequently in our clinics and something that patients unfortunately will find that they have to face as well.

Dr. Erin Roesch:
Yes, yes, I think that's accurate. And just again, I think points to the importance of awareness of this particular topic.

Dr. Fumiko Chino:
Now, Julia, your lived experience in this space is really invaluable. Do you mind sharing it with us?

Julia Maues:
Yeah, of course. I was pregnant at 29, and I found a lump in my breast. I had an excellent OB-GYN and team, and they took it seriously. I think she wanted to watch it for a few weeks, but as soon as it didn't go away, she ordered an ultrasound, and that turned into a biopsy, and that turned into a cancer diagnosis.

I lived near a comprehensive cancer center. I had multidisciplinary care, really excellent team, and was treated with chemotherapy during the pregnancy, which was very surprising to me and hard to accept. But they did provide me with a lot of evidence that that is the best treatment for both my baby and me. And so I did four cycles of Adriamycin-Cytoxan during the pregnancy and delivered my son at 37 weeks. He was healthy and full of hair, even though I was bald. That was very important, I think, for many reasons, but it showed visually that the placenta did its job and he was protected.

After he was born, I could do scans that I couldn't do while pregnant. I had a lot of back pain and things that were thought to be pregnancy-related, or maybe they knew, and they just didn't go there because it really wouldn't have made a difference at that point, like, the treatment couldn't be any different. But I did that scan and found out that it was metastatic, and that changed the treatment that I did after the pregnancy, and instead of eventually surgery, I just stayed on systemic therapy for that long. And spoiler alert, this is 12 years later. That baby is in sixth grade and thriving. And I am very grateful for the privilege that I have to have received such excellent care and have access to the treatments that I have had, and also the luck to have had good response to treatments.

Dr. Fumiko Chino:
I love how you've taken your story and the successes, but also the horror and the terror, and really used it to galvanize your life in a mission to try to improve patient care for others. So I've always really thought that was phenomenal in terms of your mission and your drive.

Julia Maues:
Thank you. I'm very, very happy that it helps other people, but selfishly, it helps me to deal with my own difficult experience, and it's been a way to make something good out of this.

Dr. Fumiko Chino:
I feel very aligned with you on that in terms of my own personal story as a caregiver. It's one of the reasons why I became a physician. So I feel like you and I have a common touchstone there. And I think so many people in medicine and so many patient advocates are really trying to give back into a system to try to improve it for all because of either the ways that it helped them or the ways that they thought that it could be doing better. So thank you for sharing that with us.

Now, Julia had mentioned that the staging scans were delayed until after delivery due to some appropriate safety concerns. And I certainly know that those diagnosed during pregnancy often have diagnostic delays. Erin, do you mind discussing what delays may occur in pregnancy-associated breast cancer and if there are any solutions to improve those delays?

Dr. Erin Roesch:
Sure. And I'd like to echo and certainly, you know, thank Julia for sharing her story. And I think as an oncologist, we learn so much from our patients, and so it's really, really important for us to understand, to be able to appreciate everything you've gone through. So I just, I really thank you for that.

So in terms of, you know, the delays that we see—and I think, Julia, your story through this really kind of outlines much of what we see in terms of some of these delays and challenges related to the diagnosis and the workup of pregnant women with suspicion of breast cancer. So although the majority, about 80%, of breast cancers or breast masses, rather, detected during pregnancy will be benign, any palpable mass present for a couple of weeks or more in the breast or axillary region should really be clinically investigated, you know, as your doctor did. Additionally, any other breast changes—less common things such as an asymmetry, thickening of the skin, redness of the skin, nipple changes—those things should also be investigated, you know, as they raise clinical suspicion.

Pregnancy-associated breast cancer often remains undetected in pregnant women until later stages due to potentially symptoms being masked by the physiologic breast changes during pregnancy. Studies have shown that a relatively high proportion, you know, over 80%, of pregnancy-associated breast cancers are self-palpated. We know that later stage at presentation and a delay in care can lead to an inferior prognosis or affect someone's prognosis.

So I think in terms of the challenges, in terms from a diagnostic evaluation standpoint, typical imaging modalities that we use for breast cancer, we know some can have harmful effects on a growing fetus. So the evaluation should begin, as Julia mentioned, with an ultrasound. That would be the initial gold-standard diagnostic test. And then subsequently, a mammogram with abdominal shielding can and should be used to provide additional details regarding the breast mass.

In terms of systemic staging, so I think again, as Julia pointed out, the traditional evaluation for metastatic breast cancer typically includes CT scans with IV contrast of the chest, abdomen, pelvis, and a bone scan or a PET scan. However, these imaging tests should be avoided during pregnancy, particularly during the first trimester, due to the harmful exposure of radiation and IV contrast to the fetus.

In regards to some of the solutions, I think from a systemic staging standpoint, alternative imaging can be used. So when indicated or appropriate, things such as a chest x-ray with shielding, an ultrasound of the liver, an MRI of the spine without contrast could also be considered, again, in the appropriate setting. But I think, you know, Julia certainly highlights the challenges that we face from a diagnostic standpoint.

Dr. Fumiko Chino:
Julia, you had said something probably that was the most important, which is that you felt the mass and that your physician actually took it seriously. And I certainly have heard from other patients that when they were pregnant and they felt something, it was sort of just 'pooh-poohed', for lack of a better term, as, you know, normal changes in the breast, and it wasn't followed up to the extent that it should have. Do you have anything to add in terms of delays? I know you are certainly very active in the advocacy community, so I feel like you've probably heard every good and negative story about delays to diagnosis or care.

Julia Maues:
Yeah, unfortunately, we hear these stories all the time. The clogged milk duct, which may be very plausible, but needs to be investigated, right, is not always the case. And unfortunately, anecdotally, and I know you all have been part of evidence on this, women that are Black experience this at a much higher rate. And then we see younger women with doctors that just tell them that, "Women your age don't get breast cancer."

Dr. Fumiko Chino:
Which is patently false, as we know, because the rates of breast cancer in younger women are rising. So I feel like we need to be standing on top of rooftops trying to make sure we're advocating for our patients and educating our colleagues about the early-onset cancer risk.

Julia Maues:
And I'll say one more thing that I think patients also have a wrong understanding of this statistic about pregnancy protecting from breast cancer after menopause. The only thing that translates is 'pregnancy equals lower rate of breast cancer', right? So that is not necessarily the case while you're pregnant or in the short years after the pregnancy. It is a statistic about postmenopausal breast cancer, which won't affect the pregnant person for many years.

Dr. Fumiko Chino:
Julia, this review highlights the role of the multidisciplinary team for optimal management of pregnancy-associated breast cancer. And from the article, it says, "At the time of diagnosis, multidisciplinary teams should be consulted, including breast surgery, plastic reconstructive surgery, medical oncology, radiation oncology, maternal-fetal medicine, genetics, and psychosocial services." Can you speak to who was involved with your care, including what really worked well in this incredibly stressful situation or lessons learned for what could be improved? I know you said you did have the benefit of a comprehensive cancer center and a multidisciplinary team.

Julia Maues:
Yes, absolutely. A team that came from many angles at this problem was very important. I did see a surgical oncologist, a radiation oncologist, a plastic surgeon, the medical oncologist, of course. And then I had two OB-GYNs, my first OB-GYN and a high-risk OB-GYN, and I did see genetic counseling. And I think after those first appointments, the surgeon and the radiation oncologist and the plastic surgeon didn't play a role. They were going to come back into my care after the pregnancy; that was the plan. But the OB-GYN, and especially the high-risk OB-GYN, was very important. And the fact that they were in touch with my medical oncology team and they were complementing each other in terms of medications and what treatment I needed, that was very important.

Dr. Fumiko Chino:
Erin, do you have anything to add in terms of coordinating these large teams? I know that the medical oncologist often works as sort of the quarterback in this scenario for these teams.

Dr. Erin Roesch:
Yes, and that's exactly how I typically describe myself to patients, is kind of as that quarterback. I think that Julia's description certainly highlights the importance of multidisciplinary care, and it's really crucial for pregnancy-associated breast cancer. And it's important to recognize that it's not a one-size-fits-all approach either, and that not all patients' needs might be the exact same. But that being said, it's helpful to have, you know, an algorithm that outlines the general steps, diagnosis, and management of our patients with pregnancy-associated breast cancer. And it's really important—it's an overwhelming time for patients and their families. So it's really, you know, essential to make sure that our patients have knowledge of and access to all of the resources that are available, you know, during their diagnosis, treatment, and in survivorship. I think that again, just stressing that multidisciplinary care from the beginning is really key.

Dr. Fumiko Chino:
That segues nicely into the next topic, which is: I really found the figure in your article to be particularly helpful as a flowchart for decision-making in pregnancy-associated breast cancer. How do you approach shared decision-making, patient autonomy, and informed consent with your patients when faced with some of these really heartbreaking decisions?

Dr. Erin Roesch:
So, you know, just as I said, it's certainly, you know, it's very individualized, but it is very helpful to have a guide that we can follow and that we can also use for educating other providers on what are modalities that are safe during pregnancy, what we have data on, where we're lacking, et cetera. So I think that when I talk with my patients in this type of situation, you know, I think open lines of communication, transparency, super important. And I think recognizing that breast cancer diagnosed during pregnancy often occurs during a time when a woman is figuring out their life plan. They could be finishing school, family planning, you know, career goals, establishing relationships, just to name a few things. So it's helpful to be aware of these things when we're counseling our patients so that we can better really appreciate, understand their goals and, as much as possible, help them achieve their goals while also effectively treating their breast cancer. So I always really, really strive to involve my patients in the decision-making regarding their care, but also advise them that I'm there to provide full support and whatever information that I can to be helpful.

Dr. Fumiko Chino:
I love that thing to highlight—that cancer doesn't define someone's existence, and they were a whole human being before their cancer diagnosis, and they should be a whole human being after their cancer diagnosis. And so making sure that we are talking to a person, not to a cancer diagnosis and a treatment plan. It's an individual on the other side.

Now, Julia, I know that you said that your stage IV diagnosis came after you delivered. I'm sure that there was a shock and horror related to that. Do you have anything to add in terms of the multidisciplinary team or how it pivoted once you got that diagnosis?

Julia Maues:
I completely agree with the 'quarterback' name to the medical oncologist. They definitely have, even today, this role in my life, and I definitely benefited from really wonderful quarterbacks in my years. But I think another very important connection there is being able to connect to other patients with a similar experience. I did - at different times, I was able to connect to people who had just had a baby after treatment during pregnancy, or who had a child that was maybe a little bit older and they were thriving, and just knowing that that was a possibility or a likely possibility for my child, even though I was making him go through these treatments while inside me.

Dr. Fumiko Chino:
Now, pregnant women, human fetuses, and neonates have additional protected status under the federal government that mandates special IRB review. This means that pregnant women are often excluded from research, often without actually clear justification, even when the research really poses minimal risk. Erin, how do we improve the body of evidence to support best care for patients with pregnancy-associated breast cancer, understanding some of these concerns?

Dr. Erin Roesch:
Yes, so I think it is really important to utilize the research means that we do have. So an example of this could include retrospective analyses, you know, looking at registry data. We can really gain important, valuable information this way. Additionally, learning from thought leaders in this space and experts in this field can help providers and patients better understand the data that we do have and where our gaps may exist.

I think, furthermore, various institutions have niche programs that are dedicated to education and research for young women with breast cancer and, within that umbrella, pregnancy-associated breast cancer. So it's really important, I think, to be aware of those resources as well that do exist.

Dr. Fumiko Chino:
You really highlighted something important, which is that in this situation of pregnancy-associated breast cancer, it likely is best to go to a specialty center, you know, a comprehensive cancer center of some variety, or a center of excellence so that you can really rely on both the expertise of the team but also their capacity for building that multidisciplinary team that is, I think, really required to treat a patient with cancer and pregnancy well.

Now, Julia, I personally see some parallels here with exclusions for people during pregnancy and also the exclusions for metastatic breast cancer from research studies. Do you mind speaking about that? I know you've been a strong advocate about inclusion.

Julia Maues:
Yes, absolutely. We see a lot of clinical trials that include metastatic breast cancer patients when it comes to the actual treatment and the new drugs. But when it comes to survivorship trials, and let's say, what is the effect of exercise on your outcome? Patients with metastatic breast cancer are often excluded. And we are surviving too, right? We need to be studied in that scenario as well. And I think we're fortunately seeing some change in that. And there are a few trials, for example, open right now looking at diet and exercise for specifically metastatic breast cancer.

Dr. Fumiko Chino:
It's amazing to think about how you've really straddled both high-risk groups, you know, the pregnancy-associated breast cancer, metastatic breast cancer, and really dedicated your life to making inroads and positive changes for both of these communities. So I really am so grateful for you for that.

We are sort of wrapping up this podcast. I wanted to give a little bit of space at the end to have any open topics, if there's anything that we feel is under-addressed or unaddressed in this topic. I know that we could probably spend, you know, five hours talking about it.

Julia Maues:
I will say one thing that is perhaps the most difficult decision. When I discovered my diagnosis, I was very happy to be pregnant, but I was faced with the question of, I now have a disease that is life-threatening. Am I going to be alive by the end of this pregnancy? And in order to be alive by the end of this pregnancy, do I need to terminate this pregnancy? I think that is a question that was the most difficult one during that moment and is one that I discussed with my team. And fortunately, in my case, it was possible to give me treatment during the pregnancy and still not harm my baby. But I think this is the first thing that we're faced with at that moment of the diagnosis.

Dr. Fumiko Chino:
And I think that concern is certainly even more relevant in the climate where, depending on where you live, that may not even be an option. And even, I have definitely heard some concerns about even chemotherapy while being pregnant could be potentially something that would be at risk. Erin, do you have anything to add?

Dr. Erin Roesch:
Yeah, no, I think that's a valuable point too, is that again, it's a very, very challenging, scary time at initial diagnosis. And just like Julia mentioned, many women are very happy they're pregnant. And even to Julia's point earlier about receipt of chemotherapy during pregnancy, you know, many women might not think that that's possible. We have data that has shown relative safety of certain chemotherapies during pregnancy, you know, after the first trimester. And so I think it's important that again, with the shared decision-making, that women know all of this information so they can process and come to the best decision for themselves.

So, and I think also, not that we can predict the future—I always tell my patients I wish I had a crystal ball that I could tell what was going to happen in the future for people. But I think that we've had a lot of advances in terms of breast cancer treatment, and this includes for metastatic disease. And so our patients are living longer and living better. So I think that's important to remember too. And just again, make sure that we, as much as possible, have these conversations upfront with what we know and what we don't know so our patients can feel supported through this process.

Dr. Fumiko Chino:
That's a really good, positive note to end it on. So I'm so grateful for your time. Thank you for this wonderful conversation today. Thanks to Dr. Roesch and Ms. Maues, as well as our listeners, for your time today. You can find the links to the papers that we discussed in the transcript of this episode.

If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put Into Practice's next episode. Until then, please stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Conflicts of Interest:

Erin Roesch:

Honoraria

Company: Intellisphere

Consulting or Advisory Role

Company: bioTheranostics

Company: MDedge

Company: Seagen

Julia Maues:

No Relationships to Disclose

Transcript

Dr. Fumiko Chino: Hello, and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity.

Breast cancer treatment has made significant strides in the past century, with the five-year survival rate rising from less than 5% in the early 20th century to around 90% in the present day. In today's episode, we'll be discussing the shift in breast cancer management from reducing local-regional recurrence and improving breast cancer mortality to deintensification, shared decision-making, and improved quality of life. This discussion will be based off of a JCO OP editorial published in late 2024 called "Contextual Framework for Understanding Treatment De-escalation in Patients with Breast Cancer."

I'm excited to welcome two breast cancer experts as guests today: the first author of this editorial and radiation oncologist, as well as a health services researcher and breast surgeon. They're both engaged in research to improve outcomes for breast cancer, including treatment optimization.

Dr. Atif Khan, MD, MS, is a full attending breast cancer disease site leader and Service Chief in the Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center. He is also on the steering committee of the Clinical Research Innovation Consortium, as well as on the Research Council at MSK. Dr. Khan is the chair of the breast section of oral examiners for the American Board of Radiology and is active in NRG, helping develop and lead key clinical trials to optimize radiation delivery for breast cancer. Dr. Khan is also a translational science investigator of novel radiosensitizers.

Dr. Oluwadamilola "Lola" Fayanju, MD, MA, MPHS, is the Helen O. Dickens Presidential Associate Professor and Chief of the Division of Breast Surgery at the Perelman School of Medicine at the University of Pennsylvania. She is also Surgical Director of the Rena Rowan Breast Center at the Abramson Cancer Center, Program Director for Implementation Innovation at the Penn Center for Cancer Care Innovation, and a Senior Fellow at the Leonard Davis Institute of Health Economics at Penn.

Our full disclosures are available in the transcript of this episode, and we've already agreed to go by our first names for the podcast today.

Atif and Lola, it's wonderful to speak to you today.

Dr. Atif Khan: It's a pleasure to be here. Thank you for inviting me, Fumiko.

Dr. Lola Fayanju: Yeah, thanks for having me.

Dr. Fumiko Chino: The topic today is treatment de-escalation for breast cancer, loosely based on the editorial that Atif wrote in JCO OP outlining a conceptual framework, which is primarily focused on local-regional therapies, i.e., radiation and surgery for breast cancer. The concept of rightsizing treatment has really been developing over the past three decades, spearheaded by surgical de-escalation. Lola, do you mind giving me a brief overview of surgical de-escalation as you have seen it throughout history and as currently realized in your practice?

Dr. Lola Fayanju: Happy to. So, you know, it's one of those things where I think increasingly we recognize that breast cancer is a heterogeneous condition that shares an anatomical space. And with that refined understanding of treating breast cancer, we're no longer using a very blunt and large hammer to deal with what is actually a constellation of nails. So originally, when people used to treat breast cancer, the idea was that you wanted to take as much tissue as possible. And this originated the Halstedian mastectomy, which was a radical mastectomy that often involved removal of not only all the breast and axillary tissue but also the pectoralis muscle, even some accessory nerves, that really left people with incredibly deformed body habitus as well as compromised function. And in part, that was not an unreasonable approach given that disease was often presenting in a locally advanced fashion.

However, as we have been increasingly able to detect disease at an asymptomatic, pre-palpable state, but also as our ability to treat disease at a systemic fashion has become more effective, we've been able to move from the Halstedian mastectomy to then the modified radical mastectomy, and then ultimately to even less axillary surgery, as well as less breast surgery, such that there was the advent of the lumpectomy pioneered by Bernie Fisher in the 1980s, as well as sentinel lymph node biopsy pioneered by Armando Giuliano and Don Morton in the 1990s and early 2000s. And what this allowed us to do, again, is to achieve similar if not better outcomes, because we were again catching disease at an earlier state thanks to screening mammography, but also able to provide more personalized, less morbid care that focused on just the cancer at hand with the additional adjuvant therapy of radiation to provide comparable survival to mastectomy.

What this has allowed us to do is also think about the order in which we do treatment, that is allowing people to potentially get systemic therapy first in order to convert from a more morbid procedure to a smaller, less morbid procedure. So, we've made a huge number of strides both with regards to surgery in the breast as well as surgery in the axilla, and that's been facilitated by a combination of knowing more about disease, being able to be more systemic and holistic in its treatment, and also recognizing that more is not always more. The last thing I will say is that we've also been aided not only by the adjunct radiation and systemic therapies, but also by the ability of our radiologists to localize pre-existing cancer such that we can target the area and just the area of concern, whether it's through targeted axillary dissection or through sampling a previously positive area of the breast, such that we can again be more selective in terms of the surgery people get after systemic therapy.

Dr. Fumiko Chino: Thanks for that great overview, and I really love it how you have highlighted that it's all of these advances that allow us to customize the treatment to the individual. So it's not one size fits all with cancer care. We're really trying to make a customized plan and really rallying all of the modern technologies to make sure that we're rightsizing the treatments for the individual. And I think that provides a lot of benefits for patients.

Atif, can you highlight some of the key steps to de-escalate radiation for breast cancer?

Dr. Atif Khan: I think thematically, we're seeing a very similar sort of trend in radiotherapy. Just as a reminder, radiotherapy is a critical component of breast conservation therapy and also in the post-mastectomy context for high-risk patients. Radiation has been shown to sterilize or reduce the risk of microscopic residual, reduce the risk of local-regional recurrence, and in high-risk contexts, you know, by extension, reduce the risk of all recurrences and even improve survival, for example, in the seminal post-mastectomy radiation therapy trials.

Now, we existed in a time when there was perhaps only one right way to do radiation therapy, and that's not the case now. We have many different ways that we can deliver radiation therapy. And that's important because our, as Lola said earlier, our understanding of different risk strata of breast cancer has also improved, meaning we can stratify breast cancer patients into low risk, intermediate risk, high risk, maybe even very low risk. And therefore, we can tailor the intensification of our local-regional treatments to match the background risk that may exist for that particular patient.

Now, if we consider five weeks of whole breast radiation or five weeks of post-mastectomy radiation to sort of be our historic norm, we now know that we don't have to protract the course of radiation out like that. We can treat that same target volume, for example, the whole breast, with a shorter course of radiation that generally is given over three weeks. Now, I do want to pause here for one second just to clarify for everyone listening: taking five weeks of whole breast and doing that over three weeks is not necessarily a de-escalation per se, because really the same biologically effective dose is being given. It's just being given faster. So it's not really a treatment deintensification or de-escalation per se. Now, it is less disruptive to patients, it might be less, say, financially toxic, for example, in terms of like missed days of work, etc., but it's not a de-escalation with respect to the intensity of the treatment. It's just the same treatment being given shorter, but we know that it's safe to do that.

In contrast, partial breast radiation is, in fact, a de-escalation because now our target volume is no longer the entire breast, rather, we're just treating a part of the breast, that part of the breast where the risk primarily is, which is in the index quadrant where that original breast cancer was. And at the, let's say, at the low end of the risk spectrum, we now have very good evidence, you know, 14,000 randomized women, demonstrating that, in fact, partial breast radiation in those contexts is just as good as whole breast radiation. And I always sort of half-joke that whenever this treatment is possible, we should use it because for a fibroblast sitting in the breast somewhere minding its own business, a day without radiation is a good day, right? So if we can spare that treatment to uninvolved normal cells, we should try to do that.

And then, of course, the ultimate de-escalation is to identify patients who don't need radiation at all and just omitting radiotherapy. And really across the risk spectrum, whether it's in breast conservation or whether it's in PMRT/regional nodal radiation, we are seeing the emergence of these different types of treatments, meaning kind of like the high-risk treatment, the intermediate-risk treatment, and then at the very low end of the risk spectrum, no treatment at all. But that's sort of the practice that we're living in now, and I think it's a good one. We're making progress.

Dr. Fumiko Chino: I appreciate that. The whole idea is if we can potentially omit treatment to certain areas of the body or if we can omit it completely, we're certainly doing a favor for our patients if it's not going to increase their overall risk. We had talked, I think between the two of you, about some of the benefits of potentially omitting or reducing morbidities from, for example, surgeries or comprehensive treatments. Atif, do you want to take it first? What are the actual de-escalation risks? What are we potentially putting at risk when we talk about de-escalation or deintensification?

Dr. Atif Khan: Yeah, great question. I mean, I think the primary risk, which is, you know, a scary thought, is that we de-escalate or we do it too quickly or we find that, in fact, reducing the intensity of treatment leads to an increase in the recurrence risk of breast cancer. That's a very scary thought. I will say that this process of creating options, you know, treatment options, de-escalated treatment options, has been quite successful. For example, I'll open it up to Lola and you, Fumiko, but I can't really think of a clear example in which the de-escalation trial went in the wrong direction. Like, they've all sort of gone in the same direction, which is that the de-escalation or deintensification studies have generally been successful, meaning that we were able to preserve the excellent oncologic outcomes that we are used to seeing with less treatment. That's a testament to kind of how careful, you know, the scientific process is with respect to these practice-defining trials. They go through multiple levels of scientific review. It's a multidisciplinary group of individuals that's looking at this. And I would say the endeavor overall has been quite successful.

Dr. Fumiko Chino: Lola, anything to add?

Dr. Lola Fayanju: Yeah, I think when we're thinking about the risk of de-escalation, I would put them into three categories of risk. So, there are risks to the individual, that is, you know, we're actually de-escalating in the wrong person because we have an insufficient amount of information about whether they meet the criteria for de-escalation.

There's, I think, risk to the population in terms of are there groups of people who are systematically not benefiting from the de-escalation or who should not be benefiting from de-escalation because again of an underappreciation of how disease might work in that group or because the practice patterns where those people are getting care will not be amenable to de-escalation ultimately being of a good thing for them because they're not getting the other components of care that frankly are needed for de-escalation of one modality.

And then three, I think there's a risk to our collective knowledge about cancer because when we're not collecting information about what happens after six weeks of radiation or how many lymph nodes are positive, we just know a little bit less about the natural history of the disease and the natural sequelae of treatment. Again, that knowledge may be worth forgoing given the morbidity to patients and the non-benefit with regards to recurrence and survival, but it's real. It means that our retrospective reviews look different. It means our ability to have preliminary data for other types of things look different. With regards to the populations, it means that whenever we're thinking about de-escalation, we need to think hard about how to translate what we see on the podium at San Antonio or ASCO into clinical practice. And that requires, I think, more care than is often administered.

Dr. Fumiko Chino: Yeah, I'll quote directly from the manuscript of the editorial that we are basing this podcast on, and it said basically, "American women ascribe a high utility to remaining without evidence of disease." And that really sticks with me in that, even though there may not be a survival benefit, an increased risk of recurrence is not without a personal, financial, and physical burden on patients, even if that difference is small, it may be meaningful for the person in front of you.

Now I'll also shift focus slightly and just mention that we're primarily talking about local therapy here, but I'd be remiss to not highlight that there are gains in de-escalation for systemic therapies from, for example, RxPONDER, allowing us to safely omit adjuvant chemotherapy for many node-positive patients; B21, showing that monotherapy with radiation may be actually even better than tamoxifen monotherapy with no metastatic or survival differences; and of course, the PERSEPHONE trial that demonstrated that six months of trastuzumab was non-inferior to 12 months, although, granted, there were many caveats leading to poor adoption of this in practice.

Now, Lola, I know you've already mentioned this, but there are maybe some concerns that you see about broad adoption of these practices into, for example, surgical de-escalation. Based on what I know is stark disparities in clinical trial enrollment in certain populations or in maybe even clinical trial protocol adherence, are there any specific populations that you want to highlight that might be hesitant to apply this clinical trial podium data to?

Dr. Lola Fayanju: That's a great question. So, as an example, when we think about the SOUND trial, which was recently published and demonstrated that in women with early-stage breast cancer who were undergoing breast-conserving therapy and had normal axillary evaluation prior to surgery, that sentinel lymph node biopsy could be safely omitted without detriment with regards to long-term outcomes, you need to think about the context in which that preoperative ultrasound is being done. So, at different institutions, whether or not an ultrasound is routinely done, whether or not that ultrasound is done prior to biopsy, all of these things have implications for how likely you are to have a false positive after biopsy (so it's preoperative, but it's post-biopsy) and also what you're going to do about it, whether you're going to act on it, whether you're going to go ahead and proceed with sampling that node if it looks enlarged, putting something in it that means you retrieve it. If it demonstrates a small amount of cancer, potentially consigning someone to either an axillary dissection or preoperative systemic therapy that they might have forgone had you had the full picture of surgical pathology.

So that's just one example of how the context in which implementation occurs is really important because you have to take into account local practice patterns and what that means with regards to how we interpret the data that was used in the trial to then implement this practice in real life.

With regards to populations that need to be considered, I think in terms of centering equity, both domestically but also at a global level, thinking about, for instance, how we stage the axilla, how we map the axilla. What's the facility for lymphoscintigraphy as well as for localization of a previously positive node? So, there are many countries, many quite wealthy countries, in which use of radiocolloid is not routine, where it is primarily that people are using some type of tracer blue dye, for example, and therefore would not strictly be meeting the criteria for optimal sentinel lymph node mapping that would allow for a low false negative rate after neoadjuvant systemic therapy.

In the United States, we might be in places where you have patients who are having surgery with people who don't do that much breast surgery and who are less likely to have a successful and correct yield of lymph nodes at time of sentinel node biopsy. And so, you know, these are people for whom there might be actually clinically significant disease that's being left behind if not being done by someone who has a lot of experience working with dual tracer as an opportunity to localize a preoperatively positive lymph node. So again, thinking about both the availability of materials as well as the expertise of the local practitioners means that people in less or differently resourced settings may not benefit from implementation in a way that actually leads to appropriate outcomes.

Dr. Fumiko Chino: Yeah, I love it how you highlight that there's global differences, but there's also just in the US differences in capacity and skills within doing these, some of these presurgical and surgical evaluations. All three of us work at world-leading cancer centers, and I recently just transitioned from two top cancer centers in the United States, but I was actually kind of shocked about the differences even between the two major centers about how we do ultrasounds, for example.

Now, Atif, I've noticed that some providers don't really feel comfortable combining the information from various de-escalation trials in practice, i.e., so for some patients that might have had sentinel lymph node biopsy omitted per SOUND, they may be less likely to actually get PBI and instead, you know, prefer to treat whole breast radiation to cover the axilla. So, in this respect, it seems like we're kind of taking like one step forward, one step back. And are we de-escalating surgery to just escalate radiation?

Dr. Atif Khan: Fumiko, I agree with you. It'd be very counterproductive if we found that de-escalation in one domain was leading to escalation in another domain. I think the example you cite is a good one. If we are moving to a world without sentinel node biopsy and let's say clinical staging only, does that then mean that we have to, for example, give up on partial breast irradiation and treat everybody with whole breast radiation on the notion that low axilla, for example, is going to get some therapeutic effect? And I would submit for everyone's consideration that no, we in fact should not do that. We spent years developing the partial breast irradiation literature. We know that PBI has less acute toxicity. In every single trial, it has less fatigue, and it actually has less late toxicity in some studies, which is not surprising because remember, you're treating less tissue, you're treating less stuff, and that's a good thing.

Now, coming to SOUND and INSEMA, on the sentinel node arms of both of those studies, the rate of additional positive nodes is very- around, 10%, and that's pretty low. So I would submit for everyone's consideration the idea that if your patient is node-negative by SOUND criteria, let's say, right? They're very likely to be pathologically node-negative. And you can actually treat them as if they were pathologically node-negative. And that's kind of how we've adopted the findings of both SOUND and now also INSEMA from San Antonio, meaning that if a patient is eligible for PBI based on everything else, and she is node-negative by SOUND criteria, then we will offer them PBI in exactly the same way as we were before these trials were reported.

I also wanted to make one observation on your prior comment, Fumiko, if I may, about the de-escalation of systemic therapy. One thing that has been on my mind quite a bit is, particularly with, let's say in the elderly group where we have been struggling with kind of like the best monotherapy, right? Should it be five years of endocrine therapy? Should it be a short course of radiation, or do patients really need both of these treatments? And this is topical because the EUROPA trial, one of the endpoints was reported at San Antonio, the quality of life endpoint. Not surprisingly, a short course of radiotherapy was sort of associated with better quality of life than the endocrine therapy.

But I think we may be missing one potential opportunity in this sort of idea of like, we have to either do the radiation or the endocrine therapy, which is we might be able to give a little bit of systemic therapy and a little bit of radiation therapy. This line of investigation or line of thinking doesn't really exist right now. Like that conversation is interesting. So for example, can we give, for number one, can we go from AI back to TAM, right? Because AIs are just, there's just, the quality of life is worse. And can we give a lower dose of the TAM, monitor for compliance, and then give a little bit of radiation, you know, let's say PBI or something? And maybe that's the way to do that. And you could take that idea and you could apply it across different contexts even in breast cancer. And I'll note that that is how kind of the Hodgkin's lymphoma treatment evolved over time. At the low end of the risk spectrum, they kind of said, "Okay, a little bit of chemo and a little bit of radiation is better than just giving a lot of chemo or certainly a lot of radiation." And you know, that worked. And I think at the low end of the breast cancer risk spectrum, we might start thinking about that kind of line of investigation.

Dr. Fumiko Chino: You want to 'Goldilocks' this situation. You want to try to find something that's just right. And I love that. And I think that sort of out-of-the-box thinking is very helpful when we think about how omission seems very clean, "you just don't get this," but deintensification, simultaneous deintensification, I think has a lot of appeal there.

Lola, do you have anything to add about that?

Dr. Lola Fayanju: I have to acknowledge the bias of three local-regional therapists on this podcast, I'm outnumbered by our two rad oncs. But just wearing my medical oncology ally hat, I think one of the challenges is also that for many of them, the ability to prescribe effective forms of systemic therapy, including CDK4/6 inhibitors, for example, is sometimes predicated on information we obtain at surgery. So, when we think about implementation, which is really, you know, an area of research for me, whether it's trying to implement the SOUND trial, again, in an institution where everyone's getting an ultrasound prior to biopsy, absolutely. But in an institution where either it's completely ad hoc, so it's kind of the 'wild, wild west', you have no idea from radiologist to radiologist who's doing ultrasound before or after biopsy, and also frankly, what is the kind of false negative rate at that institution, recognizing not everyone's working at the kind of places we work at. Are we doing patients a disservice?

But then, in addition, thinking about working with insurance companies, right? If we're trying to say, "Okay, we are no longer going to do sentinel node biopsies," but that's actually required for the administration of certain medications, we put our medical oncology colleagues in a bad position in terms of their ability to actually get certain types of treatments paid for and approved. And so again, thinking about the consequences of our choices for patients, I think it really points to the fact that multidisciplinary consultation is increasingly going to be needed because we can't de-escalate everything. I think we all agree most cancers need to be treated in some fashion. But, you know, if we take away surgery, we take away radiation, we take away systemic therapy, suddenly we have a cancer that's just sitting there. And for some people, that's the right thing. Again, thinking about shared decision-making, for some patients with other morbidities and/or older age where they're unlikely to have any kind of meaningful threat from disease being left in place, well, that is the right thing potentially. But for a majority of our patients who actually want some form of treatment, I think we do need to think about the implications for our other prescribing providers, what that means, how we can help them, even as the clinical trial data suggests that there aren't major changes in adjuvant therapy or radiation prescription when you omit sentinel node biopsy, at least in the trials that have so far been shown.

Dr. Fumiko Chino: This is a nice segue to my last point, which is to talk about how these discussions of de-escalation, these decisions should really be made after the full multidisciplinary input. And yet, I feel like I've seen our specialties get increasingly disconnected in this kind of era of Zoom conferences. There seem to be less face-to-face meetings. There seems to be decreasing space for our co-shared clinics. And I just wanted to ask both of you what you think our responsibility is to each other and to our field to ensure that we're really working on these things synergistically.

Lola, you just mentioned some of your thoughts, but do you mind speaking about the multidisciplinary conversation or even how we're designing research?

Dr. Lola Fayanju: I think, with regards to the research, I'll start with that first, it means that, I think we're less going to have trials that fit in certain kind of cooperative groups that are more geared towards radiation or what have you. I think, increasingly, we should be having MPIs, you know, co-PIs who are from different modalities. I think that that's going to allow us to bring our different lenses to constructing the trial, to ultimately interpreting the result. I think we'll only grow from that. I think the era of having a bunch of medical oncologists or surgeons or radiation oncologists as the primary authors really should probably shift.

I think we need to think more globally about multidisciplinary care and what those, quote unquote, "tumor boards" should look like. And thinking beyond our own institutions, again, we're relatively privileged in terms of being at places where we all have at least weekly, if not bi-weekly multidisciplinary tumor boards. Most cancer care in the United States is happening in the community where a patient walks into, often a general surgeon's office, and that person will get surgery upfront whether they need it or not, or whether they should be getting systemic therapy or not first. And then from there, they will then be referred to a medical oncologist who may have had no input as to which procedure should have been omitted or discussed or vetted prior to meeting that person. And so, I think our greater challenge is how to bring in the global oncology community, and by global, I mean truly across the globe, across the United States, across the world. And it might be that ASCO and JCO, places like this for discussion, is an opportunity for us to connect people, connect our communities, and not having us work in silos, both at the institutions in which we currently are employed, but also at a broader level.

Dr. Fumiko Chino: Wonderful statement. Atif, anything to add to that?

Dr. Atif Khan: Yeah, I think you're pointing out an important thing, Fumiko, which is, you know, we are somewhat more fragmented since the pandemic, and we're kind of in our own spaces, and that is potentially a problem. I think in breast cancer, the different specialties are often existing in kind of a very cooperative matrix, and I think that ends up meaning that we're able to really provide high-level care to our patients. I think there are other specialties, I know, where the specialists may be existing in a somewhat more competitive matrix with each other, and I think that ends up potentially being counterproductive for patient care. So I think this is probably a thing that we need to have more conversation around and sort of thinking about how do we bring the different vantage points together in the interest of the patient and not lose that multidisciplinary care that we'd become so used to and that's provided such excellent outcomes.

I think on the research side, I don't want anyone to sort of be left with the idea that there's just one specialty that's sort of driving, you know, the design of these trials. From my own first-hand experience, both at Alliance and NRG, there's a lot of scientific review that happens, and I spent quite a bit of my energies over the past decade and a half kind of convincing medical oncologists that a certain local-regional question is warranted. And, and you know, that's part of the process. I appreciate that because they're not just experts in their field. You know, we all eat, breathe, and live breast cancer. So, you know, they have keen insight into the local-regional management as well.

Dr. Lola Fayanju: Yeah, I have to say I love the cooperative group meetings. That's kind of where the sausage gets made. And I think it is really exciting that you have people from different disciplines sitting together, proposing trials, vetting them. It feels like you're seeing the future in the present, which is really exciting. And, you know, I think what we're all striving to do.

Dr. Fumiko Chino: I love that hopeful conclusion, and I really am so grateful for both of you for this wonderful conversation today. Many thanks to both Dr. Khan, Dr. Fayanju, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. I hope you'll join us next month for Put into Practice's next episode. Until then, I encourage everyone to continue doing the work that they find meaningful for their patients, for their community, and for themselves.

Dr. Atif Khan: Thank you.

Dr. Lola Fayanju: Thanks so much.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Atif Khan: Stock and Other Ownership Interests: Novavax, Xtrava; Research Funding: Clovis Oncology, Merck KGaA, Varian Medical Systems; Patents, Royalties, Other Intellectual Property: Use patent for the drug riluzole awarded to Rutgers University with me as inventor.

Oluwadamilola Fayanju: Research Funding: Gilead Sciences

TRANSCRIPT 

Dr. Fumiko Chino: Hello and welcome to Put Into Practice, the podcast for the JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity.

On today's episode we'll be discussing prior authorization in cancer care. Prior auth has been a recent focus of healthcare policy and reform, given rising demands seen by both providers and patients. I'm excited to welcome an expert on prior authorization to the podcast today. Dr. Michael Anne Kyle is an Assistant Professor in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at UPenn. Her work focuses on defining and measuring patient administrative burden in cancer care delivery with a focus on prior authorization and how it impacts cancer care delivery, including patient wellbeing and outcomes. She holds a Ph.D. from the Harvard Business School, an MPH from the Harvard T.H. Chan School of Public Health, and a Master's in Nursing from the UPenn.

Our full disclosures are available in the transcript of this episode, and we've all already agreed to go by our first names for the podcast today.

Michael Anne, it's so great to speak with you today.

Dr. Michael Anne Kyle: It is so great to speak with you too, Fumiko. I'm really excited about this conversation and our shared interest in improving prior authorization.

Dr. Fumiko Chino: I love it that you've taken time out of your day to talk to me.

To start us off, can you tell us a little bit about yourself and your career? How did you transition from being a nurse into a health policy researcher? Did you always plan on a career in research or was there some specific event or transition that put you on this path?

Dr. Michael Anne Kyle: There was not. And so for anyone who's listening, who isn't sure what they want to do, I guess I have a good story to show that you actually don't need to know in advance. I started out as a critical care nurse and I still actually work as a critical care nurse. But as I think anyone who is a clinician who's listening to this knows, when you work in the healthcare system you just see so many things that could be different, that could be better. You notice the ways that the systems like really aren't set up for us to do our work or to take great care of our patients some of the time. And so that's really what sparked my interest in policy and in research. So I had really no background.

After working in a hospital, high acuity critical care, a lot of oncology, I spent several years working in community-based programs in New Jersey and this is before the Affordable Care Act. We were focused on access to medication, trying to get people more access to Medicaid, and did work around the initial rollout of the Affordable Care Act. And that experience where I spent a lot of time helping people enroll in social programs really gave me like some of the first insights into how much paperwork and how much time and how tedious it is to figure a lot of this out, even if you had someone helping you it's still challenging. And that sort of stayed in the back of my mind as I went to grad school. And really what got me interested in like all the non-medical side of patient care is just like my friends and my family talking to me about it. And I think it's something we all just experience in our lives, but there just wasn't a ton of research. And so I've really been motivated to try to put some, like, numbers and evidence beside all these experiences that we know very deeply.

Dr. Fumiko Chino: So what I'm hearing is that you learned yourself by doing the work, how difficult the work was to actually obtain services for your patients, and so you decided you needed to go upstream to try to address some of the policies that were fundamentally broken, causing these horrible situations for your patients.

Dr. Michael Anne Kyle: So well said. Yes.

Dr. Fumiko Chino: Now, I heard that you just moved from Boston to Philly. How's that transition going?

Dr. Michael Anne Kyle: It's great, it's great. Many of the same familiar faces and also exciting to meet new people, learn new things, try new restaurants. So yeah, overall I feel very lucky.

Dr. Fumiko Chino: Well, with that background, we need to dive into our actual topic, which is prior authorization. It's unlikely that anyone listening to this podcast has not encountered prior authorization in their practice or due to interactions with insurance for themselves or for their family members. Can you give me a quick overview about prior authorization? What it is, what it is not, how did we get here?

Dr. Michael Anne Kyle: Oh, so every healthcare system needs some sort of coverage policy. What services are we going to cover and at what cost? And there's many ways to do this. There are countries that sort of set this up nationally. Here in the US, we do not do that. We do it prescription by prescription, and that's how we end up with prior authorization. So basically, prior authorization is a request you submit to get approval for coverage for a drug or a service that you want to give your patient. And so you may need to submit, and again, I'm sure everyone listening knows this well, but it can range for something very quick like, "Yes, this person has like the genetic target for this drug. Check, they can have it," or it can be a more complex, protracted exchange. That is the sort of intellectual side of this. And I want to separate that from like the actual decision making from the other huge piece of prior authorization, which is how we operate it. And that is the bureaucracy and the fax machines and the time on hold, which has a separate bucket of problems. And so I just want to sort of carve out those two categories when I think about prior auth and what we need to do.

Dr. Fumiko Chino: One thing I always try to say is that even with prior authorization, even when it is working as functions, it is itself not a guarantee that a claim is even going to be approved. You can obtain prior authorization and then still face a denial for the actual claim, which is even more frustrating. And I think this kind of cumulative burden of suffering seems to me to be at an all-time peak. So can you give me a little bit of background about how the US healthcare system evolved to include prior authorization? Like why does this really even exist?

Dr. Michael Anne Kyle: Great question, and you'll get a different answer depending on who you ask. But overall, we need as a society to make a decision about the services that we are going to provide to one another. There's many different elements to that decision. One of the challenges in the United States is that we have little to no policy around cost. So when our healthcare can cost an unlimited amount, that makes it higher stakes and a trade-off is that there can be other restrictions on access. So we really don't have any constraints on cost in the U.S. other than administrative tools like prior authorization. And so that leads us to use it, I think, in ways it wasn't designed for, because there is a clinical use of prior authorization that's very appropriate, that we are doing complex things with patients that may or may not be a good fit, and we really want to figure out if this is the right match.

That is separate from healthcare is very expensive and unaffordable and we have no way to try and solve that problem except to try and put more restrictions in place, like making people go through a bunch of approvals and either discouraging them from going through that process or, you know, causing attrition through the process.

So I think one big element to how did we get here has to do with healthcare being very expensive and I think that dominates our minds. And I think there are other rationales for prior authorization that are very appropriate. But I think to your point, it's hard right now to see the times where it makes sense to go through this review process because so often you're experiencing prior authorization for treatments and medications where it just doesn't make any sense.

Dr. Fumiko Chino: One thing I've heard you speak before about is the Medicare Part D protected status that requires coverage for all or substantially all of drugs in the anti-cancer therapy treatment. Do you mind speaking a little bit about how that affects utilization management?

Dr. Michael Anne Kyle: Yes, great point. So one of like the most strictest restrictions you could put is exclusion - so you could just not cover a drug or a service. And we often don't think of that as a coverage restriction, but of course it is. But as you said, there are certain types of treatments and services where we have put in place policies to prevent exclusions because we thought these were important treatments and we didn't want them to be excluded from coverage. And in the Medicare program in Part D, which is the outpatient drug benefit, there are several categories of medications that are protected classes, and one of them is oncology drugs. So that means oncology drugs cannot be excluded from the Medicare Part D program unless there's a substitute. Like for example, if the drug goes generic, you could just cover the generic, but otherwise you have to cover everything. So that means that the only mechanism available to try and influence decision making and influence utilization is prior authorization. And that, I think, contributes to why we see such tremendously high rates of prior auth in oncology drugs in particular.

Dr. Fumiko Chino: So you're saying that a policy that was put in place in theory to help protect people with cancer may actually be placing disproportionate burden on them?

Dr. Michael Anne Kyle: Yes.

Dr. Fumiko Chino: Ironic.

Dr. Michael Anne Kyle: Yes.

Dr. Fumiko Chino: Virtually all patients and providers that I have talked to have felt like prior authorization has gotten worse in the last five years. Is this just a feeling or an emotion or does the data support that we're dealing with higher prior auth burdens more than ever before?

Dr. Michael Anne Kyle: Yes. So I think one reason prior authorization has come to the forefront of people's attention is because the prevalence is increasing. The reason for that seems largely to be driven by some larger changes in coverage, notably increase in managed care. So most of the Medicaid program is now in Medicaid managed care. In Medicare for older adults, Medicare Advantage is now a huge proportion of that program. So as managed care coverage becomes more prevalent, with that comes more utilization management tools. So then you face it more and more in your clinical practice and for your patients. So that's one major driver. And then the other thing is that as the cost of drugs goes up, so does the effort to contain costs.

Dr. Fumiko Chino: The downward pressure for cost management.

Dr. Michael Anne Kyle: Exactly.

Dr. Fumiko Chino: Now, you said managed care. And I just want to clarify for our audience, when you say manage Medicare or managed Medicaid, what do you mean?

Dr. Michael Anne Kyle: Thank you for reminding me to clarify. So in the sort of classic Medicaid or Medicare programs, or how insurance used to be when those programs first started in the 1960s, is, you know, you would like get your insurance card and you can just go around to anyone who takes that insurance. Managed care is just like a more active type of insurance where you'll have like a defined network - these are the doctors who are in your plan that you can go see, otherwise, you have to go out of network or these are the services that are covered, or these are the drugs that are covered. So managed care basically means the insurance company is taking a much more active role in the design of the benefit and so then that's why you'll see more utilization management.

Dr. Fumiko Chino: So instead of, for example, straight state Medicaid, which would be a state provided, federally funded plan, it's a private company who's actually providing those services through a contract through the state.

Dr. Michael Anne Kyle: Yeah.

Dr. Fumiko Chino: And similarly for Medicare Advantage plans, it's a private company who has decided to take the money from the federal government and then ends up providing your health care as someone who's over 65 who signed up for an MA plan.

Dr. Michael Anne Kyle: Yes. And there's two reasons that contracting ends up happening. One is that it's easier for budgeting purposes for the state, just kind of like issuing a contract. But the other thing is that states don't have the capacity to administer complex benefits. And so there aren't really like people to implement prior authorization or this type of complexity, like in the government itself. And so that's why we tend to see these kinds of practices more in insurance companies.

Dr. Fumiko Chino: Yeah, I was shocked. You know, one of the great wins of the, for example, Affordable Care Act was expansion of Medicaid, which seems great, you know, to provide health insurance to more people. But then along with that came the rise of the managed Medicaid programs, which is essentially, it sounds like states kind of got overwhelmed and could no longer manage their patients on Medicaid. Does that seem accurate?

Dr. Michael Anne Kyle: I think there's a couple of things. So one, this is the time period when I was still working in a lot of like, on the ground Medicaid public health work. So Medicaid expansion happens like still kind of in the aftermath of the Great Recession. So there had been tremendous layoffs in like, reductions in state capacity, while at the same time there was this huge expansion and like their scope of work. And so I think like a lot of the reason that managed care arose was that like they're just, you know, there had been these huge layoffs and there weren't people left in the Department of Health or in the Medicaid office. And so it was necessary to bring in external partners because the government had been understaffed.

Dr. Fumiko Chino: It's such a good point. I actually love this little bit of history you taught me because I'm always trying to tie the red thread to the red thread. Like this policy led to this either benefit or deficit. And I think, you know, stepping back one click further to say this was the environment in which these policies were enacted is so helpful when we put these things in context. It has like the benefit of talking with someone who's really a policy expert, that really helps me understand these things better.

Now, most of the data on prioritization has been really physician survey data. It shows that we hate it, it wastes our time, it increases staff allocation, it causes endless frustrations for us. Now, your work has mostly been focused on the burden on patients. Can you share what research has shown about this?

Dr. Michael Anne Kyle: I decided to focus on patients because there was just no evidence. And so there's not a ton, but there is some evidence about the experience of physicians, and everything you said is spot on. But my work finds that like you think that the pie is just what the physicians are dealing with or what the health system is dealing with, but actually like the pie is even bigger because there's this whole other chunk of work that patients are doing that we haven't really accounted for. Because of course you are spending your time after hours on hold, doing peer to peers, but at the same time, like letters are getting sent to the patient's house and they're trying to figure out what does this mean and they're also making phone calls, trying to understand what happened.

So I started this work with a national survey of adults 18 to 64 who are insured. This is just like people off the street, like not necessarily any particular health issues. And 1 in 4 people said they had delayed or foregone care in the past 12 months due to an administrative barrier. And one of those barriers was prior authorization that patients reported. And the structure of that question is the same as the way we ask questions about access barriers related to cost. And so the magnitude of barriers related to these administrative burdens is about the same as the barriers that people are reporting related to cost. And I think that's really important because we all have this sense that it's a hassle or a problem. I think it's only recently that we're understanding that it's not just frustrating, that it actually really does affect access. So that was like one step.

Then I have another piece of work building on that where I thought, okay, so patients are reporting that this is a problem and candidly that's sufficient because they're stressed and they don't feel well. But I looked at oral anti-cancer drugs and said, "Okay, like can we observe in data this phenomenon that patients are reporting that they're having issues with delayed and foregone care?" One of the challenges with claims data is you only see the claims that got billed. So we can't even see the people who got a prescription and never filled it. And I'm sure that you have many personal experiences of that with your patients and so do many of the people listening. But I'm not even able to see that in claims. So I just looked at people who were already taking a medication, already taking an oral anti-cancer medication. So we think, "Okay, they're consistently filling it so we know they're like on this regimen, and then their plan introduces a new prior auth policy on that drug and what happens to them?" And we find that people do experience delays in foregone care, that people with a new prior auth introduced on this drug they were taking have an average of a seven-day delay in their next fill after the prior auth, and that they have about seven times the odds of never filling that again. And this is for people, remember they're already taking this medication, which means they're connected to care, they have a doctor who's following them and there are policies saying in Medicare, and so this is in the Medicare population and there are Medicare policies which say, you know, you're supposed to just like roll people into coverage. If they already are on this medication and there's a prior auth, you're just supposed to continue and not impose a new prior auth on them. And that may be true, but in practice that policy isn't working because there's a delay of some kind.

We don't really know what's happening in that time. We just know there's a disruption. And whether it's because they have to do a prior auth anyway or they found out they didn't need a prior auth, the point is like there's an administrative barrier that's arising for people who are then not taking their imatinibs, not taking their erlotinibs, not taking their abiraterone. So like it's really concerning and that does not get us to health effects. One of the challenges in studying health effects is that the sample sizes get smaller and smaller and it's hard to attribute outcomes, especially for people with complex illnesses, to like one particular event or one particular cause. So that's something that sort of remains on my bucket list and hopefully on other researchers' bucket lists. But I think that you as a physician and the other people listening get a contextual sense that these are drugs that you really shouldn't be going off without, like a planned clinical reason.

Dr. Fumiko Chino: You know, the research that you just discussed was published last year in JCO, and I remember when I was talking to you about the study that you said something along the lines of you couldn't do an updated analysis now because this was a plan that didn't have a prior auth, that now needs a prior auth. And so you were looking at these transition points, whereas, by the end of the study period, basically every single plan had prior auths.

Dr. Michael Anne Kyle: Yes. So that study we looked at data from 2010 to 2020, I believe, or 2021. But most of these switches of like introducing new prior auths were happening in the first five years, usually before 2015, 2016. So I was trying to look at newer drugs like you said, but they're all coming onto the market with prior auth, and I can't study the new stuff because there's no variation to study. So thank you for mentioning that.

Dr. Fumiko Chino: So you can't document the harm of prior authorization because the best case scenario of no prior authorization doesn't exist.

Dr. Michael Anne Kyle: It's getting rarer and rarer for the oral cancer drugs, that's for sure.

Dr. Fumiko Chino: Now transitioning a little bit, there were many people, myself included, that were anticipating that prior authorization reform would make it into the lame duck session closing out 2024. Do you have any policy updates or insight into this?

Dr. Michael Anne Kyle: So I think the updated Improving Seniors' Timely Access to Care Act, I've been following that for a couple of years and I think the latest iteration is quite good. It really focuses on these, like, administrative improvements that I think are really an urgent priority because there's no reason that we need to be having all these hassles with paperwork in 2025. I just want to mention this bill includes actual phrasing like a facsimile does not count as electronic documentation. And I was thrilled to see that.

So what I like about this bill, and I hope it will survive and endure, is that it speaks to a bunch of priorities that I think are important. One, everything needs to be automated or everything needs to be electronic. We're still doing way too much fax, way too much paper. The bill doesn't mention whether the electronic requirement includes appeals, and it really should. If I was going to have one strong piece of feedback, it must, because I'm concerned that if we make the initial application process online, it'll just get denied and then appeals will be on paper and then we'll be back to square one. It also will really increase reporting and data access which will be helpful. One of the challenges in studying prior auth is that it's hard to get good data. Like I said, claims data, we only see things that were billed. We don't really have a great sense of payer policies. And this bill would require reporting from payers to say like what their prior authorization requirements are, denials, appeals, grievances and so on, which will be very helpful.

Although I want to highlight on this point, there's some new work on billing, which I don't think will come as a surprise to any of us that there are unfortunately inequities in the appeals process. And so this is work by Alex Hoagland and Michal Horny and colleagues and they looked at preventive services which are supposed to be covered under the Affordable Care Act. So you have some like objective sense of what the bill should look like. And they look at errors and then they look at appeals. And there are inequities by race, there are inequities by education and income in who is even appealing an erroneous bill and then how successful you are in appeal. And so while I think more transparency throughout this process is great, I remain concerned that like relying on patients and physicians to recognize and initiate appeals places disproportionate burden on our patients who can least afford it.

Dr. Fumiko Chino: I was personally very disappointed that the Improving Seniors' Timely Access to Care Act, which is the world's longest House and Senate bill title, wasn't part of the end of year spending package. I was really hoping we could pass it through the finish line, especially because it has a zero-cost dollar from the CBO, which was a major point of resistance before. And I know this is something that both our ASCO and ASTRO, our large societies for oncologists, have really been trying to rally support around consistently and it really does seem to have bipartisan support.

So outside of federal legislation that did not make it into the spending package, how do we fix this? You know, I was rereading your New England Journal of Medicine 2023 Perspectives, highlighting some potential consequences and barriers to prior authorization reform. Can you discuss this as well as whatever specific federal, state, institutional policies or even really provider level advocacy that you feel like could get us out of this mess?

Dr. Michael Anne Kyle: Sure. I still have hope for the Timely Access to Care Act because it's been kicking around for a few years and it keeps getting worked on, improved. So hopefully 2025 will be our year. The perspective that you're talking about refers to a CMS rule that at the time was open for comment but has since been passed and is scheduled to sort of go into service in 2026, 2027. And that incorporates a lot of the same elements as the Timely Access to Care Bill. So for example, it requires that these processes be electronic. Again, the question of appeals is a little bit vague, but making them electronic, requiring the reason for denials to be provided, providing paperwork to the patient and to the physician about the status of the application, and if it's denied or has a problem, why. There's a whole like IT element of this where there's a patient portal piece so that patients would also be able to log in and track the process themselves. On the one hand, I think that's nice for people who want to, you know, follow along. On the other hand, you know, if you don't feel well with cancer, ideally this should be getting addressed without you having to log in and check up on it. You could be like resting, recovering, enjoying your family. But overall, I think there's an understanding that we have to move away from this very analog process that we have now. So that I guess is going to come online starting in about 12 months. And then there's a bunch of work going on at the state level. Some states are requiring electronic PA, which I think is terrific.

Throughout these bills, there's also some time deadlines on these decisions. So I think having a turnaround time, whether it's like 72 hours or seven days, whatever it is, I think it's good to put those into place. I worry about an unintended consequence will be that if they can't meet the deadline, they would just deny it and you would go to appeals. And again, coming back to my fixation on like, what does the appeals process look like, but I think overall it would be very helpful to have some like, better definition and better clarity.

One thing I haven't seen in these, but I hope that policymakers and advocates will become interested in is I would really like to see some more standardization of these forms across payers. Obviously, the dream would be like standardization and actually like the parameters. But even if we can't get there at least like the paperwork could look the same because there's a lot of duplicated effort in filling out the forms and submitting these. This is really unnecessary, like it should all just look the same. And we keep reinventing the wheel which slows everybody down. And I think there's a huge policy opportunity there to promote standardization that if we have to do this, like at least it could be less painful.

Dr. Fumiko Chino: Absolutely. And I always try to highlight when I think about state level legislation, things like Gold Card Acts to my knowledge have not included any cancer services as part of what you could be gold carded for. At least not, again, not that I'm aware of at the various states where they have passed Gold Card legislation, which is a promising way of facilitating approvals. But so far, cancer patients are still kind of left out of that. Have there been any institutional policies that you've noticed seem like they help with prior authorization?

Dr. Michael Anne Kyle: No. And I think a lot about my research, like who my audience is and its organizational leaders and policymakers. And I would really like to see clinical organizations advocate for more standardization and more process improvement. I understand the emphasis on like we don't like prior auth and we want less, but I think there's an easier win in asking for this system to work better. And I'd love to see some of our health care organizations put their weight behind that.

Dr. Fumiko Chino: I have to say, since transitioning institutions to MD Anderson, I've actually been very pleasantly surprised within our radiation oncology department how streamlined the process is. And I think it's because we had a motivated faculty member who went deep into the prior authorization process and why the plans were being denied, got all of the constraints that would trigger an approval and basically built them into our planning process. So it's been really streamlined, but it was a lot of investment upfront to kind of get it to the point where it is now.

Well, I think we are wrapping up our time together. Do you have any last thoughts about prior authorization or have what we already said has it been disappointing enough?

Dr. Michael Anne Kyle: Well, let me finish on a positive note. I think what's exciting about this is that we've spent many decades on trying to improve the cost challenges in healthcare. We have the Affordable Care Act. I don't think we've yet put the same effort into non-financial costs. And so I think there is a lot of hard, hard stuff ahead. But I think there's also a lot of these challenges I think exist because no one has looked at them yet. Like how much prior authorization is like a strategic decision? And I ask this to everyone, how much is it of it is a strategic decision versus how much is like the manual is lying in someone's cubicle and hasn't been updated in years and if only someone with decision making authority looked at it, they would be like, "Oh, yeah, you can take prior auth off it"? You know, like, I just think that there's a huge opportunity to do better here because we haven't paid it enough attention. So I think we should be hopeful and I want to do better for our patients. Like I want to feel prouder of the healthcare system that I'm a part of.

Dr. Fumiko Chino: 100%. No, I love that. And that's a great hopeful end, which is that with data maybe we can start to work our way out of this. And so that's maybe a siren call for researchers coming online to think about galvanizing yourself to provide data as to what we can do to improve.

Well, thank you so much for such a robust conversation today about such an important topic. So many thanks to both Dr. Kyle and to our listeners for your time today.

For listeners that are interested in advocacy, I would encourage you to visit the ASCO ACT Network where you can send pre-drafted letters to your lawmakers on important legislative issues impacting cancer providers and their patients, things like prior authorization.

You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear from the JCO OP Put Into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. I hope that you'll join us next month for our next episode. Until then, keep fighting the good fight for our patients.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

Guest's Disclosures:

Dr. Michael Anne Kyle
No relationships to disclose.

TRANSCRIPT

Dr. Fumiko Chino: Hello and welcome to Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability and equity. On today's episode we'll be discussing our friend, the Electronic Medical Record and how this essential tool for documentation could be re-envisioned to be more patient centered. This discussion will be based off of a JCO OP article published in late 2024 called, "Re-Envisioning the Electronic Health Records to Optimize Patient-Centered Cancer Care, Quality, Surveillance, and Research." 

I'm excited to welcome two guests, the first author, as well as a patient researcher advocate, to the podcast today. Both are passionate about improving how we use the EMR to communicate and provide care. 

Dr. Aditi Singh is an Assistant Professor in Clinical Medicine and Hematology Oncology with a focus on thoracic malignancies, particularly neuroendocrine tumors of the lung. She also serves as the Director of Clinical Informatics for the Abramson Cancer Center at the University of Pennsylvania. Her work focuses on optimizing the EHR to enhance provider efficiency and provide high quality cancer care. She also serves on the NCCN Guidelines Committee for non-small cell lung cancer, thymic malignancies and mesothelioma. 

Liz Salmi is the Communications Inpatient Initiatives Director for OpenNotes. In this role, she helps clinicians, hospitals and the health system understand the changing nature of patient-clinician communication in an era of growing transparency. As a person living with a malignant brain tumor, she is active in research and advocacy to ensure that the patient voice and patient-centered care is prioritized. 

Our full disclosures are available in the transcript of this episode. And we've all already agreed to go by our first names for this podcast today. 

Aditi and Liz, it's so great to speak with you today. I hope you guys are both staying warm. 

Dr. Aditi Singh: Hi. I'm very happy to be here. 

Liz Salmi: Thanks for having me back. 

Dr. Fumiko Chino: Our topic today is about how we make the electronic medical record more patient-centered. To start it off, I'd love to actually ask a hopefully non-controversial question to both of you. What is patient-centered care? How do you personally define it? Are there key characteristics or is it something that it's commonly mistaken for? Or is it like the Supreme Court's definition of pornography - 'I know it when I see it'? Liz, do you want to take that first?

Liz Salmi: Sure. Yeah. So, I've been living with a malignant brain tumor or a grade 2 astrocytoma for 17 years. And when I first got into this space, I'm a person with a communications background originally, so when I would hear that term, I'm like, "Yeah, of course, patient-centered care - like what were you doing before that?" And then in the last 11 years I've been working in healthcare and the last eight years specifically with the OpenNotes team at Beth Israel Deaconess Medical Center. So, when I would hear that term, I was like, "What were they doing before that?" Like still even more frustrated. So, it to me sounds like jargon, like a bad form of jargon. And I think that there's new words we could be evolving into over the next, say, decade, maybe sooner.

Dr. Fumiko Chino What are those words, actually, just out of curiosity? 

Liz Salmi:  I want to co-design that with patients. 

Dr. Fumiko Chino: I love it. So that's still a work in progress. I love it. 

Aditi, what's your take on patient-centered care? 

Dr. Aditi Singh: I couldn't agree more. It should just be synonymous with good care. It should just be very obvious. It's a no-brainer. In 2025, it's sad to me that when I was thinking about this question, I'm thinking, "Yeah, what did we do before that? What is it called? What is the opposite of patient-centered care? Shouldn't certainly not be provider-centered or like hospital-centered care." So, I'm all for it. I'm glad that this generation of medical students, nursing students, everybody's going through learning this concept, even though it should really be something just so organic. But I'm glad that we're putting an emphasis on it, that there is no other way. This is the only way of providing good care. The more agency patients have and for them to be empowered to fully participate in understanding their care, fully participate in their care, I think that's what it means to me. 

I think sometimes I see misinterpretations of it in the sense that, well, that means that everything the patient says I have to do as a provider. And I feel like it's a partnership, it's not a restaurant where they're saying, "Okay, I want that. And I just make this up." It obviously has to be within your professional understanding. You're still trying to do the best for the patient in front of you. But within that, because we know there's so much gray area in medicine, not everything falls neatly in our evidence-based guidelines and algorithms. That's really where all the nuance is and that's where we can do a better job at taking care of people, if we work together.

Dr. Fumiko Chino: Absolutely. I think you said the key word for me, which is 'partnership', because it really is. It's not like the patient as a consumer, it's a partnership. And I think patient-centered care for me really emphasizes this concept of shared decision making. And again, yeah, it blows my mind that this is like a newer concept that we didn't really, in the paternalistic world of healthcare, the patient was just sort of an afterthought. It was the receiver of care and not the person who was living with an illness.

Liz Salmi: Just to throw in there, there's a very well-known palliative care thought leader, Dr. Ira Byock, who wrote a book called The Best Care Possible about patient-centered care, we could say that, or 'the best care possible'. And it's a bummer that 'the best care possible' was coined and really developed by a palliative care doctor. And I hope people in the oncology community will pull a page from the playbook of all of palliative care, because to me, all of oncology care should be palliative care and that's disease treatment but also pain and symptom management. So, I just got to throw that shout out to all of palliative care in this podcast. 

Dr. Fumiko Chino: 100%. I feel like there's a lot we can learn from palliative care for pretty much everything that we do in medicine, including enhanced communication.  

Aditi, do you mind giving us a quick overview of the article that your multidisciplinary team published in JCO OP last year about how to make the EMR both more patient-centered but also work better for research and surveillance? I'd also just really love to hear about how you got interested in this topic altogether.

Dr. Aditi Singh: Yeah, absolutely. So, the National Cancer Policy Forum convened this workshop in 2022. It's a two-day workshop which focused really on improving EHRs for oncology care, surveillance and research. And we had discussions and talks from various stakeholders, experts in their fields, just putting our heads together and hoping for a better way than what we have. I think there was general agreement that we are very glad for EHRs as an advancement over paper records, but I think we all kind of felt that EHRs haven't really realized their full potential in all the great care that can come through them. And we all identified certain challenges that EHRs have brought with regards to EHRs really being formulated as primarily billing scheduling tools in the 1970s, and now it's this all-encompassing system that we use to do everything. All of our interactions are through the EHR, kind of this like thing that comes in between, sometimes we feel, like us and the patient. As providers, we talk to different stakeholders like oncologists and providers, patient advocates, patients, the federal agencies, EHR vendors. So, all of us kind of coming together, researchers, quality improvement advisors, to really figure out what are the challenges and what we can do moving forward to get to a better place. And I think my own personal journey on how I got interested in EHRs and how to use them to kind of harness their power, so to speak, to provide better care and to improve provider wellness was another one. 

I trained in India. My medical training was in India, where the system is fairly traditional and paternalistic. And then moving to the US and seeing just a lot more time spent with patients and involving them in general, there's a lot more we can do. But just coming from a place where there wasn't as much of it, it was really cool seeing that. And then through my training, just watching my colleagues struggle with how much we had to interact with EHRs. I think none of us went into medical school thinking that I'm going to sit in front of a computer all day and spend less time actually talking with my patients or always have this thing in the background when I'm talking to my patients. And so, I think seeing my colleagues and myself struggle through that and hoping for a better way to just achieve that "work-life balance," or doing what you love without getting bogged down by the administrative tasks that just keep piling up. 

And then I think my own life and my own struggles with fertility, having a late miscarriage, having a traumatic birth, and then now being a parent, once you're on the other side, it changes the way you think about these things. And I think being a patient can be so lonely and so scary. Here we're talking about cancer, and you're so vulnerable in that moment. Even as a parent, I say, you know, all your medical training goes out the window when you have a loved one that's sick. You both have beautiful stories on how you've learned from your own experiences. So, I think that was truly telling, that it changes the way you see the person in front of you once you've experienced it yourself. So, I think that's how I got into this space to hopefully move forward.

Dr. Fumiko Chino: There's a quote from the paper which was, I thought, was very telling, which was that "EHR development was driven by regulatory requirements rather than a focus on the user experience." So that's either providers or patients. They're both using the EHR, correct? It was not really built for either of us on either side of the computer, basically. And so, I love the idea of how there could be steps along with each kind of stakeholder to make things a little better. 

Liz Salmi: One thing I didn't necessarily see in the paper was that patients are actually the biggest user of the EHR through the patient portal. And so that needs to be acknowledged as well. And as you said, Aditi, like the user experience of these portals, is not great for clinicians and it's terrible for patients as well. So, I think both patients and clinicians can come together to co-design the future of that user experience for sure.

Dr. Aditi Singh: 100%. 

Dr. Fumiko Chino: And that actually segues directly into my next question, which is Liz, to kind of start off by saying, congratulations, you just won this recent award from the Society for Neuro-Oncology. And I know that your day job and your personal passion is to improve communication between providers and patients with this kind of central tenet that patients should be both encouraged and supported to be fully engaged with their medical care. Do you mind just kind of briefly discussing your career arc and how this really intersected with your diagnosis and your medical care for a malignant brain tumor? I know you mentioned a little bit already. 

Liz Salmi: Sure, yeah. None of this is pre-planned. It's just all happened. I think clinicians perhaps come into medicine, maybe not all of us, but "Oh, I want to be a doctor." And then you kind of figure out your path along the way and how you become leaders. I mentioned earlier that my background originally is in digital communications. And then at age 29, I had a massive grand mal seizure and then found out I had a brain tumor. And then jumping ahead, you know what I'm doing today and I can fill in the gaps. But today I work on the OpenNotes team at Beth Israel Deaconess Medical Center, which is one of the Harvard Medical School teaching hospitals. But the OpenNotes team, we've got researchers around the country and around the world, are really focusing on how transparency and transparent communication improves care. And so, when it's some defining words, we say when a clinical note is shared with patients, they become an open note, lowercase. And then our team is OpenNotes, a proper noun. And so, for the last 12 years, and this is before me, I've just been the last eight years, but for the last 12 years, we've kind of created this new field that's focused on research around how open and transparent communications improves relationships between clinicians and patients. And we just remain motivated by evidence that shows that when healthcare professionals offer patients and families ready access to these notes, how that improves actually safety of care as well, because you can spot errors in the record or, you know, just have more open dialogue.  

And so how I got here, grand mal seizure, communications, digital design. Really just sometimes people become patient advocates quite often because maybe they had a bad experience, a terrible experience, and they want to fight the system or co-design a thing with the system. I had the opposite experience. I had great care. I just was so curious about what was going on from a neurological perspective, from a neurosurgery perspective, move along around the lines. And then things started to change when I became a patient. It was the 'do not google the information in your records' era. We're talking about the 2000s and then late 2000s.  

And then my magical change moment is when I had to change health systems and request a copy of my medical record to like the new location. They said, "What do you want from your record?" And I was like, "All of it?" I don't know what's in it because I had really never seen it before. And so, God bless Kaiser Permanente Northern California for really giving me all of the record on like a DVD. And I had to pay for that. And so, I, of course, as a curious person, just threw that DVD into my computer and started looking at a 4800-page medical record. And I was like, "Oh, my gosh. They've been talking about me this whole time." I'll try to summarize it now, but I just didn't know that notes were part of the thing. And so that ultimately launched me to the OpenNotes team, the OpenNotes journey. Finding out that researchers at other hospitals are starting to study that. And so, I was like, "How do I get involved in that movement?" And so here we are seven, eight years later for me being part of the team and they're so wonderful academic clinicians, it's all about teaching and like training the next generation. So, I've been taught and trained and now I'm involved in the co-design research. 

Dr. Fumiko Chino: You know, I think you're underselling yourself because you as a patient PI, I think you've been on the ground floor of this concept of we need to be co-designing research around the patient experience. You've won, as part of your team, multimillion dollar grants to study quality of life and even this, I feel like this most recent award and I am not trying to paraphrase the SNO Annual Meeting, but I think you had asked, "Oh, is there registration or something for patients?" And they're like, "No, this isn't for you." Advance six years later and they're giving you an award! So, I feel like you've been on the ground floor of all of this very important move towards collaborative work with patients.

Liz Salmi: Thank you for highlighting that. Yeah, I think what I've learned in this experience is if someone tells me 'No', I want to work harder to prove them wrong.

Dr. Fumiko Chino: It's that punk rock mentality.

Liz Salmi: There we go. 

Dr. Fumiko Chino: Now, there's been a lot of consternation from both institutions and providers regarding the release of test results immediately to patients via the 21st Century Cures Act. These releases may actually even come before the primary team has been able to discuss the results and their clinical context with the patient. And I know a 2023 JCO OP article showed that 75% of surveyed oncologists felt like the immediate release of clinical information had a negative effect on their practice and/or their patients. I've certainly personally seen how the immediate release seemed to have fostered some anxiety for some of my patients. And yet I truly believe, and this is a direct quote from the manuscript, "Health records fundamentally belong to patients." Liz, I'd love to hear your perspective on this because I know that you were a first author of an ASCO Education Book. The chapter was called "When Bad News Comes to the Portal: Strengthening Trust and Guiding Patients when they Receive Bad Results before their Clinicians."

Liz Salmi: Yeah, that was a fun one to work on. It's open access, I believe, so people can go find that. But in that book chapter, we cite a couple of papers, specifically one of the papers and anyone can look this up. It's in JAMA Open, so it's open access. But well, we cite our own paper or I cited our paper with wonderful people. I was like fourth author or something like that. So, it's not just me. Saying that, all of those caveats, we cite this paper called "Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal." And what we did with that study is we surveyed patients at four sites around the country and really, we learned, despite clinician reservations, about getting immediate access to these test results, 96% of patients still want immediate access to the test results. And that stayed true even among those who received non-normal test results. Could be scary. And we actually asked them, "How did this make you feel? Were you more nervous? And they said, "Yes, but we still want it immediately."  

Knowing that and knowing that we can't put the genie back in the bottle for Cure's rule and everybody has decided people should have access to their information immediately, there are benefits to people having access to the information. So, if it's a note thing, they can find errors in the record. When it comes to their test results, they can plan ahead. And I think in the oncology perspective, I believe for folks who have an active cancer diagnosis and they kind of understand their current experience like I do, I see these immediate results, I see the immediate MRI results and I'm like, "Yeah, I still know I have brain cancer. That is not surprising to me." But I think where things are kind of troublesome, is like a new diagnosis or somebody sees something through their primary care, general care setting and then something, probably an imaging result says something worrisome and then the patient is going to Google or use ChatGPT to kind of understand their situation. And I think that this is a situation where, and this was also mentioned in the ASCO book chapter where Daniel McFarland coined the phrase, 'truth jumping'. What do we do if people have access to all the information, they feel unsupported in their care. And I think that there's a way to mitigate that, especially in like primary care settings where the ordering clinician of that test, whatever that test is, can really create some anticipatory guidance around it and say something very simple when they're ordering the test and I'm pulling a quote directly from a book chapter and other things, but it's like, "I am ordering a test. You might see the result before me. You have a choice, patient. You can look immediately or wait to hear from us. And what questions do you have?" So really laying, "Here's what's happening. Now, I'm ordering the test." And so, it creates context around. 

Dr. Fumiko Chino: Aditi, do you have any additional thoughts about this? About, for example, how to release test results effectively? How could it potentially help or harm their relationship with their oncologist? 

Dr. Aditi Singh: Yeah. Before the 21st Century Cures Act, we all had the same reservations that, "Oh, my gosh, having cancer is hard enough! Hearing it through the portal and not through trained physicians or providers who know how to break that news with some empathy and context on immediately following it up with what's next is going to be so jarring for patients. It's going to create so much anxiety." And I kind of still believe that. Yes, I've seen people who've gotten their results and it has created anxiety and it has been stressful. But at the same time, I think that's their choice. They get to decide that. We're all adults here. Obviously, it's different when you're making a decision for someone else. But we're taking care of adult patients who get to choose. And now you can give, just as Liz said, actually setting expectations as the ordering clinician and saying, "I'm going to order this," and, again, as an oncologist, most patients, like Liz said, it's really about, "Is my disease progressing? Is it back?" And patients have understood that they can read that if your impression says, 'no concerns for cancer', you kind of get that - they are like, "Okay. I'm good." Or if there's something concerning, you understand that, and it's not mind blowing. You kind of know, well, there was a percentage of chance that this would be good or bad. I think setting expectations, especially when we think it might be a new diagnosis, that this could be something that is as bad as cancer. If you are getting a colonoscopy, a screening colonoscopy, and we find something there, and the pathology is looking for abnormal cells or cancer cells, you can opt out and say, "I don't want to look at this," or you can. The other thing I encourage patients to do is just kind of see when their next appointment is scheduled because, I for one, as a patient would hate that I see something online and now I'm not seeing my provider for the next two or three weeks. So, giving enough time, a reasonable amount of time for the test to be read so that I am prepared, so I have had a chance to look at it for the patient so we can have the best discussion. 

But at the same time, once the patients understand that, and I think many patients do now, and I have both types of patients, some people say, "I don't look at it until you tell me." And there's people who look at it and then there is a lot of sometimes back and forth and we try to set these expectations that if this is something bad, if it's something really bad, where I need you to come to the emergency room right now, you're going to be hearing from me. But at the same time, it's nice that patients have that agency where they can say, "Hey, I just want to make sure I didn't get missed because I know you get a lot of test results and I hope you saw this, but this doesn't look good." You're empowering patients again to fully participate. And if you are someone who finds it helpful to ChatGPT or Google, from reliable sources- that's another thing, as a provider, I can give them reliable resources like, "Hey, this is a good website. This one, not so much. You can look at it and then you can come prepared for your visit and say these are the things I looked up. I have some questions now that I can better participate in this conversation."  

So, I think in general I firmly believe that the patient health record really does belong to the patients. They get to decide how and when they want to look at these things. But just as providers, we can help them set appropriate expectations and boundaries. And we sometimes get a lot of back-and-forth messages and we have to say, "Hey. This is non-urgent. I promise I'm going to talk about this at our visit. But just to provide good care to all my patients, I can't be in a back-and-forth kind of text message about this result." 

And then the other thing is that we can now use cool new technologies like natural language processing and these large language models where we're looking at- one of the things we get a lot is, "Oh, my God. My esophagus has collapsed." Because that's the normal way for the esophagus to be in the body unless you're eating. So, it would be nice if maybe we could have cool technologies where someone can hover over their test result and kind of translate this to me in something that a layperson can understand who's not in medicine. That includes that your esophagus is collapsed, which is its natural state. Nothing to worry about. So, some of these things we can do better with just technology.  

And I think one other thing I'll say is the onus of all of this can't only be on the provider. I think we need to make sure that the providers are supported to do the right thing because it is the right thing to provide patient-centered care and give patients the answers they want and help them through their journey of whatever diagnosis they have. So, if you have competing interests where there's profit-based companies telling you, "You need to fit in more patients and you need to see 30 patients a day and you need to make sure you bill appropriately." Because none of us are thinking that way. We went into medical school to help people and interact with people. But if you don't give providers the time, they need to have these discussions, the support for some of these questions to be handled by their staff and it can be a triage nurse who can then immediately call the patient and say, "Hey. Don't worry. Dr. Singh looked at this report and she said that this part is totally fine. She's going to talk to you more about it," but you have to have a whole team that helps the provider do that for them. 

Dr. Fumiko Chino: One thing I think that struck me about your article was this idea that by providing more support to providers, so by making the electronic medical record system work better for providers, you are actually making it more patient centered. You are basically loosening up that chokehold that sometimes the EMR has on providers to actually give us more time to have those difficult conversations or to make those phone calls and not just to be constantly documenting. 

Now, Liz, I recently read one of your many research articles that you're a co-author on. This one was in a Medical Informatics Journal from 2021 and it showed that after OpenNotes implementation, oncologist notes overall seem to become a little longer and easier to read. Yet some consistent feedback I hear from patients remains that the use of abbreviations and medical jargon stymie their understanding of their notes and their results. Do you have any thoughts on concrete steps that we can do to improve the use of the EMR as a tool to provide patient-centered care?

Liz Salmi: Yeah, for sure. How do we make these portals more friendly? I mean, they're not friendly for the docs and clinicians and they're not friendly for the patients. I mentioned earlier, the biggest user of the EHR through their patient portals is patients, and so these portals have not been designed well at all. Things we can do to make that portal easier for the patient user, knowing that now we have access to this information, we're seeing our test results before our clinicians and then we're going to message our clinicians and ask them questions. Some health systems are actually implementing penalties on patients. Like they're going to get charged for these patient messages and that's still up in the air. But with that in mind and all of that context and the amount of information that's available, some concrete next steps are to get people on the portal before something bad happens. So the proactive thing, people are used to using these tools and then from there you kind of learn the rules of the road or like what's okay or not okay or you kind of learn a bit about, "I know this question could be better asked in the clinic as opposed to through the portal because I've been dinged in some way." And it's unfortunate to get dinged in some way through those portal things. Or it's like if you keep asking me more questions, this becomes some sort of a digital visit and you might get charged for this. So, like figuring out that murky space, I feel like I'm talking about in a horrible way, but that still is like a place where getting things figured out. 

And then the thing is like the things that people like to use, things like social media are sticky and are pretty well designed. The patient portals have not been well designed. Can we pull a page from the playbook of digital tools that are working well that people like? And so that's like another ripe opportunity for co-design. And the people who build the patient portal tools, the people, the EHR vendors, I go to their conferences from time to time. Sometimes I have an abstract that gets submitted and then I get to learn what those vendors are doing and they don't partner with patients in the co-design of those things. I'm just talking about they in general but you can kind of guess who I'm talking about. But they are early phases of you know when I am at the conference and I'm the person who stands up and asks the room, "Did you involve patients in the co-design of your tool?" And they're like, "We're figuring that out." And so, it's sad that that hasn't happened. So, we could say it's sad for the clinician side but definitely sad from a patient user side especially if like that some of the systemic issues from a clinician strife perspective is, "Ah, my patients are over messaging me." 

And then another thing is we could bake in, we should be doing studies of how people are, especially people with cancers and kind of scarier conditions that make you message more, bake in things about studying what kind of maybe AI related tools to help us when we're in those kinds of scary situations. So, you know, shout out to our team as we are kind of focusing on some studies on that right now. But of course, the study is in progress and I would love to tell you the results right now and then I can't. So, it's like how do you kind of give really from a dissemination perspective how do you kind of say, "We're in progress, this is what we're learning so far." And so, from the 'what can we do right now' perspective as all of these things are going on, the Cares Act has happened, patients can see their test results. But something that has been well studied at least in the OpenNotes universe is we know from 12 years of research and 12 years of studies on the concept of when patients read their notes, they better understand their care and are more likely to follow up with what their doctor said, there's a whole body of work there. And the big tips are to patients and things you could communicate to patients are after the visit's over, reread your note. That is the concrete conversation. That's everything we talked about today. Read it. Encouraging reading your notes after a visit. And then another tip from Liz, super patient advocate, is before your next visit, read that last visit again. It may have been three months, it may have been six months, it could have been a year. Read that before your next visit. Because I know hopefully the clinician is doing that like 10 minutes before the visit. But it's like I'm going to read that and go, "Oh, this is what they said. I totally forgot that. I actually didn't do that or I did and it hasn't been fixed." So, the idea of reading the note and then reading it again later because that's what the clinician is doing as well. So, it really kind of puts us all on the same page. 

Dr. Fumiko Chino: I love it. Aditi, I'd love your perspective on this as well. As a provider, as a researcher, I think fundamentally we often don't think of notes as being education tools for patients and we need to balance this patient-centered care with other advances. Even in your paper, we're trying to get advances in quality surveillance and research. But again, there's this concept that maybe those advances in those things can be very patient centered as well. Where do we go next for this?

Dr. Aditi Singh: Yeah, the culture shift. Because I know a lot of people have said, well, these notes traditionally were not really patient facing. So, we would write a lot of things and sometimes we would take it just too far where sometimes, like I can't understand what my colleague in ophthalmology is saying. I've tried to interpret sometimes hearing tests and I was just like, "Wow, I don't know your abbreviations. Mine are different from yours." And so, I think it's a good thing that we're in general saying that these notes should be more readable because for everybody, even within the medical community, I think there's been an issue with note bloat. And some of our notes, especially oncology notes, and there's been research on this, are just some of the longest, not necessarily the best quality, notes, but just very long where it's just really hard. When our patients get admitted to the hospital, sometimes a hospital team has a hard time understanding what was going on outpatient. Your note goes on for 30 pages and I can't find out what I need to find out. And same thing for patients. So, I think, in general, it's a good thing to just push increased readability and just teaching medical students and us, as hard as it is to change. But it's a good reminder for me and say, "Hey, I wrote this. Does this make sense to someone who doesn't practice oncology?" And if it doesn't, how else could I say it where it doesn't necessarily take me an extra hour finishing my note, but it's still succinct. It's not going to have all the education that patient needs. I'm still going to have supplementary material that is very specifically patient facing because it will have more information. And then I still have my people resources, my human resources that are going to do a, say, chemo teach visit for someone who's starting a new therapy. And I have my pharmacist who's going to do that, too. But how do we use all of that so that the patient in front of me feels as prepared as they possibly can to get this treatment, go through the scanxiety that comes with scans and go through this journey feeling that they have some sort of– We're all looking for that sense of control where we have none in some of these situations. So just helping each other out this way.  

So, I think, yes, absolutely, need to make our notes more readable. We can do some of it ourselves, some of it our technology does. So, we have an autocorrect in our EHR that I use heavily and I still sometimes will write in shorthand and it just auto corrects all the words that I'm used to writing in and it just fixes all of that for me. So, use the technology. And some things we're learning too, and we talked about this in our article too, how certain things we said were using stigmatizing language, sometimes inadvertently, and how some of these biases get perpetuated. And we've just been saying that and now someone said it in a different note that got copied and pasted and now we've just perpetuated this thing that was completely inaccurate about the patient. So absolutely, more power to patients to read that and say, "Uh-uh, that is actually not what I said. And actually, can we have a meaningful conversation on what this meant?" So I do think we can do better as a community and I think if we and the EHR vendor, if they continue to use these newer technology, a lot of us are testing ambient listening and I think that'll be really cool because if I can just sit and look at my patient and not have to type anything, and I have this AI tool that kind of summarizes our interaction and makes sure that we put in all the important information in that patient's note. And then it's a great reference, like Liz said, for the patient and for me when I look at that note next time.  

Because there's also research that's shown what the patient says and what you actually type is often you just filter out so many of the things because I'm in my medicine brain, you're filtering out as people are speaking because you're also trained to recognize the worst-case things and, "Not dangerous, not dangerous, not dangerous. Okay, I'm going to write the one that sounds- chest pain. I'll write down funny tingling in your toe that happens like once every once in a while." I keep on going because I need to also focus on things that I think I can triage in my head. But this is cool. This way we get to hear the whole story and I think have more open-ended discussions as opposed to these short, "Do you have chest pain or not? Constipation, yes, or no?" But actually saying, "Hey, Liz. What's your story? Very different question. 

Dr. Fumiko Chino: And I think that just to kind of point to this concept of the patient reported outcome and the tingling in the toe that does happen every now and then but has consistently happened for the last 10 years. I feel like PROs can really potentially actually capture that better. 

I would just like to give a little last time at the end in case there's anything that we didn't touch upon that you feel like is really relevant or pressing before we say goodbye. 

Liz, anything that we missed?

Liz Salmi: Not a miss, but just a quick thing is a little bit about LLMs or AI tools in the exam room. And I just want my doctors to know that I'm also using those tools. And it'll be an interesting next few years as the patients are users and the clinicians are users and I don't want them to just talk to each other. So how do we design this stuff together?

Dr. Fumiko Chino: Sometimes I feel like patients and providers are just on the world's longest blind date. We're just trying to find enough about each other to have a meaningful relationship.

Liz Salmi: That's cute. I love that. 

Dr. Fumiko Chino: Aditi, any last thoughts from you? 

Dr. Aditi Singh: I love this quote by Ram Dass where he says, "We're all just walking each other home." We're a team. That's how I think most of us oncologists think. I love my patients. I want to do what's best for them. I think most of us are that way and I wish for our regulators, our payers, our healthcare systems, to all get on the same page so that- we want more of this. We want more of this interaction, that mutual respect and trust that is just invaluable. And we want all of those other stakeholders to come together and help support this. And I think that support's the biggest mission here.

Dr. Fumiko Chino: I love that. What a great way of ending this conversation. Thank you so much for this wonderful conversation. Many thanks to both Dr. Singh and Ms. Salmi, as well as our listeners for your time today. You will find the links to the papers that we discussed in the transcript of this episode. If you value the insights that you hear on the JCO OP Put into Practice Podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. And I hope that you'll join us next month for Put into Practice's next episode. Until then, stay safe.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.

TRANSCRIPT

The disclosures for guests on this podcast can be found in the show notes.

Dr. Fumiko Chino: Hello and welcome to the inaugural episode of Put into Practice, the podcast for JCO Oncology Practice. I'm Dr. Fumiko Chino, an Assistant Professor in Radiation Oncology at MD Anderson Cancer Center with a research focus on access, affordability, and equity. 

In today's episode, we'll be highlighting the special issue of JCO OP focused on financial toxicity. I'm delighted to serve as an editor for this special issue, and I'm overjoyed to welcome two guests who were instrumental in creating the issue. The first is my co-editor, Dr. Ryan Nipp. He's a Medical Oncologist focused on GI cancers at the University of Oklahoma Stephenson Cancer Center, where he also does cancer outcomes research. I'm also pleased to welcome Dr. Kelly Shanahan, who is an author of a narrative piece for this issue. Dr. Shanahan was a practicing OB/GYN in Lake Tahoe, California when she was diagnosed with stage 2B breast cancer in 2008. She has now been living with metastatic breast cancer since 2013 and serves as a patient advocate and research advisor. 

Our full disclosures are available in the transcript for this episode and we're all already agreed to call ourselves by our first names for the podcast today. 

Kelly and Ryan, so great to speak with you today.

Dr. Kelly Shanahan: Likewise, Fumiko. 

Dr. Ryan Nipp: Thank you so much.

Dr. Fumiko Chino: To start us off, I'd love to just set the scene about financial toxicity, our topic. Ryan, do you mind sharing an overview of financial toxicity, what it is, what it isn't, and how you got involved in this type of research?

Dr. Ryan Nipp: Absolutely. Thank you. So I always start with the idea that the NCI website, I remember when this came out a few years ago, they provide some helpful information on this topic. The definition that they provide I think works nicely. It states that financial toxicity describes the issues patients may have related to the cost of medical care. The high cost of medical care, in addition to the cost for missed work, loss of employment and travel and lodging for care, can cause financial problems and may lead to debt and bankruptcy. Financial toxicity can also affect a patient's quality of life and access to medical care. For example, a patient may not take a prescription medicine or may avoid going to the doctor to save money. Research also suggests that patients with cancer are at risk for experiencing financial toxicity potentially greater than people without cancer or other medical issues. Financial toxicity is also sometimes called financial burden, financial hardship, financial distress, financial stress, economic burden, and economic hardship. So it goes by a lot of different names. 

Throughout my career and my research to date, I developed an interest in financial toxicity as I'm particularly interested in improving care delivery and outcomes for patients impacted by cancer and this continually became an issue as I was growing and training in oncology, noticing that the financial toll of having a cancer diagnosis can be remarkably problematic and concerning for our patients. Thus, I wanted to find ways to study this issue and ultimately develop strategies to address the problem. 

So just to give a little bit of background on the current JCO OP special issue, we wanted to do this special issue for numerous reasons. We're fortunate to work at JCO OP or work with JCO OP, JCO Oncology Practice which has a unique interest in this topic. We've been working to address this issue of financial toxicity throughout our careers, I say me and Fumiko, and we felt that the current time represented a unique opportunity to take a look back and see what progress has been made, also, what problems are persisting. We are extremely proud of this special series as we've had numerous unique viewpoints captured and I think this series provides a relatively comprehensive overview of the current state of the science in this field related to financial toxicity and oncology. 

And looking back over our notes over the past couple of years, while we were planning this issue back in the summer of 2023, we had wanted to have a broad array of articles specifically focusing on the state of the science of financial toxicity, understanding the health insurance landscape, health policy issues related to this, cost of care discussions, social determinants of health, financial assistance programs, and financial navigations. We also wanted some unique perspectives on financial toxicity with regards to geriatric oncology, a global and international perspective, and we wanted to have as many articles as we can relate to the patient perspectives on this topic, which we've got very fortunate for. Specifically we wanted one to give an overview of the foundational work in this field. Number two, highlight knowledge gaps that still exist. And number three, compel the field forward to encourage interventions and innovations necessary to move oncology into a more equitable and affordable space. We are blessed to have so many phenomenal colleagues that were willing and able to share their experiences, expertise and insights for this special issue. So thank you. It was a long winded answer, but I'll stop there.

Dr. Fumiko Chino: I Love it. I 100% agree with you. I feel so blessed to have worked on this issue and it really is sort of where we are now, how did we get here, and what the future should hold, how can we be doing better for financial toxicity.  

Now, Kelly, your piece "Debt or Dying?" was a real highlight of the issue for me. Do you mind speaking on the lived experience of financial toxicity and how costs have really unfortunately driven some of your treatment decisions and your options? 

Dr. Kelly Shanahan: Yeah, thank you Fumiko. Thank you, number one, for inviting me to contribute to this issue and for your kind words about my piece. I come from a place of privilege. I was a physician when I was diagnosed, but both with early stage and metastatic cancer. Yet I still suffered significant financial impacts. When I was early stage, I had the option, obviously, of either a lumpectomy with subsequent radiation therapy or a mastectomy. Well, I live at Lake Tahoe where we have zero oncology services at my end of the lake. And so for me to have a lumpectomy, I would have to drive 45 minutes to an hour each way, five days a week for radiation therapy, for, at that time, five to seven weeks. We didn't have accelerated courses of radiation back in 2008. I had a then nine-year-old and I was in solo private practice. So if I had chosen radiation therapy, that would have been time away from my practice, loss of income, having to make sure my husband or somebody else could pick up my daughter. So I chose to have a mastectomy and that was my primary reason for choosing that type of surgery. 

Then five years later when I was diagnosed with metastatic breast cancer, again, no oncology services in my town, except for someone I was ironically subletting my office to one day a week who recommended combination IV chemo, hoping to get me closer to the starting line so I could perhaps live longer. My daughter at that time was in 10th grade, a sophomore in high school, and I would have done absolutely anything to try to make it to her high school graduation. So I did the chemo which included a taxane, which left me with permanent chemotherapy induced peripheral neuropathy. 

Now, it's a little challenging to be an OB/GYN with numb fingers because I know I wouldn't want somebody trying to catch my baby or wielding a very sharp scalpel over my anesthetized body who had trouble feeling their fingers. So I had to stop practicing medicine, which was a huge, huge impact. I will remain eternally grateful to the men I started in practice with way back in 1991 when I finished residency for insisting that I get a disability policy because that is the only reason that my family did not have to declare bankruptcy was the fact that I had a long term disability policy. But it still made a lot of impacts on things we chose to do. I remember I was diagnosed prior to the advent of CDK4/6 inhibitors and I was diagnosed early stage, prior to the advent of the Affordable Care Act, which was a whole other thing. But I remember thinking, "Oh, my gosh. If I have to go on a CDK4/6 inhibitor that's going to cost $15,000 a month, I'm going to have to pay a 20% co-pay." And that's a choice between putting that towards my daughter's college education. I would have chosen not to take that medication. Those are huge things, and that seems cheap. 

Now, I am currently on a medication that was approved a year ago that is $28,000 a month. Fortunately, I have Medicare due to disability. I'm still not quite old enough for Medicare, that covers my expenses. I met that $3,400 medication deductible within the first month of being on that medication. But that has eased the financial burden. I also chose to participate in a clinical trial last year when my cancer progressed. And I live in a ski resort town 200 miles away from a major academic medical center. So it was 200 miles each way to participate in this clinical trial. And again, I had the wherewithal to be able to put a hotel or an Airbnb on my credit card, to pay for the gas and then wait for reimbursement. Not everybody can do that. We wonder why we can't accrue to clinical trials. We wonder why we don't have the diversity that we want. Well, these sorts of financial issues are part of the reason.

Dr. Fumiko Chino: Thank you so much for that overview of what you've had to deal with during the course of your disease treatment and that realization that, 'oh, this is with privilege' that I know what struck a chord with me as a cancer caregiver. 

I was brought into the field of financial toxicity as being the primary caregiver of my husband. He was diagnosed with cancer, again before the Affordable Care Act, and we had these caps on his health insurance payouts. And so we ran up against his lifetime payout cap and essentially had to pay everything out of pocket after that. And even just for people with long disease courses or who were treated before the Affordable Care Act, they've seen a huge sea change in terms of financial toxicity. But sadly, the Affordable Care Act hasn't made actual cancer care necessarily more affordable as we continue to produce more effective treatments, but they come at these great expenses. And I think we are now at, I would say a liminal point where we're at accelerating drug discovery and also accelerating costs. 

One of the reviews in this special issue focuses on the social and legal needs. Things like housing or food insecurity, transportation barriers, unemployment and psychosocial needs. They have a bidirectional impact on financial toxicity. And Dr. Hussaini and his team really put together a nice overview on this topic for the issue. Kelly, I know you've already spoken a little bit about this, about the transportation barriers, about the difficulties being unemployed. Again, coming from that position of privilege, can you talk about how hard it's been to even just navigate the healthcare system even with your incredible knowledge base as a physician expanding on what was hard for you, if it might have been harder for other people within the larger community of people with metastatic disease?

Dr. Kelly Shanahan: Yeah, I mean, I'm a physician and I know the healthcare system and I had a hard time figuring things out. And some of this, I realize now, when I was a practicing physician, I didn't know what things cost because what things cost depends on what your insurance is. And that's true of the cost of an office visit, of a procedure and of medications. That was challenging as a patient knowing who to call to find out to get a patient assistance program. And then when you have Medicare, again, whether it's because of age or because of disability, you hear all these things about, "Call company X if you need financial support for our great drug," but that's not accessible if you have a federally funded insurance. So I think that was really challenging to figure that out. 

Fortunately, a great clinical pharmacist at UCSF really helped me with that process. And I think that's something that we don't realize as patients is there are other resources. Our doctors don't know all the nuances of the financial aspects. If you are being treated at a larger academic medical center, there should be a financial navigator. But considering the fact that most people with cancer are treated in the community, and especially if you're treated in a private practice versus one that might be affiliated, let's say with a community hospital, they may not have an oncology social worker, they may not have a navigator. And I really wish there were more programs available like the one at Levine Cancer Institute that has a financial navigation program, a multidisciplinary program to help patients. There are a lot of resources available to patients.  

I am on the board of directors of METAvivor. Our primary focus is raising money for metastatic focused research. We fund research, but we also offer resources that we can connect people with on our website, connect them to places where patients can get financial help. There is a fabulous organization, the Lazarex Foundation, which used to provide financial support to help people do a clinical trial, support for housing, support for transportation. And I know their funds are limited and that has sort of gone by the wayside, and that's really unfortunate because we want more people to participate in trials.  

And I think we have to move away from this, "Oh, yeah. We, the pharmaceutical industry, the sponsor of the clinical trial. We'll reimburse you."  Number one, they do not tell you that upfront. I knew that. I know that from the relationships I have with some people in the FDA. I know that that is allowed. So I specifically asked about that. But most patients don't know that. And I think any patients that might listen to this, if you're contemplating a clinical trial, upfront say, "I know that reimbursement for my travel related expenses and trial related expenses are allowable under FDA guidance. So how are we going to do that?" 

But I also think that this needs to be not retrospective, not a reimbursement, but for a lot of people it needs to be an upfront payment. Even things like to cover the Uber for them to get from where they live on one side of a major city to the cancer center on the other side. So we need to do that. And recently, at the San Antonio Breast Cancer Symposium, in a session for advocates with the FDA, I asked that question: Does the FDA preclude payments before the fact? Do you consider that inducement? And the answer was "No". There's no rule that says you can't do that. So again, we as patients need to be educated that there are resources available to us and don't take 'no' for an answer.  

Dr. Fumiko Chino: I love all that information. And I know certainly when I was a caregiver, when my husband was sick, we had evaluated all the clinical trial options and found one that was potentially an option for him in California. But the travel expenses were too great for us to overcome the upfront cost because at that time he was out of work, I was out of work, we were both out of work, we had no income coming in. And so those travel expense barriers were one of the main reasons why it was a non-starter to even think about the clinical trial enrollment for him. It's just depressing to think that that could have made a difference. But I know that clinical trials work. That's how we discover new treatments.

Dr. Kelly Shanahan: Yeah, and the more people that participate and the more diverse a population– If the only people doing clinical trials are old white women, then how do we know it's going to work for young black women and men or other ethnic groups? We need diversity so that we know how the drugs work, what side effects they have in diverse populations.

Dr. Fumiko Chino: Now, Ryan, I want to pull you into this. What have you found can be helpful to help assist patients who may be struggling with their social or legal needs or even just having difficulties making ends meet?

Dr. Ryan Nipp: Yeah, Kelly, I had worked in the past too with Lazarex Foundation and found them to be phenomenal and the opportunity to get more patients onto clinical trials was a no-brainer and such a valuable resource.  

So I think for this question, I do love this question, I think it depends as Kelly was kind of hinting at too. It depends on insurance, depends on the person, depends on the specific needs. But again in thinking about this, I think there's some growing evidence supporting things like financial navigation. Like you said Kelly, not every place has it. I'm actually very fortunate now at our cancer center in Oklahoma, we do have financial navigators and I always thought that was extremely forward thinking for them. We also have great social work assistance, knowing that that's a limited resource, but we have amazing social workers which I often sometimes get their expertise and help for this. There's some research out there showing that financial assistance with things like travel, lodging and co-pays could be beneficial for our patients. Again, trying to find those resources and is it sustainable? That is a tough question. 

We also have an article in this special series focused on financial assistance programs by Dr. Raghavan which is phenomenal. It's an editorial on this topic I would encourage people to look into when this comes out. I've also just lastly admired recent work that shows that there's an intervention that, I think, I'm not quite remembering where it was tested, but it's a financial hardship screening intervention where they were asking people about financial hardship and then over time were able to find that by just asking and then bringing in whatever resources might be available, this could address the issue of financial toxicity in that study and it was an extremely impressive compelling outcome with that kind of a model. What I think is the future is that we need to continue to see those types of models put into routine practice and how can we actually implement those in our day to day practice. But that to me was very promising when that came out in recent years.

Dr. Fumiko Chino: Absolutely. I think you're referring to Dr. Blinder's piece in JCO from last year.

Dr. Ryan Nipp: Yes.

Dr. Fumiko Chino: Dr. Blinder was one of my amazing colleagues at MSK before I transitioned down to Texas. 

Dr. Kelly Shanahan: Yeah, and Dr. Blinder is working on a new proposal. I am one of the advocates on that proposal again about the financial screening. And again, just even asking the question can make a difference. 

Dr. Ryan Nipp: Yup.

Dr. Fumiko Chino: Absolutely. I know you both kind of pointed out that there are limited resources, but this idea that it's sort of depressing that someone who might be in need will not actually get the assistance from their physician or their physician team or their cancer center, but they'll have to reach out to other patients, and I'm so glad that that information is being shared. But it seems like we could be doing better. More orderly assistance, more navigation, more direct help to patients who actually need it in the way that they need it because it's not one size fits all.  

Now, switching topics just a little bit, I had the pleasure of working with Dr. Littman, who is a resident at NYU, on a review in this issue about the role of cost conversations to decrease financial toxicity. And I know from my own prior research that only about 5% of oncologists say that they've had any training on discussing costs and that cost conversations seem to be rarely happening in clinical practice. Certainly from my own perspective as a cancer caregiver, I can say that cost conversations, despite incredible financial toxicity from my husband's treatment, were just not being had. Now, Kelly, have you ever had a discussion about cost with your treating team?

Dr. Kelly Shanahan: I have never had my treating team ever bring up costs. Now, as I mentioned before, when at one point I was contemplating going on a CDK4/6 inhibitor, I did say, "If I need to go on a CDK4/6 inhibitor now with this huge co-pay, I'm not going to do it." But I didn't get that, "Oh, here's some resources that we can have." I was sort of like, "We'll figure that out. You don't need it right now." And fortunately, I did not need it until I was able to get on an assistance program and then had Medicare. So it wasn't prohibitively expensive. Although I did fall into that catastrophic donut hole one year. That was not fun. 

But I think this is something that we patients talk about frequently. People, they're worrying about paying their bills, about paying their medical bills, do they pay their hospital bill or their doctor's bill or do they buy food? Do they pay their utility bill or do they pay the co-pay for their medication? And we should not, in the supposedly richest country in the world, be having to have these conversations. We share resources about people who have unused medications. If you have progression of your cancer and you have to switch medications, but you still have two months of a three-month supply, how can that be legally distributed to other patients? And there are organizations that can do that. We try to let people know about that. But yeah, patients frequently talk about this. It's so heartbreaking when someone has to do a GoFundMe to pay for their medical care or to pay for their funeral or the funeral of a loved one. 

Dr. Fumiko Chino: Yeah. My standing joke, which is not really a joke, it's more of a 'ha-ha sob', is that GoFundMe is actually the US's largest cancer insurance provider, which is fundamentally very depressing. And I think one of the points that you pointed out about just even just eliminating waste- so if I have a drug that I'm no longer using, how do I donate that to the next needy person? When my husband died from cancer, we had a supply of Zofran that we had paid very dearly for. He was past his pharmaceutical benefit. We were paying $35 a pill. This is when Zofran ondansetron was still on patent. And I was like, these pills are very expensive. And I turned them over, actually, to my mom who's a physician to distribute in her clinic because I wanted people to not have uncontrolled nausea. I know now, working at world leading cancer centers that there's no actual way of doing that here, but a community cancer center can do it. I think we just- trying to get more efficient all across the board is so important. 

Now, Ryan, how do you broach the topic of affordability with your patients? Do you try to preemptively discuss costs or really just wait for when there seems to be a problem with affordability?

Dr. Ryan Nipp: Yeah, I knew this was coming up. I think it's a bit of a touchy topic at times because you don't want to presume and like to bring it up. In some ways, there's this option of, at least in Oklahoma now, where people are traveling a long distance often to see us here in Oklahoma City. And so sometimes you can just start to broach the idea of like how much trouble was it to get here? Do you think you'll be able to make these trips every two weeks? That two hour drive, how's that going to be? But in general, I think I am talking more in recent years about the issue of financial toxicity. I agree with Kelly. It's rare when it does come up, but in recent years it's coming up slightly more often than maybe zero like it used to be. And I think, for one, it's because patients are bringing it up more. I think they're feeling more empowered to talk about it. It's more you're able to have that opening to bring this up to me. I would welcome the opportunity. Of course, I'm passionate about this topic. And then second, I think there's increasing awareness of the available resources. There actually are things that are being studied and there may be options. Whereas in the past, perhaps we were totally just at a loss, like if our patients would bring it up, we would feel awful for them, but there wasn't a lot we could offer. And again, in Oklahoma now, we have phenomenal social work that is available to us at all times, as well as that financial navigation as I was hinting at before. 

But also, Kelly, you mentioned this before and thinking about this, the fact that we have clinical pharmacists in clinic with us that are just sitting right next to us in clinic has been a priceless resource for me. I found their insights and expertise to be very helpful in finding ways to address financial toxicity. Are there other ways that we can help this person? They brought up that this new anticoagulation pill that they're getting is super expensive. What can we do to help them? Things like that. They're with me. They're willing to look into are there other things that we could be doing again? Also at University of Oklahoma, when I got here, actually, they were already doing some work on this idea of financial toxicity screening, meaning: Can we preemptively be asking patients about their financial hardship or financial needs? And then when things are identified, again, we have cancer center navigators who are available to us for those positive screens to help put people on whatever paths we have available to address those things.

Again, in our special series that we have coming out in JCO Oncology Practice, we have a few articles that also talk about this idea of utilizing screening tools and questionnaires to identify patients who may be at risk for financial toxicity. And then some of the work that's growing with regards to once you identify somebody who screened positive, what to do with that positive financial toxicity screen.

Dr. Kelly Shanahan: And you know, you bring up that idea of bias and stigma, and I think that can be easily eliminated by asking every single patient. Doesn't matter whether somebody rides the bus in or they roll up in a Rolls Royce. If we ask every single person: Are you having any financial hardships related to your cancer treatments? Then we normalize it, we remove that stigma, and then we can help more people.

Dr. Fumiko Chino: And I've definitely seen that, I'm sure, from your own practice as an OB/GYN, like STI screening, we ask every single person about STI screening and it's not targeted towards youth. We ask everyone in a cancer center for falls. Have you had a fall? That's just part of our routine screening. So I feel like integrating one or two questions about financial toxicity could be a real avenue for helping identify financial toxicity earlier. Hopefully, intervening before it gets to the point at which it's end stage of financial toxicity, so to speak, when people are not showing up for their appointments anymore at all. 

Now, we're heading towards the final part of our conversation today. I just wanted to give a little bit of space for open topic conversation. Is there anything that you feel like we really just should address for the future of financial toxicity? Whose voices are here, whose aren't? How do we make actual meaningful change to stop describing the problem but actually start to fix the problem? 

Dr. Kelly Shanahan: Well, I certainly think the payers need to be pulled into the mix because they're the ones that are leading to denials. They are the ones that are requiring prior authorization for antiemetics for highly emetogenic chemotherapy. So I think they need to be pulled into the mix. I think our physicians, our care team, need to be pulled into the mix as well as the patients and caregivers.

Dr. Fumiko Chino: Ryan, anyone that you want to have more involved in this conversation, any way to expand it?

Dr. Ryan Nipp: You mentioned it there at the end, Kelly, is the caregiver. I think we haven't done a lot of work looking at that. Again, back to the research part and describing the issue, we haven't really done a lot looking at the caregiver side. The other piece that I think as we were putting together this special series was the international global perspectives that we did have a little bit of trouble trying to find. It's just different across different geographic and global areas so that's something else that should be studied more. We kind of hinted at it today, this idea of pharmacists being involved. We haven't seen a lot of work in that space. The other thing to think about is, at least in the places where I've practiced the APPs or the individuals seeing our patients a lot of the time and also empowering them to bring this up and have some tools and just bringing them into the research realm and to future intervention development. 

The last thing I'll say, because we have brought it up a few times today, but I do think a wide open area is what do we do about clinical trials and the affordability of being on a clinical trial and making that more available or able for patients to be going onto clinical trials. I think that's an interesting space to continue to research. 

Dr. Kelly Shanahan: Yeah. Step number one, every single patient with advanced cancer should be offered a clinical trial. Again, no assumption should be made. And number two, we need to make it so that everyone can afford to, time wise, money wise, to participate in clinical trials. It was a great privilege. I am so grateful that I was able to do a clinical trial and I look forward to doing others in the future.

Dr. Fumiko Chino: Absolutely. I really think that this idea of travel burden is such a huge barrier for many of our patients for getting even standard of care treatments, but much less enrolling on a clinical trial. And every piece of data that I've ever seen shows that you will actually get more enrollment and a more diverse patient population on your clinical trials if you just open the clinical trial closer to where the patients are actually living and getting their cancer treatment. So decentralized trials or trials within community practices, trials within the NCORP or the NCI's Community Cancer Center, or even again within regional centers affiliated with academic medical centers. These are always, I feel like, decreasing that travel burden. 

Dr. Kelly Shanahan: And I just thought of one really simple way to decrease financial burden on patients. Just going for tests, imaging, doctor's visits - a patient should never have to pay for parking.

Dr. Fumiko Chino: Now, you're beating a drum that I can dance to. The parking ridiculousness. It led to, honestly, I think, at this point probably my most read research topic, which was just evaluating parking costs. And it is such a stupid thing to study. The fact that parking could be a barrier to receiving optimal medical care is so frustrating, infuriating if nothing else. And yet it is so common. I saw it in my practice in New York where they just couldn't afford to travel into Manhattan for anything that had to be done on the main center. It's a ridiculous barrier.

Dr. Kelly Shanahan: $5 an hour to park at UCSF to go see your doctor, get imaging, or get labs.

Dr. Fumiko Chino: Absolutely. And the funny thing is that the travel and the parking then must be balanced with the time toxicity, which is consolidating all appointments down could at least decrease your parking costs. But then you're literally at the cancer center the entire day and then you need to buy your lunch at the cancer center or you missed out on another day of work potentially. And so really thinking about this from a very patient centered framework is so essential to just move forward. And it's one of the reasons why I've been so honored and privileged to collaborate with patient advocates like Dr. Shanahan. 

Well, I will wrap it up. I want to thank you so much for having such a robust conversation today about such an important topic. I can't really think of a better focus for our first podcast issue. I really want to thank both of our guests and also our listeners for your time today. You can find links to the papers that we discussed in the transcript of this episode. And if you value the insights you hear on the JCO OP: Put into Practice podcast, please take a moment to rate, review and subscribe wherever you get your podcasts. As a new podcast, we really do depend on you, the listeners, to spread the word that we're out there and we'll hope that you join us next month for our second episode. Until then, please stay safe and warm in 2025.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  

Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Disclosures:

Kelly Shanahan:
Consulting or Advisory Role: Pfizer, SeaGen, Sermonix Pharmaceuticals, Jaguar Health/Napo pharmaceuticals

NATHAN PENNELL: Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consulting editor for the JCO OP. I have no conflicts of interest related to this podcast. And a complete list of disclosures is available at the end of the podcast.

Today, I'd like to talk a little bit about the complexities of providing cancer care for patients who are uninsured or underinsured, which is a relatively large percentage of patients in the US.

How do patients without insurance receive cancer care? One way is through community programs, including a program called Project Access, a care coordination program connecting patients to specialty medical care at no or reduced cost, including, in some instances, oncology care.

But how does it work? Who does it help? And how impactful are this and other programs designed to obtain cancer care for low-income, uninsured, and underserved patients? With me today to discuss this topic is Dr. Jamey Hammock, a resident in internal medicine at the University of Alabama Birmingham.

We'll be discussing the paper from he and his colleagues titled, Oncologic Services Through Project Access and Other Safety Net Care Coordination Programs, which was published online July 31, 2020 in the JCO OP. Welcome, Jamey, and thank you for joining me on the podcast.

JAMEY HAMMOCK: Hey. Thank you, very excited to be here. I did want to say too that I do not have any conflicts of interest or disclosures for this particular study.

NATHAN PENNELL: Why don't we start out by talking a little bit about how big a problem it is for providing cancer care in uninsured and underinsured patients in the US.

JAMEY HAMMOCK: It's an enormous problem. If you look at previous studies, they've looked at patients who are underserved, underinsured, or even uninsured with cancer. And these patients actually typically present with later stage disease, they experience delays in treatment, and ultimately have worse overall survival compared to well-insured patients.

So just that alone tells you how big of a problem that this is. I think that when you look at cancer care for underinsured and uninsured, you have to break those things up. And you can't really talk about it without talking about the Affordable Care Act.

So let's take uninsured patients, for example. If you look at pre-Affordable Care Act and post-Affordable Care Act, there's a great study in 2017 that really broke down these two groups, pre and post. And what they found is with the Affordable Care Act, if you are uninsured across any income level and you lived in a Medicaid expansion state, the percentage of patients who were uninsured decreased from about 5% to 2 and 1/2%. So it really cut that percentage in half, which is pretty impressive.

And then if you look at low-income uninsured patients, because they broke that down in the study, the percentage actually dropped from around 10% to 3 and 1/2%. So It just shows you when you talk about absolute numbers and then those percentages, how many individuals are really affected that have a diagnosis of cancer and are uninsured. And it gives you a little bit of insight of what Medicaid expansion has done for that group.

And then I want to touch really quickly too on underinsured. So basically underinsured patients, they don't have the means to get the care that they need, even if they have insurance. That's important.

And patients with Medicaid, for example, they have insurance, but they have their own challenges. For example, there's been studies showing that they have longer wait times to see some specialists. It's harder to find a physician that takes patients with Medicaid.

Lastly, these providers are so few and far between that sometimes these patients are asked to drive very long distances to get the care they need. And you're already talking about a disadvantaged patient population who may not have the means to drive an hour away to get to their visit.

NATHAN PENNELL: That sounds very challenging situation, even for people who technically have health insurance, and still don't necessarily have what they need to access care the way it should be given.

Can you tell us a little bit about Project Access? I have to admit, I had never heard of that before I read this paper. And it was a fascinating program that something like this exists. Can you tell us a little bit about it?

JAMEY HAMMOCK: Absolutely. So Project Access, first off, they do great work. It's a nonprofit organization that really, really works hard to try to get patients who are underinsured and uninsured subspecialty care.

So I want to talk real briefly about the history first because I think it helps you understand why Project Access came to be. I think we need primary care pretty well in the US for patients who are underinsured and uninsured. We have things called community health centers, which are federal qualified health centers funded by the government.

And they really do a good job providing primary care for patients who cannot get it elsewhere. The problem is that a lot of these patients ultimately will end up meaning a subspecialist. And there does not exist a community health center for subspecialty care that's funded by the government the way that community health centers are.

One thing to address this was Medicaid expansion. Medicaid expansion was supposed to increase the amount of patients who got insurance and thus wouldn't be able to obtain the subspecialty care that they need.

But we've already talked about some of the shortcomings of Medicaid expansion, including not all states have done that, decided to expand unfortunately. And if you're an undocumented immigrant, unfortunately, you don't have access many times to government programs.

So it doesn't do anything for those populations. There's been some other strategies, Dr. Pennell, to try to address subspecialty care in these populations, things like telehealth, and which you would need the technology, things like subspecialists actually coming to community health centers, let's say, every other Friday to see a patient who needs a cardiologist or an oncologist.

But the problem with that is it's a little sporadic, it's inconsistent. And sometimes these patients can't be that flexible and come in the only day that the specialist is going to be there. And so really, here enters Project Access to say, you know what, let us negotiate-- pre-negotiate with subspecialists in the community that surround these community health centers and find subspecialists that agree to see x amount of patients a year.

And when it comes time to refer a patient to a specialist, you contact us, and the work has been done. And so they sort of broker, if you will, or negotiate between some specialists in primary care. And they do a lot of the groundwork that it takes to get these patients the subspecialty care they need to get the results of the subspecialty visit back to the primary care. They do all of that legwork. And so they really are an incredible, incredible service.

I do want to mention, they're more of a local solution. So Project Access Birmingham, for example, it serves the residents of Jefferson County. It's not meant to be a statewide solution. They're very good at serving the patients who are near, who are in the county.

And in fact, a lot of them have requirements that you be a resident of the county that they operate in. But they do a wonderful job getting these patients the subspecialty care that they need.

NATHAN PENNELL: Well, I have more questions about Project Access. But I think you're going to answer some of them when we start to talk about your paper. So why don't you just start off by talking us a little bit about, what was the purpose of the project that you did and how did you design your quality project.

JAMEY HAMMOCK: This project started out as a genuine question I had working as an intern in internal medicine. I would see patients come into our hospital who were uninsured who had a malignancy or cancer. And I would just ask, where do these patients get their care. How are they suppose to get outpatient clinic follow-up?

So that's when I learned about Project Access locally here in Birmingham. And as you just mentioned, I had a ton of questions. So I actually went and met with Project Access and just asked them all of these questions.

How do you work? How is your funding? Who do you see? What specialties do you provide, et cetera, et cetera.

And I decided I wanted to really take an in-depth study and look at our Project Access here in Birmingham. When I began doing the literature review for that, I realized that there was not much out there in terms of this Project Access model. I was told that many other ones exist across the country, but there had not been a lot done in the medical literature describing these places and the wonderful work that they do. And so at that point, I began to zoom out a little bit and look at all of the Project Access centers that exist in the country.

NATHAN PENNELL: What did you find out when you started calling and checking in with all of the different Project Access programs?

JAMEY HAMMOCK: To kind of bring things back to home, I really was particularly interested in how these Project Access centers offer oncology care because oncology care is a little bit different than other subspecialties in terms of the resources needed to provide such care. And my interest was, how do programs who are nonprofit who are trying to work with underinsured/uninsured patients provide care that require so much resources. So that was really one of my objectives is to tailor my approach to oncology care, specifically, while also describing the programs in general.

And so what I found was that out of about 30 programs that I found, roughly 2/3 offered care medical oncologists. And then out of those 2/3, about 1/2 of those programs actually offered chemotherapy.

Fortunately, everyone offered radiographic studies, such as MRI, CT, PET scan. So they could at least assist in diagnosing or helping to diagnose suspicion for a malignancy. Obviously, that doesn't include a biopsy, but could at least sort get the ball rolling, if you will.

And then the other thing I discovered is, as I mentioned previously in the podcast, there was a lot of heterogeneity between the programs. So some programs offer transportation, some programs offered interpreter services, while others did not. Some programs required small co-pays. It seemed that everything was really tailored to their respective local community and what worked best for that community.

In terms of Medicaid expansion, which was sort of another thing we were looking at with this study, what we found is about 2/3 of the states that have not expanded Medicaid have a Project Access center. And if you compare that to states that have expanded, only about one third of those have Project Access centers.

And so our study suggests that the need for pro bono care is a little higher in Medicaid non-expansion states. And I think that that's intuitive. The percentage of uninsured patients with cancer in a non-expansion state is as high as 13%, depending on what their income is. And that's compared to about 2% to 3% in a state that's expanded Medicaid. So those are drastically different numbers and drastically different needs for patients, depending on if they reside in a state that has expanded Medicaid.

NATHAN PENNELL: But it seems as though the difference between areas that had programs that offered cancer care and those that didn't probably revolve around whether they're able to find practitioners who are willing to provide those services. And it looks like you did some investigating of programs that did and did not offer cancer care. So what were the differences between those?

JAMEY HAMMOCK: The next step of my project was to interview those program coordinators of the centers who were not able to offer medical oncology care. And three common themes emerged as I talked to these program directors.

The first of those themes was cost. And I think that that's intuitive. And it did not surprise me. Medical care is expensive. Oncology care is expensive. And these programs, they're mostly nonprofit and rely on donations and such.

And so the first barrier to offering this is cost. The patient see the medical oncologist, and they prescribe chemotherapy, someone has to pay for that chemotherapy.

And a lot of Project Access centers were not prepared to do that. One in particular I spoke with, they had actually considered it. And when they ran the numbers, it would account for over half of their annual budget. So it just was not feasible.

The second barrier that emerged while I was talking to these program directors was the concept of continuity and a longitudinal commitment. So for example, if I'm a medical oncologist and I decide that I want to take part in this and donate some of my services, and I see a patient that has a new diagnosis of cancer, and we treat the cancer, what happens if they relapse or what happens in five years that they need a medical oncologist again?

And I don't think many oncologists were comfortable committing to a situation that had no clear end date. That's in contrast to a patient that has COPD and the primary care physician is referring them to a pulmonologist to get recommendations on maintenance inhalers and what might work best for this patient. That's more of a one and done visit.

The third area barrier emerged as I talked to these patients was the concept of multiple physician buy-in. And so, as you're aware, many patients that have a cancer may require care from multiple subspecialties, whether that be surgical oncology, medical oncology, radiology, diagnostic radiology, and even palliative care. And so it really is a disservice to a patient if you can offer them not the full scope of oncological care that they need. A lot of Project Access centers were not comfortable providing some of the care without providing all of the care, if that makes sense.

NATHAN PENNELL: I mean, all of those make perfect sense. I mean, although in some ways they relate partly back to the first issue, which is that things cost more if they take a long time and have to continue indefinitely over time.

So I'm curious, for the places that did offer chemotherapy, and actually even though it was a relatively small percentage, it was not trivial, chemotherapy is extremely expensive. As you mentioned, some of them looked at it and decided it was going to be something like half of their revenue for the year would be taken and providing this. How did those that covered chemo actually cover the cost of that?

JAMEY HAMMOCK: That's a great question. I had the same question. And so what we found is that most of the programs who were able to offer medical oncology and then services, and then taking the next step to offer chemotherapy, they were affiliated with very large hospital systems in the area.

So I'll give you an example. Here in Birmingham, our Project Access center works with UAB. And they're able to offer these services because UAB takes the baton, if you will, and carries the care forward, offers that chemotherapy that is needed. So it's done through large affiliated hospital systems. If that does not exist, or if that relationship is not there, then what my study has shown is that it's not feasible.

NATHAN PENNELL: Right. That makes sense. I mean, individual oncology offices that order their own chemotherapy could probably never afford to just donate that, whereas large systems have other ways to do that. And of course, the large nonprofits also have to give back to the community and may just consider that part of their community service.

What's the next step to extend this? I guess, the larger question is, it'd be great if perhaps everyone had health insurance. But until that happens, what steps can be taken to provide something like this more broadly?

JAMEY HAMMOCK: Yeah, so that is exactly what I was thinking. Medicare for all is the answer. And ultimately I think we need a centralized universal health insurance policy. But that's not the topic of this podcast.

So until then, Project Access is stepping into the gap and doing this great work. And I really wanted them to be recognized just as a organization, broadly speaking, and then on an individual basis. They are on the ground doing the hard work, making the phone calls, making the partnerships, raising the money. They're really doing incredible, incredible work for people out there who have no other options.

It's not enough. As I mentioned earlier, these are local solutions to statewide issues. If you look at Alabama, it's a non-expansion state, unfortunately. The patients in Jefferson County here where Birmingham is, they benefit from Public Access, but the patients in Shelby County might not. So it's a statewide issue for the states that don't have Medicaid expansion, and then even a small population in the states that do.

One thing that we can do is we can look at the examples that have been set by Project Access centers who have partnered with these hospitals and collaborate and say, listen, we're a Project Access center that has not had any luck. Please share with us how you were successful in providing oncology care to your patients.

My hope is that this project provides a list where collaboration can begin. And these places can learn from each other.

NATHAN PENNELL: Well, I think that this is fantastic. And I'm really happy that we're going to be able to highlight Project Access and your manuscript so more people are aware of this and hopefully can start shining lights on their own local Project Access programs.

JAMEY HAMMOCK: Right, right.

NATHAN PENNELL: Well, Jamey, thank you so much for joining me on the podcast today.

JAMEY HAMMOCK: Thank you for having me. I thoroughly enjoyed it and love talking about Project Access and access to care. And I really appreciate it.

NATHAN PENNELL: Until next time, I also want to thank our listeners for checking in on this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts, or wherever you listen.

While you're there, be sure to subscribe so you never missed an episode. JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org.

The full text of this paper is available online at ascohubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

PRESENTER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care. And is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions.

The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles, please visit us online at jco.org.

This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

NATE PENNELL: Hello, and welcome to the latest JCO Oncology Practice Podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org

My name is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic, and consultant editor for the JCOOP. I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast. Today I want to talk about a very serious topic that all of us who care for cancer patients really had at the front of our minds back in the spring of 2020. While it may already seem like a long time ago, when the COVID pandemic was at its peak in the United States, New York City was being inundated with of COVID. And for a while there was quite a bit of uncertainty about whether they might run out of personal protective equipment or ventilators. And there were very serious discussions happening about allocation of resources.

I personally remember patients asking me, even here in Ohio, if they might not be offered a ventilator if they became sick, because of their cancer diagnosis. And while this certainly never came close to happening in Ohio, I think it actually came closer than we'd like to admit in places like New York. With me today to discuss this really fascinating topic is Liz Blackler, who is the program manager for the Ethics Committee and Consult Service at Memorial Sloan Kettering Cancer Center in New York City.

We'll be discussing the upcoming manuscript from her and her colleagues titles, "COVID-19-related Ethics Consultations at a Cancer Center in New York City-- a Content Review of Ethics Consultations During the Early Stages of the Pandemic," which was published online August 27, 2020 in the JCOOP. Welcome Liz, and thank you for joining me on the podcast.

LIZ BLACKLER: Thank you so much for having me here today. I'm definitely looking forward to discussing our manuscripts with you. Just to note, I do not have any relationships or disclosures related to this study.

NATE PENNELL: Thank you. So what was it like to be really in the epicenter of the COVID pandemic back in the spring?

LIZ BLACKLER: There was a lot of uncertainty. We were all just trying to find our way, to figure it all out. Staff was just reconciling what was happening in real time in the city and the world, and then looking into our own hallways, seeing what was happening there. I would say it was both chaotic and eerily quiet. Our ethics consultation service, as with many ethics consultation services in the hospital, went virtual. So only those people who needed to be on site were there. And the rest of us were working from home.

And so I think as a staff, we were adjusting to doing our jobs remotely, and also watching and feeling the enormity of what was happening at the hospital with patients, and feeling just a little bit far away.

NATE PENNELL: So you are in charge of the ethics consult service. I think anyone who's ever been involved in a case that needs to involve the ethics consult service knows how incredibly interesting a job that must be, and complicated. Can you just, before we get into the COVID thing, explain what an inpatient ethics consult team does, and who is on that team?

LIZ BLACKLER: Sure. So ethics consultations are most frequently requested to help analyze and resolve complex value-laden concerns that arise between or among clinicians, and patients, and/or families. Anyone-- clinicians, non-clinician staff, patients, family members, health care agents, surrogate decision makers can request an ethics consultation. And depending on the situation, the consultant may facilitate communication between the stakeholders. This also involves clarifying treatment options and prognosis.

Our consultants also help opine moral reasoning and ethical principles to certain situations. And we spend quite a bit of time confirming and clarifying state and federal laws, and hospital policy, and how it relates to the specific patient at hand. In general, the ethics consultants work closely with all parties to help identify acceptable courses of action. Our clinical ethics consultation team is a standing subgroup of the ethics committee. And the group is voluntary, and is comprised of 10 MSK employees from a variety of disciplines. These consultants are additionally trained in clinical ethics. And currently we have nurses and physician assistants, nurse practitioners, social workers, and physicians representing psychiatry and critical care medicine.

So we work in a single-modeled service, meaning consultants work independently, and then reach out to other consultants for assistance as needed. So we are a busy service at baseline. And during COVID, our ethics consultations actually doubled.

NATE PENNELL: Yeah, I can see that when you start to delve into your paper, and the issues that came up. And what are the special ethical concerns that arose that might involve COVID in patients with cancer that differed from the usual things you would see patients about in the hospital?

LIZ BLACKLER: Sure, it was actually what spurred us to do a retrospective review on our ethics consultation service. We encountered two, I would think, unique issues that came up that we had not previously seen before on the ethics consultation service. Our very first COVID-19-related ethics consult focused on a patient with decisional capacity who was admitted to the floor, and wanted to be discharged against medical advice while he was waiting for his COVID-19 test to come back.

In the beginning, it was taking a couple of days to get those results back. Staff was very concerned if a patient would not adequately quarantine at home, while we are waiting for the results. In fact, he said he would not quarantine, that he would be out in the subway, and this and that. So we were called in to assist in clarifying whether respecting this patient's autonomy to leave the hospital AMA outweighed our obligation to keep the patient in isolation, and prevent him from potentially spreading the infection.

We had never encountered an issue like that before. So in that case, we were able to support the patient, and help him understand the reasoning why he needed to stay. In the early days of the pandemic, as we were just sorting out what was causing the spread of COVID, I think we would have likely leaned towards figuring out a way to keep him, as long as we could. It's always tricky in that we don't want to override someone's autonomy, unless absolutely necessary. And so there were two cases like this, where we really had to weigh the risk to the public against individual autonomy of the patient.

NATE PENNELL: Yeah, I know. It's very interesting to think about something like that. At first blush, it seems as though there would be no legal way to keep someone if they wanted to leave. But then switch it out and say, well this patient has Ebola now, and wants to go out on their own. And suddenly it jumps to the front of your mind that maybe it's not quite so simple. It also, I think, illustrates nicely what the ethics team does, which is not necessarily to come in and deliver an academic treatise on the ethical principles of who's right and who's wrong, but to help negotiate the different parties to come to an acceptable agreement.

LIZ BLACKLER: Exactly. And in a similar case, we had a family who was wanting to leave the hospital, and go to a local hotel. But at the time, the hotels were either COVID-positive hotels or COVID-negative hotels. And this family insisted on having their loved ones stay at the hotel that was a COVID negative hotel. And so the staff called a similar consult line to know whether they had an obligation to share the patient's medical status with the hotel. And in a similar mind, we did just what you said. We pulled the whole team together. We met with the patient and family, expressed our concerns, and actually helped identify an acceptable hotel that would make a concession, that was in the geographic location of where they wanted to be, that would in fact sterilize and come up with its own private entrance for this patient. So everybody was happy, right? We knew he would be safe, and the family got to have this loved one closer to home.

NATE PENNELL: I'm sure that doesn't always end up with such a good result at the end. But that sounds like a good job. So you had some fascinating consults. So most of your manuscript is describing some of the examples of the types of scenarios that you had to address. So can you take us through some of those, both just like the general themes and then maybe some specific examples?

LIZ BLACKLER: Of course. So like I said, we performed a retrospective review of all of our COVID-19 ethics-related consults that happened between mid-March and the end of April. There were 26 consults total performed on 24 unique patients. The most common ethical issue was related to code status. So these were patients. Staff members were concerned about incubating, or performing cardiopulmonary resuscitation, because of the high risk for aerosolizing procedures.

If you remember, at the beginning of the pandemic, there was a high level of anxiety about supply shortage of personal protective equipment. So staff was very concerned about whether it was ethically appropriate to provide CPR for our patients with poor prognosis, because many, if not most of our patients at that time, not only had advanced cancer, but they had concurrent COVID-19 infection. They had a poor prognosis. Because there was a lot of risks to providing the CPR and intubation with minimal benefit, and so more than half of our consults came through that were questioning that, this idea of non-beneficial treatment.

NATE PENNELL: Well, I guess it's hard not to stop, and talk about that a little bit. So you've got a patient with advanced cancer, who presumably wants to be full code, but is COVID positive. How do you even start to address something like that with the patient and the staff who are worried?

LIZ BLACKLER: As you know, many of our patients with advanced cancer and respiratory distress, it's quite hard to have conversations with them for lots of reasons. I think complicating the situation was we had a zero visitor policy at that time at the hospital. So all hospitals in the state had zero visitor policies. There was no family or caregivers or agents at bedside. We had family at home listening to the news, and they're recognizing how important something like a ventilator was for patients with COVID, as a bridge to recovery. And many family members very much wanted to give their loved one an opportunity to recover from COVID, despite something like a stage 4 lung cancer diagnosis with no [INAUDIBLE]

And so as you can imagine, on a day-to-day basis pre-COVID, we do a lot of goals of care discussion. So we spend a lot of time with patients and families trying to help them understand the limitations to treatment at the end of life, and what is ethically and morally appropriate, and what may not be the right thing to do. And so we had to apply all of those same tactics in a very expedited fashion, talking with family who were isolated and removed from the situation, who could not be at bedside with their loved one to try to help them come to terms with what was happening.

What you may not know is New York state has a law that says full code, cardiopulmonary resuscitation is the de facto intervention for all patients, unless they consent specifically to a do-not-resuscitate order. So we were obligated by law to perform cardiopulmonary resuscitation on all patients with families who wanted it. And so we spent a lot of time talking with our families to help them understand what's happening. And some of those patients did have cardiopulmonary resuscitation, and others understood the gravity of the situation, and were more amenable to do-not-resuscitate orders.

NATE PENNELL: Yeah, it must have been incredibly challenging. But any other themes that arose in terms of the consults that you received?

LIZ BLACKLER: Interestingly we had three or four consults that came through by staff that were concerned that patients were requesting a do-not-resuscitate order prematurely, that it was not standard of care for their clinical situation. What we suspected that it was the converse of what was happening. Patients and families had this altruistic response to the local and national focus on scarce resources. So saying, wow, we understand how difficult things are right now. We're OK. Please focus your resources on someone else.

NATE PENNELL: Wow.

LIZ BLACKLER: So that was--

NATE PENNELL: Yeah, I can imagine that would have been-- well hopefully, I guess, that might not have been quite as challenging. Because maybe some of that might have been a lack of understanding about the prognosis, and people who actually did have a reasonable prognosis might-- I don't know if they were convinced to change their minds, or they generally just supported their decision.

LIZ BLACKLER: We did a little of both. I think in two of the situations, we were able to help families understand the nuances of the situation, and they agreed to a trial intubation. Other families were insistent that this was not in line with their loved one's wishes, which might have been separate from the COVID-19 pandemic.

One thing we did do with the hospitals early in the pandemic, we requested, mandated if you will, that all outpatient oncologists communicate and document the goals of care conversation with their patients on admission within 24 hours. And so each patient that was admitted to the hospital had a discussion. All those who could had discussions with their outpatient primary oncologist about diagnosis, treatment options at present, and what their wishes were regarding goals of care. And that very much helped the ethics consultation service and the services in the hospital provide care that was aligned with not only treatment options, but the patient's and family's wishes.

NATE PENNELL: That's really interesting. Because many people were listening to this podcast might think, well, gosh. Shouldn't you do that anyway when someone gets admitted to the hospital with advanced cancer? But perhaps the pandemic offered an opportunity, because patients were thinking about it now, as opposed to oftentimes when they get admitted and it suddenly is a bit of a shock to be presented with the question of what they would want if they needed to be resuscitated.

LIZ BLACKLER: Agreed. I think it's a natural opportunity for us to continue to strengthen our need for and goals of care conversations for all of our patients, whether they're stage one cancers or stage four cancers. And so I think it was this natural time where everybody was talking about it. And it just felt it was-- it was just made sense for us to do. And it is something that we've been trying to continue as a hospital. These conversations are hard to have. Patients and families are not always receptive. Clinicians are not always ready to have those conversation either. And so if anything, the pandemic brought us all together, and we all recognize in the anticipation of scarce resources how can we best take care of these patients. What's first and foremost is we have to have a better understanding of what our patient's wishes and preferences are.

NATE PENNELL: One of the things that continues, at least to some extent in a lot of places, is the restrictions on visitors and caregivers in the hospital, although perhaps not as strict as it was back in the spring. How did the inability of caregivers and powers of attorney and things like that to physically be present impact your job? And I guess more broadly, how does being forced to work over a sort of video conferencing impact these conversations?

LIZ BLACKLER: Sure. I think the level of distress secondary to the limited or lack of visitors at bedside, was palpable. So the nursing staff, the clinical staff, and non-clinical staff who were in the hospital at bedside every day were very upset. It was an incredibly sad time. And that in itself led to more ethics consultations, the amount of distress. And so we as a consultation service, worked hard in our virtual platform to provide extra support to staff who were trying to manage these patients to really take care of them in a way, in a kind and compassionate way in the midst of all of this chaos.

We started something called a virtual ethics open office hours. We actually set up a virtual Zoom twice a week where my consultants would sit on the Zoom call and just field questions, general questions that were coming up from staff. Because there was a lot of anticipation of what was to come, and how the hospital was prepared, how we were prepared to take care of patients, if we were to not have enough ventilators, or if we were not have enough blood products. And so the anticipation of all of that was very extremely stressful for staff, and I think compounded by the fact that there was no support at bedside for the patients.

I would say as a consultant service, going virtual certainly had its hiccups at first. But I actually think in the long run, we were able to really support patients and caregivers in a different way. There were more families that were able to participate in some of the family meetings, if they were scattered around the tri-state area or the country even. And so once everybody was acclimated to using these platforms, staff and family alike, then there were more opportunities for families to engage and participate in these family meetings. We were able to outfit many of our rooms with video access so that the patients who were able to participate were also able to participate, to be there [INAUDIBLE]

NATE PENNELL: It sounds like you did the best with what you could. And certainly it was tough on our patients, because they didn't have anyone to be there with them. But I can see the benefits of bringing people in who otherwise might have had trouble participating. So I wanted to just briefly touch upon something that I'm not sure if everyone realized this. But in anticipation of being completely inundated and running out of ventilators and whatnot, some hospitals were putting together protocols on how they would allocate resources. And it sounds like you may have been part of putting something like that together for your hospital. I know it was never needed. But can you talk a little bit about that?

LIZ BLACKLER: Sure. I think one of our obligations as an ethics committee is we have a duty to plan, and a duty to steward resources, and a duty to be transparent about it. So early in the pandemic, the ethics committee was asked to draft allocation policy in the event that we had a scarcity of equipment, or staff, resources, blood products. I remember being sent home from the office to start writing that policy. And I actually haven't been back since. What I will say is although an incredibly difficult policy to write, it was heart-wrenching for all of the reasons that you can imagine. It felt important to at least have a framework in place just in case. And so we made a decision as an ethics committee and consultation service to model the framework after the New York State ventilator guidelines that were published in 2015.

We made some slight modifications to address our unique cancer patient population. We chose the New York State guidelines, because they were developed just a few years before with support from our state government. The guidelines were also publicly available, and we assumed had passed with public support. There are no perfect guidelines. And so for us, in many ways we were lucky to have had a blueprint, something to work with in our state. While acknowledging that without state support, we were fully aware that if the crisis standards of care were needed, they needed to be implemented statewide with consistency.

We also struggled with trying to recognize that the policies needed to take into account inequities in access and delivery of health care, with special considerations for inherent bias, based on socioeconomic, racial, ethnic, age, and others with disabilities. I think as a bioethics community, we're working to update allocation policy that acknowledges and begins to rectify such bias. And so we're able to think about that now, looking back on what's happened a few months ago. But in real time, what we had with the New York state guidelines, which I think is a good start, those guidelines are your classic guidelines that look to maximize benefit of resource in order to save as many lives as possible.

The [INAUDIBLE] is given to patients for whom resources would most likely be lifesaving. We put into place a classic triage process that was grounded in a clinical scoring system. And we also made sure to remove the triage decisions from the bedside clinician, instead relying on a triage committee that would be made up of critical care physicians, administration, ethics consultants, or committee members, and other senior staff from the hospital to help make these determinations based on this clearly spelled out criteria, knowing that there were flaws in those criteria. And so we did put together a policy. We thankfully did not have to implement that policy. But we have the policy put into place.

NATE PENNELL: And that, I think, leads us really nicely into my last question, which is really what did you learn from all of this going forward? So if this happens again, hopefully not with COVID, but another emergency or something that leads to strained resources; what take-home lessons can you take from this that will make that perhaps an easier situation the next time?

LIZ BLACKLER: Sure I'll approach it from a macro and a micro standpoint. So within the hospital, one of the things that we learned is that our clinician's preoccupation and distress when confronted with these difficult choices in the pandemic, with the anticipation of a scarce resource, was palpable. And that as an ethics consultation service, we have an obligation to put together a center-based initiative to really support staff in real time. And so going virtual quickly, setting up services for staff that are proactive instead of reactive, it has been very helpful. And so I mentioned the virtual ethics clinics or office hours as one way to reach a lot of staff quickly, and to provide support in real time.

I think the other issue I touched on briefly, and that is working within the state and the country to come up with acceptable allocation policies that acknowledge bias, that acknowledged disparities in health care, and delivery of health care, and access to health care are extremely important. So one thing that has come out of this that I'm very proud of, as a hospital we at Memorial Sloan Kettering, we reached out to all of our colleagues in the city and upstate New York, and have recently just for formed an Empire State Bioethics Consortium. So all of the chairs of the bioethics departments from around the state, we now meet on a regular Monday night phone calls, to talk about what's happened, anticipation for future, and really working on a broad range of ethical issues that affect New York State.

NATE PENNELL: Liz, thank you so much for joining me on the podcast today.

LIZ BLACKLER: Thank you so much for having me. I really appreciate it.

NATE PENNELL: I'm glad we're going to have the opportunity to highlight your manuscript, which I think is really going to be beneficial to people who hopefully will not be presented with this in the future. But if they are, it's something to get them thinking. And until next time, I want to thank our listeners for listening to the JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts, or wherever you listen.

While you're there, be sure to subscribe, so you never miss an episode. JCOOP podcasts are just one of ASCO's as many podcast programs. You can find all the recordings at podcast.asco.org. And the full text of this paper is available online at ascopubs.org, backslash journal, backslash op. And this is Dr. Nate Pennell for the JCO Oncology Practice signing off. Thanks for listening.

SPEAKER 1: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. For more original research, editorials, and review articles; please visit us online at jco.org. This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP. I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast.

Aggressive care at the end of life for cancer patients is widely recognized as poor-quality care. And by aggressive care, I don't mean aggressive supportive care or hospice, but rather inappropriate interventions, like chemotherapy or hospital and ICU admissions, near the end of life that rarely improve outcomes and often actually worsen quality of life.

Efforts are being made to educate physicians and cancer patients to try to minimize aggressive treatments near the end of life and to help as many patients as possible benefit from things like hospice benefits and appropriate end-of-life care. However, not all patients receive high-quality end-of-life care, and there may be differences in end-of-life care in various populations. For example, how do race and things like Medicaid status impact aggressive care at the end of life?

With me today to discuss this topic is Dr. Jennifer Tsui, Assistant Professor in the Division of Population Science at Rutgers Cancer Institute of New Jersey. We'll be discussing her paper "Racial Disparities in Health Care Utilization at the End of Life Among New Jersey Medicaid Beneficiaries With Advanced Cancer," currently in press for the JCO OP. Welcome, Dr. Tsui, and thank you for joining me on the podcast.

Thanks so much. Thanks for having me. I have no conflicts of interest with this study whatsoever.

Dr. Tsui, can you please tell me a little bit about what exactly constitutes high or low-quality end-of-life care?

Sure. I mean, I think that, in this study in particular, we wanted to focus on guideline-related end-of-life care. So we wanted to see if it was possible to take a look at patterns at the end of life for breast and colorectal cancer and stage cancer cases and see sort of what the patterns were in relation to adherence to guideline adherence and what they should be receiving at the end of life.

And so that included a set of measures around aggressive care related to hospitalization in the last 30 days, emergency department visits in the last 30 days of life, an ICU admission in the last 30 days of life, and chemotherapy in the last 14 days of life. These are guidelines that have been discussed and published by national organizations. And we also looked at hospice enrollment. So we looked at whether there was any hospice enrollment and whether there was hospice enrollment in the last 30 days of life, I'm sorry.

Are there already data existing for various disparities in end-of-life care among different racial groups or patients of different socioeconomic status?

There are. So there have been a few prior publications before our study that have shown that Medicaid patients frequently-- not just for end-of-life care, but cancer care in general-- that Medicaid patients receive lower quality of care. And there were studies done prior to ours that did show, I think, in New York, for example, that Medicaid patients had lower-quality end-of-life care compared to Medicaid and privately insured patients.

We have seen other studies also mentioning disparities by race in terms of quality of end-of-life care. However, I don't think-- some of these studies have focused on different populations and cancer sites. So some of the studies I mentioned looked at AYA, adolescent and young adult cancer survivors. Other studies have focused on other cancer sites.

And also, these were studies that were conducted in earlier time period. And what we know is that, given all that's happened since the Affordable Care Act and Medicaid expansion in several states, sort of the Medicaid population has changed, but sort of health care delivery has been redesigned in different ways. And so that was really why we wanted to look at this issue sort of in more recent years and during a period that spanned Medicaid expansion within New Jersey.

You know, that's helpful to understand what sort of prompted you to do this. So why don't you tell our listeners basically how you designed your study.

Sure. So this was a large data linkage that we established within the state of New Jersey to better understand cancer care quality for breast and colorectal cancer patients in general, so beyond just the stage IV cancer patients, the patient's diagnosis at stage IV, but breast and colorectal cancer patients in general.

So we worked with our New Jersey State Cancer Registry, identified all our breast and colorectal cancer cases that were diagnosed between 2011 and 2015, and then we linked those with our New Jersey Medicaid enrollment and claims files. So this was a study that was done in partnership with our Rutgers Center for State Health Policy. It was conducted sort of with ongoing input and feedback from both our State Cancer Registry as well as our Medicaid program. They've seen sort of findings related to this and other research questions we've had throughout the process.

And what we really ended up with was a very rich data set that not only gave us all the tumor characteristics that are available in the cancer registry, but also the health care utilization patterns and Medicaid enrollment characteristics that are available on the Medicaid claims and Medicaid program data side.

And how well did this database capture all of these measures of aggressive end-of-life care, so ED visits and chemotherapy and such?

Since we did focus on those who were continuously enrolled in our state Medicaid program, we were able to go through our claims data and be able to, using billing codes, identify things like ED visits, et cetera. This data set only includes cancer cases up to age 64. So we didn't include people who may be dual enrolled in Medicare or have Medicare claims.

We also tried to create some other restrictions so that we can get at just the people where we had a definitive diagnosis month and year and follow them through their death. And so we did use the prior studies that I mentioned earlier to see what kind of codes were used there.

We have quite a multidisciplinary team of collaborators. I worked with quite closely the first author here, Annie Yang. Soon-to-be Dr. Annie Yang is in medical school here at the New Jersey Medical School. And so we did try to be as comprehensive as we could with the codes we used to identify those utilization patterns.

OK, so why don't you tell us some of your findings?

So I would say that the overall finding is that 62% of these stage IV breast and colorectal cancer patients received at least one measure of aggressive end-of-life care. So out of those four individual measures, 2/3 received at least one, which seems quite high. They ranged from 27% having at least one hospitalization to 34% receiving chemotherapy within the last 14 days of life.

What we found is alarming, and it's sort of a call to action for addressing racial and ethnic disparities in health care, is that we found that our non-Hispanic Black patients had a higher odds of receiving any one of those aggressive end-of-life care measures after controlling for other factors. So we did find this racial/ethnic disparity in non-Hispanic Black patients having more aggressive end-of-life care compared to our non-Hispanic white patients, even though these are all the same Medicaid program. This is within one state.

And so it did point to some need to better understand what is going on within the health care system, within the health care encounter between patients and physicians towards the end of life and what needs to be done to address these disproportionate rates in end-of-life care among racial/ethnic minority patients.

When you talk about these numbers, like 2/3 of patients having aggressive end-of-life care and 39% enrolling in hospice, how does that compare to what would be considered a more appropriate level, say, the private insured patients?

So we didn't compare it to privately insured in our state, but we did look at what was published in other states. In New York, for example, I think we had a slightly higher proportion of Medicaid enrollees with stage IV breast and colorectal cancer having more aggressive care. So we did see higher rates. So while we can't compare within our state alone, we do see that the rates are slightly higher than other published studies.

Well, I guess I'm just trying to figure out, is aggressive end-of-life care something that commonly happens to all Americans in general, or is this vastly more in this population than what we would expect?

In the general population?

Yeah, in the general--

You know, I don't-- yeah, I don't have those rates and what our bar should be at baseline, to be honest. I do think that what we see in the end-of-life hospice literature is that there is suboptimal use of hospice care. And what we found was, again, here also sort of suboptimal use of hospice care in this diverse, low-income, Medicaid population.

No, clearly, clearly, definitely so. What are some reasons why Medicaid patients would be more likely to have aggressive end-of-life care, do you think?

I think Medicaid patients sort of broadly often have higher rates of comorbid conditions when they're diagnosed with cancer. There are complex social factors related to the Medicaid population in terms of being low-income, in terms of other social determinants of health and social needs that increase barriers to care or barriers to high-quality care or continuity of care.

In another paper that we published that focuses on this data linkage in the population and this data linkage, there was a lack of primary care utilization prior to cancer diagnosis as well as a lot of the cancer patients in Medicaid enrolling in Medicaid upon diagnosis, right? So I think that there are sort of just several multi-level factors that contribute to why there may be higher rates of aggressive end-of-life care.

I think, from a patient perspective, there is a literature out there on the need for communication tools and sort of interaction and inclusion of caregivers that are a part of the decision-making in end-of-life care. Certainly, we've seen in the literature for a while the issue of providers and providers not only being sort of culturally competent or racial and ethnic concordant, but having the tools that they need, both for the physician or the health care team, to have these end-of-life discussions. So I think it's very multi-level and certainly not just either on the patient or the physician.

Even within the Medicaid population, so independent just of the, say, the financial pressures that would lead one to enroll in Medicaid, what you showed was that non-Hispanic Black patients had a much higher rate of aggressive end-of-life care even than the overall Medicaid population. And why do you think that would be true?

Yeah, so after we finished the analysis for this, we definitely did reach out to other colleagues who have worked in the communities more closely within New Jersey, within the non-Hispanic Black population across New Jersey. We've also talked to our state Medicaid program to, one, think of sort of action items for how to better understand what we're seeing in the quantitative administrative data here, and then two, how to engage communities to understand what to do next about this.

So from the literature and from sort of racial/ethnic disparities literature, we do know that there is often mistrust of the medical system. There's underutilization of preventive screenings, and there are physician biases and structural biases that occur along the way, so again, the multi-level factors that impact why there may be disproportionate aggressive end-of-life care in the non-Hispanic Black population. You know, we can't answer those questions with Medicaid claims and enrollment files. We can identify these patterns.

And I think what our research team has been in communication with our state Medicaid program to do next is then figure out, how do we talk with some of these communities across the state to figure out what the appropriate community-level education tools might be needed to improve an understanding of what end-of-life options are, but also to focus on the hospitals and health care systems that may be disproportionately seeing some of the-- that may be seeing higher proportions of non-Hispanic Black patients, and how can we engage the health care teams within those settings to figure out what can be done at the health care delivery level?

Do you think we have enough information to make interventions now? I mean, are there-- how do you think, aside from further study and trying to understand it better, we might, in the short term, improve rates of quality end-of-life care in these high-risk patients?

We've seen-- and we've talked about this, I think, in this field somewhat-- is, one, there are guidelines. And just having health care teams, providers, hospitals understand where they are, sort of tracking where they are in rates of aggressive end-of-life care and in hospice enrollment, and having that feedback and audit loop to kind of look introspectively within the health care delivery setting, I think is one option that we've seen in terms of trying to increase quality and increase adherence to guidelines for other things.

And then I certainly think that there might be a need for community-level interventions around, what are the barriers to hospice enrollment? Or where is the lack of awareness and knowledge around end-of-life care options? And what does it mean to reduce interventional care, right? And what does it mean for communities? I think that targeting those aspects and having a dialogue that is responsive to the community-level needs are probably ways that we can start.

I think that makes sense. I mean, as an oncologist, a city with a high minority population, I think improving the cultural competence and being able to establish a level of trust with patients who may have an inherent distrust of the medical system, especially when you're talking about something like that's as counterintuitive as trying to recommend not doing more aggressive care, it's certainly a complex conversation and definitely would require a level of trust and communication in order to do that properly. So I completely agree with you that I think, on the community level, the interventions will have to involve that if it's going to be effective.

So Dr. Tsui, thanks so much for joining me on the podcast today.

Thank you for having me.

And until next time, thank you to our listeners for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JCO OP podcasts are just one of ASCO's many podcasts programs. You can find all the recordings at podcast.asco.org. The full text of this paper will be available online at ascopubs.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice, signing off.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

For more original research, editorials, and review articles, please visit us online at jco.org. This production is copyrighted to the American Society of Clinical Oncology. Thank you for listening.

Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at The Cleveland Clinic and consultant editor for the JCO OP.

I have no conflicts of interest related to this podcast, and a complete list of disclosures is available at the end of the podcast. Today, I'd like to talk a little bit about the impact that physician shortages can have on cancer care in the United States.

While there are some parts of the country, for example Boston or New York, where you can't turn around without tripping over a specialist in some field or another of medicine, for much of the vast geographic expanse of the United States, especially outside of larger cities, there's areas that lack adequate specialty physician coverage, perhaps having either small numbers or even a single practitioner covering large areas.

Now, this is very important for patient care because most cancer patients get their treatment in community settings closer to their home and not at large academic centers. But how does this impact care when, for example, specialized surgical services are needed and no one's available close to home?

With me today to discuss this topic is Dr. Jan Franko, chief of the division of surgical oncology at Mercy One Medical Center in Des Moines, Iowa. We'll be discussing his paper, Effect of Surgical Oncologist Turnover on Hospital Volume and Treatment Outcomes Among Patients With Upper Gastrointestinal Malignancies, which is currently in press at the JCO OP. Welcome, Dr. Franco, and thank you for joining me on this podcast.

Thank you for this opportunity, Dr. Pennell. It's my pleasure. I do not have any conflicts of interest with this work.

Thank you for that. So we hear in the media about shortages of physicians, especially in underserved areas. How common would it be that a larger community hospital would lack access to, say, a surgical oncologist?

Just to give you an example, the city where I practice currently has about 750,000 people with surrounding suburbs. And we had a shortage of surgical oncologists for about two years, where I can recall that one of the large hospital systems lost entire radiation oncology department. So for nearly two years, until they hired three new radiation oncologists, they actually could not do any radiation. We ourselves have been a flagship for many decades for gynecologic oncologists.

We lost one about three or four years ago and since then we can't hire, and then on top of that, I recall that about three years ago, we had one year where 90% of urologists left the town. After 12 urologists, about eight or nine had to leave, and they came back for different practice within the same locality. But it was about a year plus without adequate urology workforce. So these things do happen.

No, I could imagine, especially for specialties that are relatively small to begin with. And just to put this in perspective, can you explain a little bit about what exactly is a surgical oncologist, and how does that differ from, say, a general surgeon who may also do some cancer surgeries?

So thank you for this question. I mean, I myself am a surgical oncologist. And I suspect there will be a lot of different definitions. For me, it's would be a general surgeon who is focused on a cancer treatment. General surgeons do treat both cancers but also trauma and general surgical conditions, common gallbladders, hernia.

But a subset of surgeons have focused on cancer. And the majority of those have accredited fellowship. These surgeons, in my opinion, should maintain a broad spectrum of practice. For example, not only liver and pancreas but liver, pancreas, and stomach and esophagus and other organs.

And what's also very important for them is to cultivate multi-specialty understanding of how to transition the care between an operation, systemic therapies, and radiation oncology so they can maintain a momentum of cancer control and [INAUDIBLE] surgery or avoid an operation. And when it comes to the question be able to execute even the complex operations.

And given the complexity of cancer care these days and how multidisciplinary it is, I would imagine that most surgical oncologists are centered around academic university hospitals as opposed to working out in more rural areas or community hospitals. Is that the case or are they pretty much available everywhere?

So indeed, you are right. It, in fact, was published in the Annals of Surgical Oncology around 2018 and 2019. An absolute majority of surgical oncologists are centered at the university hospitals or NCI-designated cancer centers. The number varies, but for example, in Iowa, more than 80% of such a workforce is concentrated in the single university center, which is outside of our town. And that number ranges from approximately 65% up to 90% of surgical oncologists working for the university, not the community hospital.

That makes sense. If you were a patient who needed specialty surgical care for, say, pancreas cancer or esophageal cancer and you didn't have a hospital with a surgical oncologist nearby, what do they usually do? Is this something that's handled by a local surgeon or do they travel to academic centers to get that care?

So this is subject of lots of research. And I think there is a dramatic geographical variation. And also there is a variation depending on the patients and their socioeconomic status and understanding of the situation. Plus, another question which is not discussed, how long is it reasonable to travel? How far?

So I do think that complex surgical therapy should be done by people who do have experience in that. And what is experience that can be defined by number of cases, but does doing 10 pancreases improve you in operating on the stomach as well, I would believe there is some degree of cross-fertilization. Is it reasonable for people to travel for an operation 100 miles, 150, 200? Probably not reasonable, as long as they get a quality care closer to home.

Yeah. It certainly would put a burden on them, and you could think that their follow up care might be compromised by being so far away as well.

Yeah. I agree with that. One has to understand that the discharge from the hospital after operation by far doesn't mean end of the surgical care or at least it should not. Patients are these days discharged from operations very quickly. Various tricks, sometimes surgeons let them stay in the town in a hotel, which I don't know how good discharge that is.

But then they're coming back for unexpected postoperative either complications or troubles, which do not amount to major complications, that has to be readily available. So there are mechanisms how people can do that, but can you really do it on a distance of 100 miles?

With that in mind, can you take us through your study? What were you trying to show?

Thank you. This was almost classical before-and-after study. But it was not only before or after but was before the last surgical oncologist and the short period of time that we didn't have it. And the largest period of time when we actually regained surgical oncologist, which is how I came to the local practice. And I'm still practicing here for about 12 years.

So the whole study spanned over about 15 years, between 2001 and 2015, and looked at the patients who are typically taken care of by a surgical oncologist and not focusing on the technically rather simpler procedures on, let's say, skin cancer. So we focused here because of complexity and inherent risk on the esophagus cancer, gastric cancer, and pancreatic cancer.

For reason of this study we looked at carcinomas only and excluded neuroendocrine tumor, benign conditions, gastrointestinal stromal tumors, and others. And we only focused on those conditions which could be potentially resectable, because otherwise there is no practical influence of surgical oncologist for a majority of therapy.

So for esophagus and gastric cancer, we looked at stage I through III and for pancreatic cancer on stage I to II. Stage III, in general, historically was never considered for an operation. Might be changing currently, but it was not in the past.

So in 2006, our prior very excellent surgical oncologist simply retired. And the next two years, very clearly, there was no surgical oncologist in the hospital. And they observed the proportion of these diagnoses, and they observed that during the time that there was no identifiable surgical oncologist responsible for advising and executing surgical care on those patients, the number of referral cases dropped dramatically down.

Some went down from about 12.2% of these cancers diagnosed within this hospital as compared to the state, to down to only about 6.7% of all state cancers being diagnosed in that particular hospital, which at that time was missing surgical oncologist.

Once the new surgical oncologist, which was myself coming back, was able to restore those services or perhaps the confidence of referring physicians and the society at large better, and it returned back to the prior numbers, again diagnosing and treating approximately 12% of the state volume of these neoplasms.

We also wanted to see if we could not compare that to SEER database within the state of Iowa, that we obviously asked the question, did the number of these cancers for those two years somehow decrease in the state of Iowa? And it did not. So at the state level, there was maintaining of the trend of the annual diagnoses, but in the particular hospital they were not apparent there.

So we assumed that they out-migrated to other institutions. And empirically and by discussion by other physicians who were here in this time, they clearly out-migrated to different systems and out of town. They were simply not present with this hospital.

We looked at the overall survival as perhaps the most important measure of efficacy of therapy. And we were able to restore the surgical oncology quality to the point that survival after the new surgical oncologist came was not worse, perhaps even improved in some situations.

And there also was more of a higher proportion of patients undergoing multidisciplinary therapy. That means either chemotherapy or radiation or combination of those in addition to surgery. That will be expected general trend over the last 15 or 20 years, but it was very reassuring. We could actually see it to be restored back once the surgical oncologist services became available.

And how well do you think the overall state SEER numbers reflect the real results that you would see in your patient population there?

I think it reflects very tightly about the reality. Now, SEER has been demonstrated on a nationwide level to be very effective and very precise with a very low rate of the errors. Interestingly, and many don't know that Iowa was one of the original states where the SEER Database has been established and participated in the program since 1973.

And to some degree, it could be driven by the fact that there are not too many hospitals which actually have cancer registry. So in reality, you don't have to train that many registrars. But those registrars and individual cancer centers actually support both the SEER Database and other databases, including the National Cancer Database.

So there is historically, for perhaps some nearly 50 years, of consistent reporting of data. So I have a lot of trust in the data reported, especially from Iowa.

In the paper, I noted that you, over time, as we get closer to the modern time, that the outcomes seem to improve. At least compared to the time before the previous surgical oncologist was there, is that because the new surgeon was more skilled or is it that outcomes just overall are improving as we move on and have new treatments?

I think it's completely explained by the overall improvement of care of the years and multidisciplinary treatment. I had a distinct pleasure to, for about two or three operations, operate with a surgeon who continues to work in Iowa-- he's in mid 70s-- in the minor procedures, and that's an excellent surgeon. Definitely could observe it. So while many people like to think that it is because of one person or one surgeon, there's not one surgeon. It is really the whole system maintain adequacy compared to improvements, which we experienced over the last 15 years in the care overall. So I think it's the whole team, as it would be expected, gets better over time.

I think you did a very nice job of illustrating the major impact that losing a surgical oncologist has on our health system. Dramatic changes in the numbers of patients treated over time. So is there a message that health systems who maybe have only one or a couple specialists in various fields can take from this? How should they be addressing potential loss of their relatively small numbers of crucial specialists?

I think this is great point, and all that I can advise would be consideration and planning. And while I do think that some specialties with low frequency of practitioners, like surgical oncology, are at risk, there are many other specialties.

And, in fact, every single specialty could be at some degree of risk, because a medical oncologist, the level of the knowledge which is required to practice with all the molecular studies and immunotherapies is enhancing, essentially doubling every year or two. So sub-specialization within even medical radiation oncology is also ongoing.

So I think every health care system is at a risk of losing some portion of its common skill if a key individual is to leave. So surprisingly, as I mentioned at the early parts of our podcast, we actually lost, not in our hospital but in another large hospital, an entire group of radiation oncologists. Hard to believe that it occurs in a city of 750,000. But it did happen.

So I think that planning and perhaps more research and attention into who delivers care, not only how, but who delivers the care, into how do we cultivate our cadre of nurses, physicians, nurse practitioners, or extenders, it becomes extremely important, perhaps at least as important as the buildings, because it's really the professionals who create the program.

And those gaps-- you know, I definitely experienced this gap. I came and I thought I would take over a working practice. There was no practice. That is not necessarily important about me, but what about the community which actually experienced this decline?

And I would submit that every health care system in some form or another, whether large or small, is in some degree of a risk if they do not address the planning, career transition of the services which are often perceived as granted and available until those who do them are actually not present.

Dr. Franko, thanks so much for joining me on the podcast today.

Thank you very much, Dr. Pennell. It was my pleasure.

And for the listeners out there, until next time, thank you for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen.

While you're there, be sure to subscribe so you never miss an episode. JCO OP Podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of this paper will be available online at asco.org/journal/op. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

Welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO podcast network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. my name is Dr. Nate Pennell, Medical Oncologist at the Cleveland Clinic, and consultant editor for the JCOOP.

Today, I'd like to talk about sex disparities in academic oncology. Despite increasing attention in recent years, sex disparities in academic medicine clearly persist, and are most noticeable at the more senior and leadership positions within academic centers. While these disparities are well recognized, in general in medicine, what exactly is known about sex disparities in academic leadership in oncology specifically?

With me today to discuss this topic are Dr. Faisal Khosa, Associate Professor in the Department of Radiology at Vancouver General Hospital, at the University of British Columbia; and Dr. Ariela Marshall, Associate Professor of Medicine and hematologist at the Mayo Clinic in Rochester, Minnesota. We'll be discussing their paper, "Sex Differences in Faculty Rank and Leadership Positions Among Hematologist and Oncologists in the United States," published online in the JCOOP in February 2020.

Welcome, Faisal and Ariela, and thank you for joining me on the podcast.

Thanks so much for the invitation. We're glad to be here.

So how big of a problem is sex disparities in academic medicine, in general?

I can speak to that a little bit, and then certainly Dr. Khosa also is a world leader in this area. So he can add on to what I have to say. So I think we well know that this is a problem across the board, regardless of specialty, regardless of whether we're talking about academic rank, or position on editorial boards, or any number of other leadership positions. So we see the huge drop-off between our current medical school population, which is actually over 50% female as of the last couple of years, but then a sharp drop-off over time when we get up the ladder to then in the associate and then the full professor level, as well as positions like being hospital CEO, department chairs, and any number of other leadership positions. And I'd certainly like to hear what Dr. Khosa has to say as well.

Nathan, thank you for inviting my participation on this very important topic. I would also like to add that I have no personal or institutional conflicts of interest with this publication that we are discussing, or this particular interview that is being recorded now. I would also like to thank Dr. Irbaz Bin Riaz from Department of Hematology Oncology at Mayo Clinic, who spearheaded this project successfully, and is also the first author on this manuscript.

Yeah. Thank you for clarifying that.

I agree with Ariela's comments. Women are underrepresented in high academic ranks and leadership positions, in spite of more than 50% matriculants from medical schools across North America, US, and Canada are now women. But they represent fewer than 20% of medical school deans and department chairs. Furthermore the American Association of Medical Colleges data reveals that female physicians make $0.76 for every dollar earned by their male counterparts. And this is even after adjusting for age, experience, and discipline of practice.

Women report difficulty finding mentors and are significantly less likely to receive sponsorship. Now let me explain the difference. Mentorship is critical to the development of leadership skills or abilities, while sponsorship is a necessity to enter into leadership positions.

No. That certainly makes sense that that would be a significant barrier to academic success. I think it's interesting you mention that women now make up approximately half of physicians in medical school. I went to medical school starting in 1998, and already more than half of my class was women. Why do you think they're still seeing this disparity 20 years later?

That's a great question, and I think we can delve maybe a little bit into our paper here, in terms of what we found in hematology oncology. Because I would imagine that some of these findings are kind of similar across the board. And so what we observed here in this study is that we did see that sharp drop-off in number of associate and full professors. So what we saw, about 45% of women were assistant professors. Only about 36% of the associate professors were women. And only about 22% of the full professors were women. So there's definitely that drop-off over time. And also only about 30% of department leaders were women.

And so one thing that people bring up a lot is just time. Right? So the time to go from assistant professor to associate professor to full professor, is not measured in months or even a couple of years. It's measured in the 10, 20, 30 year time frame. So somebody say that that's probably a big driving factor, is that what we're seeing in medical school has not yet caught up, with what we're seeing in leadership positions that take years-- probably 20, 30, 40 years to achieve.

But the other thing that we can talk about a bit later is it's not just time. It's the fact that people who have those positions may stay in them for 10, 20 years, and not leave room for other people to get into those positions. And also there is differences in how long it takes women to get promoted. And if you have to achieve a certain academic rank to get one of these leadership positions, then there may be delays of women being able to do that for a number of factors that we could talk about.

There is one more factor, which is less obvious, but equally challenging, which perpetuates the problem that we are discussing here. If you look at appointment and promotions in academic medicine, and I have been fortunate that I've practiced in Europe. Then I practiced in US. And now I practice in Canada. And all my practice has been in academic institutions. Whenever somebody is being shortlisted, selected, interviewed, appointed to an academic leadership position; the sole or entire or 90% or 99% of the focus is on that individual's performance of publications, of grants, of collaboration.

Nowhere is the consideration given to a person or individual's track record, for advocacy for equity, diversity, and inclusion. Now such an individual gets into the leadership position, now they are handed a memo saying, you have to ensure equal opportunity, and you have to make sure that minorities are appointed, women are appointed, they are promoted. Now such an individual does not have innate interest, or understanding, or even expertise in equity, diversity, and inclusion.

So previously what was a bottleneck of barriers to entry for women and minorities, has now become a bottleneck and barrier to promotion and leadership positions. And this is a subtle undertaking which people overlook when they are selecting people for appointment positions.

No, I think that's a-- I hadn't thought of that. But that's a very significant factor I would think. And this gets to the larger topic of how we choose our leaders in academic medicine. We don't necessarily choose people based upon skills in leadership, and training in leadership, but rather on personal success in whatever their academic field is, which does not necessarily lend itself to being able to do the job that they've now been appointed to. Can you take us through how you designed your study?

So we started off with publicly available data. And the first thing we did was here [INAUDIBLE] we went to the website, looked at institutions that offered residency and fellowship training, because those were academic institutions by default. From there, we actually downloaded or created the lists of programs, and then visited the website of each program to obtain the list of their faculty from department chair down to the level of assistant professor in hematology and oncology. We looked at leadership positions-- director, associate director, division chief. We also looked at practice type, whether it was university, whether it was community, whether it was a combination of the two. We looked at a number of trainees. We looked at the geographic location, like state of the practice.

In addition to that, we also looked at whether it was an MD or DO, whether it was an international medical graduate faculty, the year since medical school, year since the residency, number of publications, the number of grants, the number of clinical trials, the number of first author publications, number of citations. So we made it as comprehensive as possible from our experience of what it takes for academic appointments, and what is considered vital for academic promotions and to get people into leadership positions.

Yeah, that was one of the things that I wondered, is how one really measures this. And it sounds like you did a wonderful job of trying to identify, as best you could, objective measures. There probably isn't really a way to measure bias about sex differences in appointments. So you would have to look at this using these objective measures.

I agree, Nathan. And let me add to that. What is normal? You know, we talk about normal. Normal is an illusion. What is normal for the spider is chaos for the fly. So there are many things that are tangible. Then there are many things also that those are intangible. So we can only study what is objective or objectively can be calculated or measured. But in this equation, I'll give you an example. You look at the interview panels, and most of them are males, right?

Now how are you want to configure bias in that room when a female comes in to interview? Automatically people going to presume, oh, she is married. Automatically people are going to presume, oh, she may have kids, or may she may not be able to do justice to this leadership position, this chair position or what have you. And those are things that are going on in people's heads. There is no way that you can shine a light on that.

Of course. Of course. Although, in a way you do that by trying to match everything as objectively as you can, and seeing if there's still a significant difference at the end. OK, so why don't you start taking me through what you found?

So I talked a little bit about what we had observed in terms of that drop-off in the numbers or the percentages that we see women who were of higher academic rank, and the associate professors, and then only 22% being full professors, and only 30% being leaders of their departments. We did also find that women had lower h-index. So what we could tell in terms of an objective measure of research productivity, although of course that's not by any means a perfect measure, and they also had fewer years of professional experience and fellowship; which again speaks to the fact that while there is parity in gender in medical schools currently; in terms of practicing physicians, there's still this gap.

And then we looked at the odds of obtaining full professorship or leadership of a division, after we adjusted for how long somebody had been in practice, what their productivity was; again measured by the h-index, so not the most perfect measure. And we did not find actually any differences based on sex and the odds of obtaining either professorship or divisional leadership. So again, one could call this a, quote-unquote, "negative study," and that, OK, if you correct for enough of these factors, there don't appear to be sex disparities in women being able to achieve leadership or to obtain higher academic rank.

But I think a very important thing to note is that's not the point we want to be making with this study, is that, oh there's no gender difference. There's no sex disparity here. We want to point out that this is the real world. In the real world, we don't correct for things like clinical experience and academic productivity. You can't do a mathematical correction. What we need to see is why are there things like difference in academic productivity. What are the factors that may make it more difficult for women to be able to achieve these ranks over time? What are the barriers that they're facing, and how can we try to overcome them? Because we're not in a mathematical world, where we just correct for these things, and we need to help our system change to allow women to achieve these positions of leadership.

Yeah, I'm glad that you pointed that out. Because my first read of the paper was actually, wow, they're actually concluding that there isn't a big gender difference, or a sex difference in senior leadership. But as you actually read in, there clearly could be disparities in terms of women being able to achieve the same numbers of publications, and equally high h-index and grant funding that would get them to the point where they would be in a position to get these leadership positions. So the disparity extends well beyond those positions themselves.

There's a lot of data out there that women are funded at lower rates for initial grants. And of course, you know that once somebody gets a grant, they're more likely to get other grants in the future. So putting that barrier in place from the beginning makes it harder for women to get grants over time, makes it harder for them to get published. We know that editorial boards have a lot of sex disparity. We know that as Dr. Khosa also said, there are sex disparities in leadership who are making decisions about who gets promoted. So there are all these unseen variables that we can't account for that are probably barriers to achieving these higher leadership positions.

This is something that always comes up when we talk about barriers to women moving up in leadership roles, that they may be earlier in their careers focus to some extent on raising a family, or even if they are continuing to work without a break, that they have a disproportionate share of family and home care obligations, and that this may lead to lower academic productivity. And therefore some of the measures that go into leadership promotions may not be as prominently featured on their CVs for these reasons. And so do we need to think differently about the criteria that go into promotions?

Exactly. And that's one of the points that we both wanted to make while talking with you today, is that as the saying goes we need to fix the system, not the women. For a long time, when we were told you just need to work harder, be more productive, you need to essentially "be like a man," quote-unquote. We're in a system that was developed by men, run by men, and have criteria that allow men to get promoted. And so if we apply the same criteria to women, we're essentially telling them, you need to behave like a man in order to succeed in the system. So we don't need to tell women to be like a man. We need to change the system to be more friendly for everybody.

And so that does involve things like changing what criteria we look at for promotion. As Dr. Khosa was saying, why are we just looking at the number of publications on a CV? There's a lot of other things that women do that actually make a big contribution, whether it be seeing a higher number of patients, whether it be serving on committees. We know that women are more likely to serve on committees than men, and committees are things that are unrewarded on your CV that take quite a lot of time and effort to do. So there's all these unseen things that women are doing that don't make it onto the CV as a criteria for promotion that we really need to take a much harder look at.

And at the same time, we also need to be changing the system, and to say, what are we doing wrong that allows women to be paid less than men for doing the same tasks? What are we doing wrong that we are funding women at a lower rate than men when they submit grants? What are we doing wrong that allows our editorial board and journal reviewers to continue being primarily men? So we need to really make some changes to the system, both from what supports women, and from how we judge people on a criteria for being promoted.

How do we do that, though? So I think now I mean it's hard to escape that this is a real thing. I mean you've objectively shown differences. It's been well-documented. What do we do in order to make this actually change?

I recently published a paper on Canadian health authorities. And out of the 30 manuscripts that I've published and 50 more that I'm working on, this was the only manuscript which showed clarity. There was no disparity, gender disparity. And the reason for that is because it is the governments that have mandated. And there are carrots and sticks. So if an institution's annual evaluation, or three yearly evaluations does not show progress, that institution's funding, government funding, grant funding, capsizes. And these are the metrics that are applied across health care authorities. These are the metrics by which progress is measured.

Giving out policy and not following it through, or not having repercussions is rewarding bad behavior. The best apology is actually change the behavior. That is what best apology is. Similarly, remedial action has to be avoided, and those who could persist with this behavior have to be taken to task. That is the only way.

I'm a huge fan of Dr. Julie Silver from Harvard Medical School, who is a world leader in gender equity research, very well published in this area. And she always says that if you can't measure it, you can't see it. And it's so important to measure these things. Because number one, as Dr. Khosa said, it gives a baseline for improvement. But number two, it really opens people's eyes to say, hey, we do have a problem. I think if you are trying to go to leadership and convince people that we need to implement some changes, we really need to be bringing some data with you. You can't just say, oh, we have a gender equity problem, because everybody knows it.

You need to say, this is our percentage of women who are in leadership positions. This is what's changed over time. This is what hasn't. And here's what we propose to do to fix it. And here's how we're going to measure our success. So you really need that data as a starting point, and as a measuring stick to see how well your interventions are working.

Well, I think that's a wonderful summation. So Dr. Khosa, Dr. Marshall, thank you so much for joining me on the podcast today.

Thank you so much, and god bless. Have a nice day.

Thanks so much for inviting us.

Until next time, thank all of our listeners for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple podcasts, or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode. JCOOP podcasts are just one of ASCO's as many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper is available online at ascopubs.org, backslash journal, backslash jcoop, posted February 2020. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

Support for JCO Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at AstraZeneca-US.com.

Hello, and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP.

Today, I'd like to talk about a topic that's at the front of many people's minds, burnout. With what seems like constant stress and increasing demands on our time, many clinicians are feeling increasingly exhausted, cynical, and like their work lacks meaning. These elements are part of a condition known as burnout. And it feels like everyone's feeling it to a greater or lesser extent these days. While employers and training programs are increasingly aware of the issue of burnout, what are they doing to reduce it or to prevent it from happening in the first place?

With me today to discuss this topic is Dr. Daniel Richardson, hematology/oncology fellow and AHRQ postdoctoral research fellow at the UNC Chapel Hill Lineberger Comprehensive Cancer Center. We'll be discussing his and his colleagues' paper, "Development of an Art of Oncology Curriculum to Mitigate Burnout and Foster Solidarity among Hematology/Oncology Fellows," which is part of a special series at the JCO OP on physician wellness burnout and moral distress. Welcome, Daniel, and thank you for joining me on the podcast.

Thanks for having me. It's really a privilege to speak with you today. I'll start off just by noting my conflicts. I have no financial conflicts of interest to disclose. However, my institution was involved in the study that we'll be talking about.

All right, thanks for that. So burnout is something I think most physicians and other clinicians can relate to. But would you mind just kind of giving our listeners a little brief overview of what exactly is burnout in physicians and how big of a problem is this right now?

Sure. So burnout was first described really as a metaphor to talk about an extinguishing of a fire or smothering out of a fire. And it related to this loss of capacity that many feel to make a meaningful and lasting impact with one's life or career.

More recently, it's been further clarified to cover several domains of this initial concept, including emotional exhaustion, depersonalization, and loss of meaning or purpose at work. And burnout really has been shown to lead to profound of personal and professional consequences-- anxiety, depression, and in the professional realm, attrition among physicians and oncologists and decreased quality of care. And the problem is pretty pervasive, as most of us are aware. Our most recent studies show that nearly half of practicing oncologists are experiencing burnout and about a third of residents, fellows, and medical students even are experiencing burnout.

Yeah, this is what, I think, a lot of our listeners might be interested to hear about. There may be a conception out there that burnout is a function of time-- you know, being exposed to something over a long time maybe later in your career. But what you're saying is that this is something that people can start to experience almost immediately, even in medical school and during residency. And I find that really interesting, although potentially disturbing as well.

Yeah, I agree. And I think what we're seeing is probably the results of a larger change in our culture. We're seeing kind of a loss of sense of meaning and purpose and connectedness to the community in the larger culture. Increasingly, we're seeing that medical students, residents, and fellows are lacking a deeper sense of meaning and purpose in the broader community. And that's really playing out in their role as an oncologist as well.

So I'm curious what led you and your fellowship program to developing this kind of a curriculum to try to combat burnout.

Sure. Prior to medical school, I completed a master's degree in philosophy of religion and ethics. And it allowed me the opportunity to think a lot about virtue ethics and also the moral foundation of medicine. And virtue ethics is really focused on human flourishing and really claims that the path to human flourishing is developing character and virtues that can lead to that.

And so I thought a lot about who I was becoming as a medical student, who I was becoming as a physician in medical school and then into residency. During my first year of fellowship, I was thinking a lot about the culture of medicine and how I was developing in the midst of that. And I really became aware that there was a clear lack of direction on how to help fellows develop into oncologists that would be able to thrive in their careers.

We didn't really talk about calling. We didn't talk about purpose. We didn't talk about who we were becoming. We were being trained as oncologists with the right answers about treatment. But as one of my favorite authors, C.S. Lewis, puts it, we were at risk of developing into oncologists without chests-- that is, without a deeper understanding of the meaning and purpose of what we did each day. It really kind of started with this bigger understanding that we were going through this big process, and we were becoming oncologists without really thinking about what that process was looking like and how that was happening.

Wow, I think that is-- that's fascinating. Well, in any case, since this led you to design the program, can you take me through the design of the Art of Oncology program that you designed? And what are you hoping to show as a result?

Sure so as I had mentioned, I was really thinking a lot about who we were becoming as oncologists. And so one of the first things that I thought about is, how can we foster a sense of meaning and purpose in our fellows. I thought that this was really a place where we are seeing a lot of burnout is that there is this lack of meaning and purpose among fellows and oncologists in general. And so we wanted to target that. So we landed on a curricular intervention that used narratives, really to promote a shared mental model of meaning and work, which all that really means is helping all of us have a discussion to understand where we are coming from, our experiences, and how we are being shaped in the midst of kind of caring for patients. And our hope in kind of starting from that point and developing a narrative model was really that we could help fellows understand where they sat in caring for patients, their calling in doing that, and then also their position as a part of a broader community that had a bigger vision for caring for patients as well.

So we decided that we would use personal and published stories, mostly about caring for cancer patients, to spark discussion, reflection, and then really a deeper understanding among fellows of this shared calling. And we had faculty or, often, patients come and share their story or one of the narratives in those sessions. We planned eight sessions throughout the year, which took place during the traditional didactic lecture times. And the narrative took place over the first 15 minutes or so. And then the point was really to foster this deeper discussion and reflection on meaning, identity formation, and moral development in medicine.

So a lot of this really was based, then, upon selecting the different essays and other pieces of literature that you were discussing. So how did you end up picking those?

That's a great question. And I think we wrestled with it a lot. I think initially, we, as a group, found those essays that were most meaningful to us. And we felt like they would really speak to the fellows. But as we thought about it more, we really wanted to collect them around a few themes. And as I've been talking about, I fundamentally believe that finding meaning in caring for suffering patients is essential to mitigating burnout. So this was kind of the primary theme that I focused on.

But we also, in the midst of the program, wanted to equip fellows with skills to foster their sense of purpose in medicine. So we had a session focused on cultivating virtues of resilience and self-care, as well as sessions on caring for dying patients. And we really understood that the experiences of most fellows were very hard, given the immense amount of suffering that they experience.

So our initial hope would be that really, this session and this program would be an avenue to redeem some of the suffering that the fellows were experiencing through their patients. We hoped that it would lead to a deepened sense of community or solidarity is the word I use in the paper, among our fellows, and that this sense of belonging in one's profession really becomes vital for the sustained success. And I was really hoping that this would be fostered in the program as well.

You had mentioned earlier about what you were hoping for. Although we knew that we wanted to target a reduction in burnout among fellows, we recognized that burnout is really a multifaceted concept. So we knew that a small pilot program would be unlikely to see a substantial improvement in burnout. But we wanted to really shoot our or our aim our intervention really at the roots of developing burnout over a career.

So how did you try to measure that? So I mean, first of all, I've got to say, this sounds amazing. And I could say it may have value just in and of itself, because it's such an interesting and cool concept. But as scientists and trying to study things, how would you measure this kind of improvement?

Yeah, so that is probably the fundamental challenge, to be honest. And I, first off, want to say, I 100% agree with you. I think it's a first principle of medicine that we need to, as a community, think deeply about how to care for patients well. And we need to help each other to thrive in medicine. So I don't know how you'd necessarily capture that on a scale.

There are well-developed burnout scales, the NBI being the most prominent. We worry a little bit about having our fellows go through extensive surveys in the curriculum. So we used a couple surrogates. So there are three one-item measures that we used at the beginning and then the end of the curriculum.

And then we really wanted to capture the experience of the program as well. So we had fellows fill out basically subjective surveys about their experience with the program. And then also, we captured their attendance in the program. Our aim was really to establish, first off, is this something that is possible to do, good fellowship programs do this. And then really, did fellows enjoy and participate in the program as well.

You mentioned about not wanting to put a bunch of surveys on top of people. And so one of the first things that occurred to me when I was reading this paper is, were you concerned when discussing adding this that fellowship curriculums are already quite busy and filled with lots of sessions and other duties and whether this might actually make their burdens worse by adding extra sessions and requirements?

Yeah, for sure. We didn't really know what to expect. And we didn't even know if the Fellows would show up and participate. There is fear within our culture of being vulnerable, of owning that the suffering of our patients is getting to us and that we need some help. And I was really afraid that fellows would feel like the sessions were cheesy or forced and that the fellows would be uncomfortable being honest in the sessions.

There is a perpetual concern about adding more into the lives of fellows that will lead to greater burnout. You know, it's the running joke about filling out a weekly 25-question burnout survey among our fellows. So we really wanted to design a program to limit the requirements. Fellows really just had to show up and participate. There is no required readings or homework.

And we limited a few didactic sessions that used to be in the place where the Heart of Oncology sessions were in order to make room in the schedule. And we tried hard to make the sessions adaptable to any environment so that it was really just having a narrative prompt, getting people who care for cancer patients together, and thinking deeply about some of these issues that was really at the heart of the program. So we tried to limit a lot of those extra requirements for the program.

Well, it sounds like you definitely thought about that and tried to make it as least burdensome as possible. And it sounds like you were able to do that. So tell me, what did you learn from this first year of the program?

Well, it was really fun at first. And so as a fellow myself, I was able to participate with the other fellows. And that was really wonderful. I had a great time with them and learned a lot about them and felt like it was really enriching for me.

We saw, really, that the fellows really enjoyed the curriculum as well. They really loved the opportunity to think more deeply about these issues and also to hear how their colleagues were wrestling with them and to dialogue about some of the issues that we often don't talk about. They felt it improved the sense of community among the fellows and helped with some of the daily challenges of dealing with the suffering of their patients.

They pointed to some practical skills that they took away from the sessions, including managing work-life balance, communicating bad news, and having a better understanding of the challenges faced by patients. Surprisingly, many of the sessions were really emotional for the fellows, where they were able to share their stories about losing patients or family members to cancer.

We didn't see a statistically significant improvement in burnout. And as I mentioned previously, this is a pilot intervention. So this is not wholly unexpected. As you mentioned prior as well, that with such positive comments from the fellows that the sessions were beneficial in and of themselves, and really that we would hope that there would be long-term benefit as well. I don't know if such programs to foster moral development would actually be expected to result in immediate improvements in burnout. So the goal was really to begin to cultivate the virtues that will have lasting impact over a career in medicine and not necessarily to impact the burnout that follows were experiencing in that moment.

So you are describing the first year in your paper here. So what are the next steps? And based on what you've learned, are you planning any changes?

Yeah, so Dr. Collichio and I sit on the ASH ASCO Milestones committee, which are working to develop some metrics to capture fellow well-being at each fellowship program. And so we are hopeful that these metrics begin to lay a foundation to expand the art of oncology programs and other fellowship programs. We've been in contact with other programs that are eager for such an intervention and to get it rolling. And so I welcome other fellowship programs to join in as well.

The ideal study design to test this intervention is a multi-institutional cluster randomized trial. But really, I think we're still at the nascent stages of the development of such interventions. So this will likely be something that will happen years from now. And again, I think we realize that while we want this intervention to really impact on burnout, we want the intervention to have something deeper in terms of developing the character of our fellows. And so rolling it out among fellowship programs is going to have benefit across the board.

So what changes are we making to the program? We're in the second year of the pilot. And we haven't had too many changes, apart from, again, limiting the amount of requirements that we have for the fellows. Last year, the fellows really loved having patients come and speak and share their stories and how they interacted with the health care community. So we increased the number of times that patients would be coming. And we started to have more of our senior oncologists come and share their journey in medicine, kind of a career perspective to the fellows, and allow them to really begin to build some mentoring relationships.

Well, Daniel, I think this sounds absolutely fantastic. I wish we had something like this when I was going through fellowship training. So Daniel, any closing thoughts before we wrap up?

I'd like to comment that programs like these are simply part of a larger whole. Much of the increase in burnout we are seeing in medicine, as I mentioned, is part of larger societal epidemic of the loss of meaning and purpose for individuals. I believe that the epidemic of burnout in medicine is not going to simply be reversed by programs, but rather by a deeper change in the culture.

As an oncology community, we need to recapture our calling of service to suffering patients. We need champions who can lead the way in this and serve as mentors for fellows on how to care for patients well and to model how to find joy in their careers despite the suffering and losses they experience. It is only by recapturing this deeper calling that we can inspire and train fellows to do the same. And I'm hopeful that programs like this one and other similar programs across the country to bring fellows together to think deeply about their calling, their personal calling, and then also their calling in the midst of the oncology community, will serve to do this as well.

So Daniel, thanks so much for joining me on the podcast today.

Once again, this is such a privilege. Thanks so much for having me.

And until next time, thank you for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JCO Oncology Practice podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper is available online at ascopubs.org backslash journal backslash JCO OP, posted in February 2020. This is Dr. Nate Pennell for the JCO Oncology Practice signing off.

Hello and welcome to the latest JCO Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs, covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org. My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JCO OP.

Lung cancer is a huge public health issue. It's our number one cause of cancer-related mortality, and a big reason for that is the lack of a widespread screening tool which results in most of our patients ending up with advanced disease at diagnosis. Although, low-dose CT screening has been proven to reduce deaths from lung cancer for a number of years now, uptake among eligible patients in the United States is very low, well under 10%. Part of the problem may be a poor understanding of the risks and benefits of screening CT, despite broad recommendations for shared decision-making between providers and patients.

Why is uptake such a big problem, and can shared decision-making be improved to help increase screening rates? With me today to discuss this issue is Dr. Lisa Lowenstein, assistant professor in the Department of Health Services Research at the University of Texas M.D. Anderson Cancer Center. We'll be discussing her paper, Implementing Decision Coaching for Lung Cancer Screening in the Low-Dose CT Setting, to be published in the February 2020 JCO OP. Welcome, Dr. Lowenstein, and thank you for joining me today.

Thank you. It's wonderful to be on.

So can we start out by telling our listeners a little bit about the landscape of screening for lung cancer today and the role that shared decision-making plays in this process?

Yes. I think we're in a very exciting time in terms of lung cancer screening, because this is the first time that we have a screening test for lung cancer which is the number one cause of cancer deaths among men and women in the United States. It's really notable that CMS included shared decision-making in their policies for lung cancer screening, because they recognize that, unlike breast cancer and colon cancer screening, we're changing the game a lot of bit here. So we're saying that only high-risk individuals should be screened. So it's not all-comers, and I think telling people about the potential benefits and harms is beneficial. So they go in being a little bit more informed about what the next steps will be, and it is a complex process, and overall, it's still in its infancy.

Yeah. I think a lot of people found it interesting that, in order to reimburse for lung cancer screening, that CMS required this documented shared decision-making visit which on the surface seems like a very reasonable thing. But do you think that's really helping, or is it hurting?

Lung cancer screening is really in its infancy, and it's a complicated process. So we're not just talking about you just show up, and you show up for a scan. Right? We're not where breast cancer screening is. We don't have mobile scans out there. It's taken decades for those programs to get where they are, and I think shared decision-making is just adding one more step and just emphasizing that it's really a program that you're committing to.

And the other aspect is that we really want to highlight that it's not lung cancer screening is enough to prevent lung cancer. Right? It's just detecting it, if you have it. But the best way you can reduce your lung cancer risk is by not smoking, and I think by inserting the counseling and shared decision-making visit, we're reiterating that message to our high-risk smokers and former smokers. Primary care providers, or any providers, aren't even talking about lung cancer screening.

Two, not a lot of facilities may be listed in the American College of Radiology Lung Cancer Screening registry, but their volumes are very low, and they may not actually have the proper equipment or machines to conduct the lung cancer screening. Third is that, if there is to be something to be found on the scan, we don't have processes in place to deal with all the abnormal findings. So I think those are all the things that providers and networks are trying to figure out, and they're trying to figure out like the cost benefit from the reimbursement issue. Because CMS reimburses this scan for a very low cost, and it's lower than what's reimbursed for breast cancer screening.

That's interesting, and in your paper, you mention that, as of right now, something around 6% of eligible patients are getting screened for lung cancer. Which is disappointing, because the studies have been out for a while now. You mention about some of the institutional issues and awareness and providers. Are there any other reasons out there that are limiting this? Because this is something that should be saving lots of lives, and so far, it just seems like it's not making much impact.

I think so, and I think it's misguided in some sense. The reimbursement is not-- you don't have to submit a reimbursement for the counseling and the lung cancer screening. A screening facility can still be reimbursed for the scan without the 1 to 1 ratio of a counseling in shared decision-making billing code, if that make sense.

That's interesting. I didn't know that.

Yeah. So the reimbursement is definitely not going on 1 to 1. I just think, it's a complicated process, and if you were doing a study in Texas and we're serving as many screening facilities as they can in Texas, and I can tell you, a number of them are not doing a high volume of scans. And a lot of primary care providers are trying to find screening facilities that are doing low-dose CT, and it's really hard to navigate the American College of Radiology Lung Cancer screening facility to find a facility. It's about 15 to 20 clinics or something like that.

Wow.

So we tried to look for it on a number of occasions, and it takes us multiple tries every single time.

Well, it's obviously a complex issue, and there's more than one reason for the low uptake. What was the specific issue that led you to do this particular study, and do you think that improving shared decision-making can improve uptake on lung cancer screening?

I think the main issue that we were trying to address here is that, one, we recognize that primary care providers may not be the best-suited individuals to provide the counseling shared decision-making visit. Instead, they may just want to do more of a referral process, like what they're doing in the Cleveland Clinic. Right? Where they say, somebody's potentially eligible, so I'm going to send you to a one-stop shop type of setting. And our radiologists who are leading our lung cancer screening program really wanted to start building this and test it out as an alternative delivery model for the counseling shared decision-making visit which wasn't proposed by CMS or the task force recommendations.

So can you take us through your study design?

Sure. So it was really a pre/post kind of study, really with a quality improvement mindset, as well as using some elements of implementation science, so we can make it relevant more generalizable in our findings. But we first had our period of where they just did what they normally do, where the patients show up. They go and have their scan. They have their normal intake process, and that's it for the lung cancer screening. Then, in our post, we embedded a tablet interactive decision aid, decision coaching module.

So what happens is the patient has the iPad in hand, and they have some patient-facing education talking about the benefits and harms. It's very fast and quick. Patient can get through it and two to three minutes, five minutes if they're not tech savvy. And then we have an advanced practice provider sort of talk about what do they know about the benefits of lung cancer screening? What did they know about the harms, and what are their primary reasons for wanting to be screened, just to kind of confirm their issue, confirm their decision to be screened.

And so what did you end up finding with the intervention?

What they found is that, one, with the decision coaching aspect of it, the advanced practice providers can deliver all the key elements that are required for the counseling and shared decision-making to defer CMS reimbursement. So I think that's really important, in the sense that so much of what we already see in the literature, providers talk a lot about the benefits of screening, but they don't note any potential harms. And it's really important to notice that screening is not without its downsides, and that with an abnormal finding, there is inherent risk. It's not like you're just getting a picture taken. There are steps that need to be followed afterwards.

And the other thing is that what we really like and what our clinical operations people appreciated is the fact that this embedding entire new process did not increase the throughput time for the time that the patient checks in to the time that that patient checks out. Because every institution is paying a lot of attention in money, as to what is throughput time and making sure that it's not too long. And from a patient's anecdotal evidence, the patients appreciated that additional process, because it broke up the time between the waiting periods in between each step.

Yeah. I think that's an incredibly important point that you point out, that they didn't really increase the visit time, but how did that work? The intervention took place during a time that they'd normally be waiting or doing something else?

That's basically what it is, because we did time-motion studies in the pre and in the post. So we followed patients from the time they checked into the time they checked out, and we cataloged what they were doing. And what we saw when we looked at that data in more granular level is that the time was shifted from waiting periods to active time.

That's great. That's really important that you were able to show that. I thought it was interesting that you commented in your paper about the different elements of the shared decision-making visit. That in fact, what we might think of as the primary reason for doing it, which was the element of reducing mortality or their chance of dying of lung cancer, was actually the least important part of the shared decision-making visit. Why do you think that was?

I don't know if it was the least important part. It's just that we had some slides dedicated to it for the decision coaching, but there are so many more harms to talk about, and it's also an artifact of the context to where this intervention took place. So we took it, we were dealing with patients who had already been scheduled to be screened. So we were just confirming their decision, and I think the advanced practice providers knew that. So they might have glossed over the benefit, because otherwise, the patients wouldn't be there, if they didn't value the screen.

Mm-hmm. I guess that makes sense. They knew why they were there. Is there a next planned follow-up study for this?

Good, I'm glad you asked that. So using this data, we're testing this more centralized model and using it in a different setting. So now, we're taking this into a quit line setting. So we have a Cancer Prevention Research Institute of Texas, or CPRIT, grant that's looking at the decision coaching being delivered by tobacco treatment specialists via phone.

So a primary care provider identifies patients with upcoming appointments that might be eligible based upon age and being a current smoker. And then they get contacted with our quit line folks, here at Anderson, and we deliver the counseling and share decision-making visit, in addition to the cessation, and we give a report back to the BCP. And well, we're hoping that increases individuals to get screened and also have proper follow up, if there is something abnormal on the scan.

So I'm curious if you have any other suggestions outside of your program of ways we might improve the uptake of lung cancer screening in the US.

Oh, I think we could do a number of things. So I think we have to think about each step of the pathway. Right? So one, we have to increase awareness of it. So that's through social media, social marketing, that kind of stuff for both patients and providers and caregivers.

Then, two, we need multiple avenues, where we talk about lung cancer screening, like how we do with breast cancer and colon cancer. Like at church, at your beauty parlor, at your grocery store, and have those kind of public health interventions to get out the information. And three, we really need to train up our health care workforce and help programs. Where it's possible to either have the PCP do it in a robust manner or have a more linked program, where they can refer to a centralized program. Where the counseling and shared decision-making visit can be delivered by their pulmonology or in the radiology scan, and the patient can get scanned that day.

So I think there's a lot of different questions and different delivery models that can be asked, and this is a great area to be working in right now. Because with the release of the Nelson study, it's even more exciting to show that lung cancer screening can be very beneficial, and with using the lung rads, the false positives are much lower. So I'm pretty excited, and I think there's so much opportunity, and we can learn so much from what we're doing in breast cancer and colorectal cancer screening.

No, I completely agree with you. I think it's very exciting that the Nelson study was finally just published, and so hopefully, this will overcome any residual skepticism about the benefits of lung cancer screening. And obviously, continuing to improve on the screening tools themselves, maybe using some kind of companion diagnostic, maybe blood or breath-related, that might improve the-- or using artificial intelligence to better tell benign from malignant nodules. Ways that you can reduce the false positive rates would be very helpful. Well, Dr. Lowenstein, thank you so much for joining me on the podcast today.

Thank you. It's a pleasure.

Until next time, thank you all for listening to this JCO Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts, Google Play, or wherever you listen. While you're there, be sure to subscribe, so you never miss an episode.

JCO OP's podcasts are just one of ASCO's many podcast programs. You can find all recordings at podcast.asco.org. The full text of the paper will be available online at ascopubs.org/journal/op, in February, 2020. This is Dr. Nate Pennell for JCO Oncology Practice signing off.

Read the article: https://ascopubs.org/doi/full/10.1200/OP.19.00325

TRANSCRIPT

[PIANO MUSIC PLAYING]

DR. PENNELL: Welcome to the latest Journal of Oncology Practice podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor for the JOP. Today, I'd like to talk about clinical trials, specifically the complex process that goes into opening a clinical trial and the surprising amount of time and individual steps that go into what might otherwise seem like a straightforward process. And while we all agree that trials are critically important for patient care and making scientific advances, as a clinical investigator, I can tell you that they can be quite a challenge to open and sometimes take a surprising amount of time and resources, which can be frustrating.

With me today to discuss this topic are Dr. Shaalan Beg, associate professor of medicine in the division of hematology and oncology at the University of Texas Southwestern Cancer Center, and Ms. Erin Williams, associate director of clinical research operations at the Simmons Comprehensive Cancer Center. We'll be discussing their paper, "Improving the Time to Activation of New Clinical Trials at an NCI-Designated Comprehensive Cancer Center," to be published in the November 2019 JOP.

Welcome, Shaalan and Erin, and thank you for joining me on the podcast.

DR. BEG: Thanks for having us.

DR. PENNELL: So can we start off by talking a little bit about what's involved in the clinical trial opening process and why this ends up being such an important issue that leads to projects, like what you describe in your paper?

DR. BEG: Yes. It's a pretty complicated process. And I think I say it a lot, like, how a bill becomes a law. So how does a trial protocol become an open clinical trial available to our patients? So when you have a document which embodies the principles for the clinical trial or the clinical trial protocol, you have a consent form that will be a patient-facing document that the patient sees, which summarizes, in layperson's terms, what the procedures will be for the study. And then these documents have to go through multiple steps of approval within individual institutions.

For example, the institution review board will look at the document in terms of risk management or risk assessment for the institution. Scientific committee will review the scientific integrity and see whether it suits the patients that that specific center is taking care of. And then, in parallel, you have a group of experts who want to see if that trial is something which they can feasibly execute. So hypothetically speaking, if a trial needs treadmill tests, do we have a treadmill to actually do that? So really the rudimentary, sometimes, feasibility questions.

And then, as the studies are becoming more complicated, some of these studies have biomarkers which we want to identify patients for, and we need to test patients before we can find the right patients for the clinical trial. So that entire process is becoming more and more complicated.

DR. PENNELL: That all sounds like it makes perfect sense, but I know a lot of our listeners might be surprised to learn that this entire process from beginning to end can take a long time-- sometimes six months or longer. What are the consequences to an institution of taking a long time to activate a trial?

MS. WILLIAMS: So this is Erin. Well, the consequences can mean our access to clinical trials, right? So it can also mean access for patients to the clinical trials. So both of those things. If we take too long to open the study and a lot of other centers around the country or around the world have a study open-- and specifically, there are a lot of trials that are open internationally, and sometimes it's easier to open trials internationally more quickly-- then our patients lose access to those trials as the spots for enrollment fill up and the study goes closer and closer to its enrollment target.

But in addition, sponsors, industry sponsors, pharmaceutical companies that are bringing trials to their cooperative groups in which we participate-- these are NCI-funded large-cluster groups for phase III clinical trials, we participate with those as well-- they're looking at how long it takes us, as an institution, to activate a new study. And if we start to take longer than most other institutions, they may not favor us for a particular trial to offer that trial to us.

DR. PENNELL: This is such an important process, and I think this is really going to resonate with lots of people who work at centers that open clinical trials. So why don't you take us through the process? So what exactly did you do there?

MS. WILLIAMS: So this is Erin again. We convened a group of stakeholders, along with a leader from our institution's Lean Six Sigma program, to really map out the process. So we convene about four or five hours of a day for everyone to come in. And it didn't just include cancer center stakeholders, but it included stakeholders from our sponsored programs administration office at the institution, our institutional review board, human research protections office, our hospital review committee. We really wanted to gather together all those people who touch the process in some way throughout the course of the time to activation.

And so really with Patrice's help, who is our Lean Six Sigma expert, she really kind of started the process out, and we did kind of what your traditional Lean Six Sigma mapping might look like-- use sticky notes and words on sticky notes, mapping out the process on the long board, and then ultimately creating what the map looks like. And I think what it did was allowed everyone who was in the room to really take a look at the process and how sequential everything came out to look.

One of the biggest impacts that we identified and that we highlighted in the paper is what you really saw was this gap between our scientific review committee submission and the IRB review, and then everything else in the process, because a lot of steps hung on IRB approval and didn't want to move forward, including hospital review, contract execution, things like that, until the IRB had given their stamp of approval, which of course is the review board for patient safety.

So what we tried to do is, immediately, you could kind of see this visible gap in-between the steps, and that really showed us that potentially aligning that scientific committee review with the IRB review and allowing that IRB approval to happen more quickly might trigger some of the other steps.

DR. PENNELL: One of the things that I found really interesting when you were talking about the various steps in the process was when you chose to start the clock, because I know that there is a lot of attention paid to how long it takes to open trials. And, you know, in my experience, I have heard that there are institutions that somewhat game their numbers by not starting their clock to opening until they've actually gotten a lot of steps already done before they do, say, a regulatory submission. And then it looks as though they're opening the trials quite quickly, but they may have already had the protocol for many months ahead of time, working on things ahead of this.

And you guys chose to start from the time you actually receive the regulatory packet and the protocol to start, which makes sense. I mean, that's really when, I think, you, as an investigator, would think the clock would start. But did you ever get any pushback from your leadership or others to starting that early?

DR. BEG: No. I think it's a matter of being consistent with how we report our numbers. Similar to you, we are an NCI-designated center. We report these to our advisory boards and to the NCI in regular intervals.

I think whenever we're measuring numbers and we set metrics for any target, we run the risk of people trying to cut corners and gaming the system to make the number look good. I think that's pretty well-documented in any industry. And our time-to-trial activation has become this shared quality metric across the cancer center, across the institution. And we were worried that it may start being that way, that folks are trying to, "well, should we take out the weekends, those aren't really work days, or how about the time the sponsor has the packet, or--," you know?

And I think, as humans, we all have tendencies to try and come up with ways to make our numbers look better. But the advantage of publishing this to a journal like the JOP with transparency on how we're measuring it, and, you know, I think we had faith that our audience would recognize when our time is-- when our time clock is starting. And there wasn't any pushback.

MS. WILLIAMS: I'll just add to that. The reason why I think it's so important to be transparent with these numbers is because-- being in an administrative role and an operational in a clinical research office for a long time, investigators who are bringing a trial forward for us to activate, the calendar has started as soon as they bring me a trial that they want to open. And if I tell them that a study only took 60 days to open, and their recollection is nothing near what I'm telling them my metric is, then they're not really going to trust what I'm telling them overall. And I think it's important that I recognize, and that we recognize as an operation, that what really matters is that once we get the study, we're starting the process.

It just makes the numbers more useful to you, internally. It makes it more useful to the outside companies or organizations that you're working with. And, you know, even the non-value added time that's not in your control can sometimes-- you can intervene in that. You could potentially escalate things if you haven't heard from a company in a certain period of time. So I completely agree. That makes perfect sense.

DR. PENNELL: So, well, why don't we dig into your results? So what did you find through the mapping process?

DR. BEG: I think one of the issues was how we can move some of the steps that happened in parallel or that happened sequentially to try and make them work in parallel. And like Erin mentioned earlier, just mapping out the process and having the different offices represented on campus that are a couple blocks away from each other really think about how they-- when they start their clocks and why they wait for specific milestones to start a review process was very helpful.

So one of the steps was to really move from a sequential process of scientific review followed by an institution review board review into a process where we move that in parallel to each other. And different centers have grappled with this question in different ways. The way we decided to address this, we didn't want the IRB to be bogged down by a study that wasn't scientifically valid, that may have concerns, or is not novel enough. But we have internal data that our scientific review committee-- and this is published data-- that our scientific review committee very rarely changes the design or the structure of an industry-sponsored clinical trial, for example.

So we decided that we would come up with a process where the IRB will physically review the study at a time after the scientific committee has reviewed the study. If the study is disproved, then it falls off the IRB's docket. But if it's approved, then they will be ready to review it. And we were able to shrink that time from scientific review to IRB quite significantly by modifying that process.

We talked about institutional studies, so studies that our own investigators are developing. Those studies do tend to get more criticism at the scientific review committee. Our committees review them much more closely and have much more impact on those. And we decided to move them forward on a case-by-case basis. So it really required some restructuring.

MS. WILLIAMS: One of the other things that we outlined in the paper, one of the other outcomes, was that our hospital review committee agreed to review the study in parallel with the IRB and in the PRMC review process and just hold their approval until those approvals had been received. And that happened. And if you looked at the individual time to getting that hospital review committee approval immediately following the intervention, it went down significantly.

As with anything, it takes consent kind of massaging and working with those groups. And some of the offices and the infrastructure around clinical trial changed subsequent after we had our time to activation. And so with any of that change, processes start over, people start looking at things over again, and they decide, well, wait, why are we reviewing this in parallel? Or these other groups of people need to be reviewing this in more detail.

Having said that, as those processes have changed, what we've heard and what we've experienced with those stakeholders in the institution is that their eye is always on the activation timeline. And that if we report to them, hey, this time to review committee approval has kind of gone back up, it's creeped back, and we really need to look at this again, you can see their immediate response is, oh, absolutely, we understand, these are kind of some shifts that we made, but let's get together, let's look at it, we really are hoping to push it back down.

DR. PENNELL: Well, I think that's a great point to point out, that this is not a one-time thing. And whatever changes you institute, you can't just do it once and then expect it to be a permanent change if you don't follow up and ensure that it's still working.

DR. BEG: One of the other things which came up when we were looking at our numbers was to figure out how to staff different positions. And there are some steps of the activation process that are very nuanced, really require special expertise. And an example for that is the coverage analysis evaluation, where a third party independent of the investigator's team decides whether every procedure or blood test or scan gets billed to insurance or is that something that gets billed to the study. So is it a research procedure or is it a standard of care procedure? And in oncology, where philosophically we view research as embedded within standard of care, that can be a pretty tricky determination to make.

So the people who do this come in with a really unique set of expertise from their clinical-- that have clinical expertise and research expertise. And one of the things we noticed was for positions like those and for positions other than that, it's really important to have redundancies in those positions, so if there is staff turnover of any kind, that that process can keep moving forward. Because those are steps that-- it's hard for a consultant to come in and fill in and those people don't really just hang out on campus for us to be able to tap their time and to start processing those studies.

So other than looking at our processes, it did come down to staffing those positions and making sure that we create some redundancies in those positions so that we're not completely dependent on, for example, one person for a task like that.

DR. PENNELL: And that is such an obvious issue that I think maybe a lot of people may be shocked to hear that institution's administrations don't always agree that you need more than one person to do a task. But again, this is really resonating with me personally, because we went through this same issue. And there are so many important things that for some reason there's always just one person who can do it. And if they're out for whatever reason, or they leave and there's staff turnover, things just grind completely to a halt. And so I think that that's a wonderful illustration that hopefully will be convincing.

Did all of this work end up making a difference in your time to opening trials?

MS. WILLIAMS: It is making a difference. We are seeing improvements in certain steps of the process. We've definitely seen an improvement in our time to both scientific committee review approval, our time to IRB approval. Our coverage analysis timeline has been very steady. Our time to activation for our national cooperative group studies has been very stable at around 90 to 100 days, since instituting just kind of these simple-- well, not so simple-- but since instituting this whole process.

Where we still have challenges is in our budgeting and contracting process. However, again, since we've got that institutional buy-in, it was actually our sponsored programs administration office contract director who approached me about two or three months ago and said, you know what, we really need to talk about the workflows between covered analysis, budget negotiation, and contract, because I see things kind of being an issue for us, as far as getting expedited approval and execution of contracts.

So we had another about 2 and 1/2 hour meeting just about a month ago to sit down and go through that workflow and identified, again, a couple of key places where we can bring previously sequential steps into a parallel-step process.

And so once again, I think the take-home of the exercise that we performed is that we have institutional stakeholders who aren't necessarily just waiting to hear from us to figure out how we can do better, but are coming to us and identifying timelines and being able to work together to continue to make those happen.

DR. PENNELL: And it sounds like this has worked very well for your institution. But you point out in your manuscript that a lot of the processes are so unique to individual institutions that it's hard to make blanket recommendations that apply everywhere. So what can other sites who are also worried about their time to activation take from your process?

DR. BEG: I think one message is to know what your internal process is. And I think a lot of folks who are listening to this podcast will admit that at their centers there's no one document that really maps out the entire process. So for us, the process of mapping out the trial activation process was probably the most transformative bit, the rest sort of just fell into place.

DR. PENNELL: Shaalan and Erin, thank you so much for joining me on the podcast today.

DR. BEG: Thank you very much.

MS. WILLIAMS: Thank you.

DR. PENNELL: Until next time, thank you for listening to this Journal of Oncology Practice podcast. If you enjoyed what you heard today, don't forget to give us a rating or a review on Apple Podcasts or wherever you listen. While you're there, be sure to subscribe so you never miss an episode.

JOP's podcasts are just one of ASCO's many podcasts programs. You can find all recordings at podcast.asco.org.

The full text of this paper will be available online at ascopubs.org/journal/jop in November 2019.

This is Dr. Nate Pennell for the Journal of Oncology Practice signing off.

[PIANO MUSIC PLAYING]

Article available online at Journal of Oncology Practice.

TRANSCRIPT

Support for Journal of Oncology Practice podcasts is provided in part by AstraZeneca, dedicated to advancing options and providing hope for people living with cancer. More information at astrazeneca.us.com.

[MUSIC PLAYING]

Welcome to the latest Journal of Oncology Practice podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all recordings, including this one, at podcast.asco.org.

My name is Dr. Nate Pennell, medical oncologist at the Cleveland Clinic and consultant editor at the JOP.

Medical care can be very expensive in the United States. And a diagnosis of cancer can be a huge shock, both physically, mentally and financially. Medical expenses don't just impact financial lives, but may also impact treatment outcomes, as even patients who are cured of their cancer may be left with a significant amount of debt.

One of the primary goals of the Affordable Care Act-- so-called Obamacare-- was to increase the number of citizens covered by health insurance, so that these financial burdens would be lessened. And we know that as the result of the Affordable Care Act, overall insurance coverage did increase. But how well did this work for patients with cancer specifically? And what impact has it had on financial burdens?

With me today to discuss these issues is Dr. Joel Segel, assistant professor of health policy and administration at the Penn State University. We'll be discussing his paper, Coverage, Financial Burden, and the Affordable Care Act for Cancer Patients, to be published in the October 2019 JOP. Welcome Dr. Segel. And thanks for joining me today.

Thank you for having me.

So can you start, for our audience, just by putting the general landscape into perspective for us. What are the financial burdens that cancer patients go through, especially those who are in lower incomes?

Sure. So there's certainly been a lot of evidence that cancer patients face, obviously, a number of medical care and health burdens, but also financial burdens. And in some cases, the financial burden can be pretty significant.

We also know that certain groups are probably disproportionately affected. So we know lower income, especially sort of racial and ethnic minorities, and especially some of the younger cancer patients can face significant financial burdens, but it also varies quite a bit. And so the evidence is certainly mixed in terms of how it's measured, how a financial burden is experienced by these different patients, but it can be as extreme that there is evidence that 2% to 3% can experience financial bankruptcy. So these can be pretty significant financial burdens.

And I guess the last thing would be there's probably two ways in which a patient can face a significant financial burden. So one is, and the one that we actually focus on most in our paper will be, the financial burden that results from medical care costs. We can also think about that, obviously, cancer can affect an individual's ability to work. So there can also be an additional financial burden if they're unable to work or they have to cut back on their hours, and that leads to a reduction in their income.

And is there evidence that patients' insurance status factors into their financial strain and burden?

Yes, there's certainly evidence that patients that have more comprehensive coverage, especially those that are higher income, that may help to mitigate much of the financial burden, whereas patients-- and that's one reason why younger patients sometimes have less comprehensive coverage. And they also may have less in savings and be less prepared to deal with some of the financial burdens.

And I think that makes perfect sense. And so what was in the Affordable Care Act that was designed to help patients deal with this?

The Affordable Care Act is an extensive law with a whole bunch of different features. I think there are several that are probably particularly relevant for cancer patients. So one is the one that's probably talked about a lot, which is the Medicaid Expansion. So initially, states were required to expand Medicaid. Due to a Supreme Court case, it became optional. So certain states decided to expand Medicaid, and that meant that they expanded who would be eligible. So primarily lower income adults, particularly ones without children, became eligible for Medicaid in certain states. So that's one piece.

I think the other one that's come up a lot, especially in a lot of the news stories, would be the restrictions on preexisting conditions. So certainly leading up to the Affordable Care Act, one major concern was that individuals, particularly-- cancer was one of the prominent examples would be if they had previously been diagnosed with cancer, they might have trouble either obtaining health insurance coverage or being renewed for health insurance coverage. So the Affordable Care Act made it so that regardless of what health care conditions an individual had, they were guaranteed renewability of the health insurance or the ability to purchase a health insurance plan.

And I think the last two general sections that might also affect cancer patients would be, one, they set up a number of state-based health insurance exchanges to allow individuals to purchase health insurance, and particularly for individuals who are buying individual plans and not through their employer, prior to the Affordable Care Act, especially for those with cancer, might have had difficulty purchasing a health insurance plan. So these state-based exchanges were an opportunity for individuals to purchase health insurance, and depending on their income with subsidies. So there were both subsidies for the premiums, or what an individual would pay each month for their health insurance plan, as well as cost-sharing subsidies. So for lower income individuals, they could become eligible for additional assistance to help cover some of their medical care costs.

And then, I guess, the last part would be that the Affordable Care Act placed limits on what an individual would have to pay out of pocket, both in terms of within a given year, and also, they got rid of some of the lifetime limits to health insurance.

OK. So it's obviously a complex law with a lot going on. But fundamentally, ultimately, the hope was that more people would be insured and that fewer people would suffer the consequences of having to pay for expensive medical care without having the insurance to help them with that.

So with that now put into perspective, take us through your study. How did you design this? And what were you hoping to look for?

So what we wanted to do was to take a look at, in particular, the non-elderly population who had been diagnosed with cancer. So what we did is we took a look at a large nationally representative data set, the Medical Expenditure Panel Survey, which follows a random sample of individuals across the United States for a period of two years. And within that, we then try to identify a non-elderly-- and by non-elderly, that'd be ages 18 to 64-- who had been previously diagnosed with cancer, or who, in the data, we could observe that they had some utilization for which there was a diagnosis of cancer.