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  1. Conversations on Cancer

Transcripts - Conversations on Cancer - Cancer Disparities in Appalachia

Luckson:

A famous songwriter whose charitable work expands the globe once says, "Where you live should not determine whether you live or die." The Appalachia region, which expands from New York all the way down south to Georgia, has higher mortality rates than the rest of the nation, and seven of the leading causes of death in the nation. Today we're going to focus on cancer, and our talk will align really well with the National Cancer Plan and President Biden Cancer Moonshot initiative. Basically, that goal is to eliminate inequities to reduce cancer deaths by half in 25 years. When we talk about disparities, we often talked about racial, ethnic, gender, even age disparities, but rarely do we ever talk about geographical differences, and that's what we are going to do today.

Welcome everyone. My name is Luckson. I'm a thoracic oncologist here at the FDA, and we will have the opportunity to meet our guests. But before I go any further, I would like to introduce the mastermind behind this entire series of conversation, Richard Pazdur.

Richard Pazdur:

Hi, I'm Dr. Richard Pazdur and I'm the director of the Oncology Center of FDA at the FDA. The Oncology Center of Excellence is about five years old and was started with the original Moonshot proposal and program at that time. And part of our approach, our mission, is really to have community outreach and look at not only scientific issues and clinical issues of oncology, but also social determinants of health. And therefore, we began this Conversation on Cancer series many years ago. Originally before the pandemic, it was meant to be an internal program for FDA employees, but with time and with the advent of the COVID Pandemic, it became apparent that we needed a greater outreach. So we decided to take Conversations on Cancer really to another level and have it as really a program for the entire nation to tune into.

Today we're going to talk about healthcare disparities in Appalachia. This was an interest of mine. I've been to West Virginia and have spoken to many people and understand the unique problems associated with healthcare in geographic underserved areas. And I thought this would be a very good segue into dealing with some of the other issues of healthcare disparities. The original title of this was going to be The Forgotten. And I deliberately chose that title because I thought this whole concept of geographic inequities was really put on the side and not really addressed since, as Luckson mentioned, must much of the emphasis has centered around racial and ethnic disparities, and I think it's important that we also consider other disparities that exist in the United States when it comes to equity and healthcare delivery. So I really welcome everybody here and hopefully we'll have a fun time and an educational time and a productive time in discussing healthcare inequities really in this geographically underserved area. I'll turn it back to you, Luckson.

Luckson:

Thank you, Rick. And so what I'm going to do now is going to allow everyone to introduce themself after your name is called. In order to keep things organized, I'm going to go by alphabetical order by your first name, so we will start off with Angela.

Angela Stanley:

Hi, my name's Angela Stanley. I'm from Cabell County, West Virginia, and a town named Milton.

Luckson:

I'm jumping the line a bit because of his name. Instead of William, he goes by Bill. Bill?

Bill Petros:

Hi, I'm Bill Petros. Good afternoon. My background's in pharmacy and I've been involved in designing and conducting clinical research studies for over 30 years, both at the federal government sponsored level and pharmaceutical companies sponsored trials. And I've done it here and at a couple tertiary urban centers, too.

Luckson:

Thanks, Bill. Let's move over to Hannah.

Hannah Hazard-Jenkins:

Hi, my name is Hannah Hazard-Jenkins. I am a breast surgical oncologist at WVU in Morgantown, West Virginia, and I am the director of the WVU Cancer Institute.

Luckson:

We'll move over now to Heather.

Heather Foster:

Hi, I'm Heather Foster. I'm from Parkersburg, West Virginia. I participated in a clinical trial for immunotherapy for triple negative breast cancer and I'm cancer free.

Luckson:

Welcome. Nicole?

Nicole Stout:

Hi, I'm Nicole Stout. I'm a research faculty at WVU Cancer Institute. I'm also the associate director of our survivorship program and I co-chair the Rural Health Working Group for the Alliance Clinical Trials Network.

Luckson:

Thanks, Nicole. Let's go over to Patty.

Patty Davis:

Good afternoon. I'm Patty Davis and I'm a resident of Hampshire County, of Romney, and I am a 24-year survivor of breast cancer.

Luckson:

Thanks, Patty-

Patty Davis:

I'm happy to be part of this.

Luckson:

Thanks Patty-

Patty Davis:

And happy to be part of [inaudible 00:07:45].

Luckson:

Let's go over to Stephenie.

Stephenie Kennedy-Rea:

Good afternoon. I'm Stephenie Kennedy-Rea. I am the Associate Center Director for Cancer Prevention and Control at the WVU Cancer Institute.

Luckson:

And then we're going to round off and go over to Tina.

Tina Bhatnagar:

Hi, my name is Tina Bhatnagar. I'm a hematologist and medical oncologist at WVU Cancer Institute Wheeling Hospital. And parenthetically, I'm never used to being called last because my first name starts with a B, so.

Luckson:

Well, there you go. Bill, you threw everything off. So just a couple quick housekeeping, first name basis from here on out, and please feel free to answer any question even if it wasn't addressed to you directly. Feel free to pose questions along the way. Rick is on, so I warned you guys, everything is fair game from here on out, but what we're going to do is start off first with our patients, and so we are going to go to Patty. Patty, my first question is to you, can you just briefly talk to us a little bit more about your experience with cancer and then tell us, how did you leverage your experience to help other Appalachians in the area and even further out?

Patty Davis:

Okay, thank you. I was diagnosed and all of a sudden it was like, where am I going to get treatment? There's no treatment near me. I will have to travel 45 miles to Winchester, Virginia, or I will have to travel 25 miles to Cumberland, Maryland. So traveling was an issue and finding a doctor, which state do I go to? So that within itself and transportation, am I going to be able to get off from work? Can I work? So many questions come into mind.

However, I was blessed. I had a good job at the time that allowed me to have the treatments and do anything that I needed to do to be able to come back, which started me into the thought, I'm going to be an advocate. I want to be an advocate until the day I die and I can continue to help others. With that being said, I was chair of the Hampshire County Cancer Coalition for several years and Mountains of Hope, which is part of the West Virginia Comp Cancer Control Coalition at WVU, followed by an honor to serve as chair of Mountains of Hope for several years and been a member for over 20 years.

This opened the door to network and learn about opportunities to bring back to my community, as well as to share with cancer patients. Also, I was an advocate state and federal advocate for ACS CAN, being able to go on the Hill and advocate for more money and anything that cancer patients and cancer opportunities. I was also chosen by Lance Armstrong as one of two people to go on the Hill and advocate for the Lance Armstrong Foundation, followed up with another meeting in Austin at the end. And also, I was chosen to go to the Susan G Komen International Meeting for it. And that was just incredible to meet the doctors and all of the people that were involved in the world with cancer.

Those were just a few of the opportunities and each and every survivor has this support. They have the opportunity to go out there and advocate for themselves, share their experiences. And Bonnie's Bus was another one that I want to just mention that is a mobile mammography in the state of West Virginia that goes out to, I think every state, every county in the state, which allows those people that have no transportation to get a mammography. [inaudible 00:12:16] the part of trying to travel and navigate through the larger hospitals. And that is also something that a lot of people don't like to do. We have a mobile that's called LUCAS, and that's for lung cancer, which is something that's prevalent, highly prevalent in West Virginia.

And I had an opportunity to go to C-CHANGE, which was at that time, the chair and co-chair was President Bush and the first lady, Barbara. And I was able to provide input for the National Cancer Control program. And with that, being able to stand in front and speak to all of the top people in the cancer world was quite an honor. And the last thing I'm going to add is I was blessed to be able to get the West Virginia Breast Cancer Awareness license plate, and I have number one on my vehicle.

Richard Pazdur:

Good.

Luckson:

Awesome. Thank you.

Patty Davis:

You know what a great way to help people remind their mother, their wife, their daughter, get a mammogram. It could save your life, because that's what saved my life was a mammogram.

Luckson:

Yeah. Thank you, Patty.

Patty Davis:

No problem.

Luckson:

Thank you for that information. Talking about transportation, you talk about all the work that you are doing. Heather, I'm going to come over to you. Can you talk a little about your experience and then how did you navigate participating in a clinical trial over there at West Virginia in Morgantown?

Heather Foster:

When I first noticed my lump was in March of 2020 when the whole world was shutting down; no doctors. And at that point, my husband had just lost his job. So we were both unemployed and it was a slow process officially getting the diagnosis, to get in, to find a doctor, to get the diagnosis. And then I got accepted into the clinical trial. So in June of 2020, the tumor was almost five and a half centimeters. And then I didn't start treatment until August 24th. Thankfully, I was in a clinical trial, which I know it was a double-blind clinical trial, but I know that I received it, because I'm still here.

At first it was really, really scary when you don't know which doctor to go to, don't know where to turn. And so we were lucky that we went to Morgantown, which is two hours from Parkersburg. When I first went into Ruby at WVU, they treated me like a rockstar, and I thought that that was because I was in the clinical trial while I was receiving that treatment. And I come to find out they didn't know. Everybody is treated that same way at WVU, as a rockstar, is my best way of describing it. So I was very thankful that we didn't have to go to Columbus or Cincinnati and that we were home, even though it is a two-hour trip.

It did get long. We did put a hundred thousand miles on a car within the past three years. But I'm very, very grateful that I had the opportunity to do so. I'm glad that I received that clinical trial, the opportunity that I had. I know that for me, at first, I wasn't sure if that is what we should do, but then I had nothing to lose. And it saved my life and I'll be eternally grateful.

Luckson:

Yeah, I know Heather, you described it as being, you got the golden ticket, you won the golden ticket.

Heather Foster:

I did, yeah. That's what, unfortunately, I went through... While I was going through a treatment, a friend of my mom's who, she's 18 years older than me, but she went metastatic and I was a couple steps ahead of her. Well, by two months in treatment. So while I was getting ready to finish up with, I'm sorry, radiation. So when I was finishing up with radiation, and had went metastatic. And at that point it was, it was very hard to watch her go through the final months knowing that I received the golden ticket. And as I said, the clinical trial saved my life.

Luckson:

Yeah. Thank you. Thank you for sharing that. Angela, let's go over there to you and talk to us about your experience. And even if there is one message you can consolidate, if that's possible, what would you tell your fellow Appalachian community and even outside, what is that message and sharing also your experience with cancer?

Angela Stanley:

Yes. I had my first mammo at the age of 35, and then every year after that. And in December 2004, I had a mammogram. Everything was great. But then from April 2005, they found out, I found out I had breast cancer. I feel that having the first mammo done and the yearly mammo done helped me find my cancer early. I found it myself by self-examination [inaudible 00:18:27], and I felt the lump and it was my right breast. My husband and I thought that maybe it was because I was right-handed, I was working out, and my muscle on that side was getting bigger than the left. But I come to find out, my gut was telling me, no, I need to go get checked. Ended up being a 2.3 centimeters. My cancer was aggressive and hormonal fed, which years ago would've been a death sentence because of the cells dividing and multiplying and all that stuff.

Like I said, if I hadn't gone to get the first mammo done, then I wouldn't have had a baseline to know that there was a problem. Early detection is the key to finding out if you have cancer before it becomes a major, major problems. The earlier that you catch the cancer, the better off you are going to be in regards to the treatment and your outcome.

During my cancer fight, I met a lot of people taking chemo. During that time, I had a little help with a man up upstairs to help me write poems. And I write these poems regarding different cancers. If I found out that anybody knows somebody that's going through cancer, I'll send them a card with one of my poems in it, depending on what type of cancer they're going through. And I just feel that this is the reason that I was put in this position.

I was put in this position to help other people because I'm a people helper. That's just me. So I'm blessed. I was blessed to only have a lumpectomy. My son was a senior in high school when this all happened. I wasn't ready to leave. I was only in my forties before. And I just feel like that this is the direction that God wanted me to go take. He wanted me to get cancer so I could help other people. And then now I'm in the American Cancer Society helping more people. And I just feel blessed that I'm still around. I'm blessed with a nice family, a good home, and I wish everybody in West Virginia would be able to get the same treatment.

We need more outlooks for that. We need more for them. Because we've got to take care of our own as West Virginians, and we've got to take care of everybody else, whether it be anybody from here to California, we're all one nation and we all need to take care of each other. And that's just the way I feel about it. And that's why I'm here working for the American Cancer Society as a volunteer, and that's why I send out these columns.

Luckson:

Yeah. One thing I consistently hear in all three of you is that you are here to serve others, to help others, and home is home. I think I recall one of you sharing how you had options, but you really wanted to stay home to receive your care. So we'll have you guys talk more. Let's kind of transition a little bit to some of the experts with boots on the ground in that West Virginia area. I'm going to start off with Stephenie. Stephenie, you get the hard question. So we know that they cancer mortality rate, there's a little bit of data, but we know that specifically in Central Appalachia where you are at, West Virginia, 32% difference in cancer mortality rate compared to the national average. Why, Stephenie? Why is there such a distinguished significant disparity there?

Stephenie Kennedy-Rea:

So it's a hard question and I'll attempt to dissect it a little bit. I do want to share some sad information that I found out on Friday. But for the first time, as we've seen declining cancer mortality rates in our state for the past several years, our data will come out in 2021 and 2022, we will have an increase in cancer mortality for the first time in years. So this conversation is even more timely than we thought last week. And I think that's where I want to start.

I want to start by talking about place because we know that the zip code where we live is as important as the D NA that we have in our cells in determining health outcomes. And when we're talking about a rural Appalachian state, we're talking about a state with low population density, and that presents many problems with access.

So access to care, transportation. We have a couple of our panelists talk about our survivors, talk about the difficulty with transportation and finding care close to home. We also know that we have, from the primary care side, we have 95% of our counties are designated as physician shortage areas. And so that limits access and time to screening and time to treatment. All of those things are complicated by our rurality and our geography.

Additionally, in West Virginia, so our biggest city is 50,000 people. So we have more people out a WVU football game on a Saturday afternoon than we have that live in our biggest city. So understanding small populations and how services are usually set up in larger centers, it makes a lot of our population have to travel. So 65% of our folks live in communities of less than 2,500, so people are having to travel around. In addition to geography, it's important to look at others levels of social vulnerability. So 17% of our population-

PART 1 OF 4 ENDS [00:24:04]

Stephenie Kennedy-Rea:

... levels of social vulnerability. So 17% of our population experiences poverty and many generations of persistent poverty are also here. So when we look around in those hills and hollers that we were talking about before, there's a high level of persistent poverty. And with that, comes the conditions that includes are poor access to nutritious food and clean water, poor infrastructure development, lower educational attainment, and a lack of access to basic healthcare, which I already mentioned. Hannah and I were talking earlier today about health insurance status. And in West Virginia, we were lucky that we were an early adopter of Medicaid expansion. We had a uninsured rate that was climbing towards 20%. It went down to 4% after Medicaid expansion. But over the last three years, we've been inching up and we're now sitting at an 8% uninsured rate. This doesn't take into account the number of people who are underinsured. And with a cancer diagnosis, comes very costly treatment.

And we know people that have $5,000 and $8,000 deductibles, and if they cross insurance plan years, then that sets them up to pay that out of pocket two times and not once. So we have to think about and consider the financial toxicity in a population that has high poverty level. In addition, our working poor, 40% of our households are considered asset limited, income constrained working households. So they have lots of competing priorities other than healthcare and access to clinical trials. Additionally, we have to look at our own behavioral risk factors. So in Appalachia and West Virginia, we have the highest rates of adult prevalence of smoking in the country. We have high rates of obesity. We don't particularly engage in sun safety. We have 10% lower vaccination rates for HPV and we have lack of access to genetic counselors. So all of those kinds of behaviors and things that we could do to improve our chances of preventing cancer are not there and are something that we are continually trying to address.

Finally, I think I'm going to stop soon, but I think it's important to understand that Appalachian culture is strong. This idea of storytelling is a way that we can reach people. Understanding that if we're going to build intervention programs, they have to be built not on the disparities that I just talked about, but on the strengths of the people and the strengths of the community. Taking into consideration things like a focus on family, the importance of community. The fact that individuals and individualism is important and that people here, and you heard this from our survivors, really have a love of place. So that care close to home matters and respect for people and building trust are key. If we don't build relationships, we're never going to reach folks. And I say this all the time, we can have the best science, the most wonderful clinical trials, great community-based interventions, but if we're unable to engage people, it does not matter. So I'll stop there and let my colleagues talk.

Luckson:

I'm going to bring Hannah. Hannah, come into this conversation. Earlier in the year in June, you guys received some funding towards getting the NCI designation, and part of that funding, if I understand correctly, was to help address some of the cancer disparities in that southern region of West Virginia. Talk to us the reach that you guys are trying to establish. I know you in the northern region of West Virginia, but what about the south where really the disparity just takes a whole nother level. Can you talk to a little bit more about some of the reach that you're going on there?

Hannah Hazard-Jenkins:

Thank you very much for the question. I think one of the motivations for reaching across the state, as you say, is the concept that was already talked about by our survivors, which is care closer to home. And a hundred thousand miles is a lot of miles over the course of treatment. And so you think about wear and tear on your car, you think about gas money, you think about loss of wages not only for the patient, but the family members that are bringing the patient to these visits. And so, when we think about how we can be impactful as an institution, it behooves us to really think through an alternate way of delivering healthcare. And that alternate way is flipping the model to some degree if we can so that we start bringing care to communities that would traditionally not have access to care.

So with the regionalization, we are placing cancer focused clinics, as well as infusion services across the state. And I'm particularly proud of that when we put them into some of our critical access hospitals, which means that we're putting them into small communities where people who aren't able to travel like that are still able to get care. And so as we move and reach across the state, you are 100% correct, the southern part of West Virginia does suffer from higher mortality rates, higher incident rates. And in some cases, the incident rate's stable, but the mortality rate is high. So you're also looking at not just increases in the cancer diagnoses, but then poor outcomes. And so in that part of the state, there is at times in some communities, a sense of fatalism.

So you have to completely change the mindset of the entire population. And so what we do is try to garner trust and support, make sure that what we say we're going to do, we actually do, which is the first step in trust. And then build radiation oncology and medical oncology both in community hospitals and in critical access hospitals to allow patients to get the care that they want to get. And in some cases, understand the care that they should be getting. And I think those are all extremely important.

Stephanie's point of financial toxicity is profoundly relevant. We use Bonnie's Bus and Lucas were mentioned, and that's part of that in initiative to think through how we can deliver care a little bit more efficiently to people. We started medicine with house calls and we morphed into ginormous conglomerate health systems and force people to come to places. And it's time for us to stop and think about the value and the utility of that always being the case, and to start thinking through how can we make house calls again in a different version.

And so programs like Bonnie's Bus, Lucas, which is quite literally a ginormous 18 wheeler that rolls down the small little roads and hollers of West Virginia with a three-quarter ton truck behind it, pulling a generator so that we can go to small little federally qualified health clinics and screen people. And these are people who would never get screened because they don't have a access to screening. And so it meets the mission of the Cancer Institute. It meets the mission of our university, which is a land grant... One of the first land grant universities in the country. And our acknowledgement of our role in creating an environment where people feel comfortable and safe and have access to healthcare.

Luckson:

Yeah, and we're going to talk more, Hannah, with you. Let me bring Tina and Bill. And so Angela kind of touched on this a little bit in regards to early prevention. Definitely, we talked about clinical trial, Heather winning the golden ticket. Tina, my question to you as an oncologist, what are some of the barriers when it comes to clinical trial participation for patients in the Appalachia region? And talk a little bit about engaging the community in order to have a participation of patients in clinical trials that is being offered.

Tina Bhatnagar:

Thank you very much for that question. So I think it's well-recognized that nationally just across the country, clinical trial enrollment is low. And a very small percentage of eligible patients, no matter where you live, actually enroll on study. It's even lower in this region for a number of reasons. So some of those... And those barriers are at all different levels starting from even before a cancer diagnosis has even made, people's overall awareness of what a clinical trial is and what it has to potentially offer. So a lot of patient attitudes towards clinical trials I think are potential barriers in the sense that, like I said, there's a knowledge gap about what they are. There's a perception out there that they're going to be used as guinea pigs or experimental therapy. Nobody really likes the sound of that. Sometimes even when you educate patients on what clinical trials are, if they're not accessible to you when they have to go to a center, that is far for them.

Clinical trials have a lot of eligibility criteria and a lot of requirements to be on study. And quite honestly, people cannot always afford to comply with those requirements, which I think sometimes is a barrier for enrollment. So those are just a couple of things. And then of course, patient family members as well I think have an important role because even if patients are willing to enroll on studies, sometimes their family members who they listen the most closely to will discourage them sometimes because of their understanding of clinical trials and their experiences with them. So I think that's just kind of scratching the surface on some of the barriers that I think limit clinical trial enrollment in this area. So access, understanding eligibility requirements that the requirements of the study, and sometimes it's just the eligibility criteria in and of themselves can be a problem because when you're designing a clinical trial, most people design them with the healthiest patients in mind.

And so if you happen to have patients who are generally unhealthy who have comorbid conditions that prevent them from enrolling, then they're not going to be able to participate in something that could potentially help them. So relaxing those criteria, trying to figure out ways to make the study assessment visits a little bit easier for patients either via telemedicine or clinical trial units that can potentially visit patients in their home are all things that can potentially alleviate that issue.

And then of course, even before the trial comes into the picture, there needs to be some overall education and awareness at the grass and roots level that talks about what clinical trials are and how they can potentially help people. And to try to overcome some of the misconceptions that people have about them. And reframing the purpose of clinical trials to be something that may not only help the patient, but could potentially help somebody else.

And that those extra study assessments are all for research purposes that could also directly help the patient or somebody else I think is really important in trying to get that information across. The other thing I usually tell patients, which is really impactful, is that clinical trials provide them with access to potential... To drugs that previously would not be available to them otherwise. And that everything that we currently have to use was originally only available on a clinical trial. And so that usually resonates with patients profoundly when they're trying to make that decision.

Luckson:

[inaudible 00:36:43], I'm going to bring you in to add on, and also I'm going to ask you why is it important to have patients in the rural setting be part of clinical trials?

Bill Petros:

So I think Tina did a great job in outlining a lot of the factors that are involved in individual patients, but oftentimes as scientists, we try to answer as many questions as possible with the fewest patients. And that oftentimes is a problem in a rural setting because we start to ask for... We have added objectives, secondary and other objectives to the trial that requires some biospecimens and in multiple different timeframes while they're getting treated. And then the processing of those is complex sometimes. Things that we add on, sometimes it seem easy like electronic surveys, if you don't have good internet access, that could be a problem. Or if you can't afford internet access or a phone to be able to... A smartphone, and that could be a problem. So sometimes the things we think we're adding to trials that make it easier aren't necessarily feasible for rural patients.

The other things that sometimes I've seen and added onto trials are extra radiologic scans that are paid for by the study of course, but that requires an extra day of travel for patients that are coming a long distance. And finally the consent forms. Every time you add things on, the consent form gets longer and longer. And so, I mean, it's probably common to have more than 10 pages for a consent form. And that's just for a rural patient, oftentimes very difficult to deal with. I think the second part of that question you asked me to add on to why is it important to do trials in rural setting?

And I think as Stephanie and others have alluded to, if we want to make the biggest impact on cancer in the country, we should start where its mortality is the worst. And essentially, Appalachia in some ways is ground zero for that. And I think one reason why it's scientifically important to include patients from those centers or from those areas because they have... We wanted to see how well this product or this intervention is going to work. And if it works in these more severe conditions where you might have a tobacco smoker, an obese patient or whatever, that is probably not going to work as well. If it works there, it's probably going to work everywhere.

Luckson:

Yeah, yeah. And Nicole, you've been so patient, I'm going to come to you, but I'm going to dig deeper with Bill and Tina and feel free to jump in of course if you want to. But so I'm giving you the proverbial magic wand that you can do whatever you want and it will happen tomorrow morning. What would be number one, two, and three to be specific? Because Tina, I remember talking to you, you told us how you'll get this protocol, the clinical trial, and it'll be like where... Realistic... Really? This will never fly here. What are two, three things tomorrow morning it will implement because you have the magic wand, what would those be?

Tina Bhatnagar:

I mean, this is a little bit of a pie in the sky thing and it totally compromises the integrity of every clinical trial everywhere. But I think the eligibility criteria for sure need to be just generally relaxed because some of them are... I mean, some of them really don't make a lick of difference when it comes to outcomes. And I think it allows you too, to have a more real world picture of how a specific intervention is going to influence an entire population. So magic wand item number one would be to make the eligibility criteria broader and less restrictive would be one of my magic wand things.

The second magic wand thing would be to have materials that make it very easy for patients to follow the flow of the clinical trial, because I think sometimes there's a lot of confusion over just what all they involve. I would try to simplify them as much as possible from the informed consent to the eligibility assessments, and then to all of the study assessments as well. So those are all... I took two of them. I can give you a third one, but I can also defer that to Bill.

Luckson:

Thank you. Bill.

Bill Petros:

Well, I mean, first and foremost, you cannot have participation without centers who treat those patients in the area. As [inaudible 00:41:11] said, locality is very important to rural patients. But I think getting back to optional research studies, I understand why we need to do these. Oftentimes they're not the primary objective of demonstrating if that drug or that treatment works. And focusing on making things as optional as possible, in addition to the eligibility issues like Tina discussed, I think would really increase the ability to deliver these in a rural setting.

Luckson:

Thank you. Rick, you-

Hannah Hazard-Jenkins:

Can I chime in since we're going to do pie in the sky?

Luckson:

Okay, pie in the sky, continue.

Hannah Hazard-Jenkins:

So I'll just one other, and maybe it dovetails off of everybody, but in Morgantown, we're able to offer lots of trials, but people don't live in Morgantown. And so, one of the things that would make trials more accessible is that we could decentralize some of the non-vital, non-essential components. So a lab draw in Rome County, West Virginia really isn't all that different than a lab draw in Morgantown, West Virginia. So why does somebody have to drive three hours to get their labs? It doesn't make any sense. And telemedicine isn't the answer to everything in rural counties and in rural locations.

So I think somebody could be thoughtful about what is really essential at larger centralized locations, that's fine. But the stuff that really doesn't have to be done at a major center really does... It should be optional, be done elsewhere. Because there are people that will refuse trial because they're not going to drive two hours to get their labs and a blood pressure check. I mean, it makes zero sense. So decentralizing some of the requirements I think would be really helpful. Now [inaudible 00:43:05]-

Richard Pazdur:

Let me jump right in here, but we have to get to Nicole, remember her. She's been out there and I want to bring her into the conversation, but we've heard all this obviously. And this is not unique to geographic areas, but throughout the country, and we started a project just this year called Project Pragmatica, and really it's meant to make clinical trials as simple as possible. Okay? So we said get away from all of these eligibility criteria, what will the doctor do here? Okay? And then all we're interested in really is the survival curve. So we don't want a lot of radiological studies that could be done, whatever the doctor wants done basically in this private practice. And all we really want is data randomization and date of demise if it's a terminally ill patient population, so to speak. So those are some of the simple ways we really want to encourage simpler trials.

And I can't agree with you more about how the eligibility criteria and the informed consent has gotten way out of hand. And I don't even know if patients are reading these to be honest with you. Because when I was in practice, most of the people said, "Doc, would you put your mother on this trial?" And that's when I'll go on the trial. I can't make heads and tails out of this 15 page document here. And here again, I think this builds to this area that we've been discussing is trust in the healthcare system, which is fundamental to the entire system. And is not unique obviously to Appalachia, but is also true in the inner cities and Indian reservations, in all underserved communities.

Luckson:

Yeah, absolutely. Go ahead Nicole.

Nicole Stout:

I'm going to jump in here because Yeah, jump in Nicole, because I'm jumping in As a part of the work that the Rural Health working group in the Alliance Network has done is created a rural checklist. We are working on getting that published. It's not popular among the journals we've socialized it with, but I will tell you, simplification of the trial and the criteria is critical. And so the message to trialists and to those that are developing throughout the life lifecycle of trial development, from concept development, as they move through these review processes, there needs to be consistent and constant feedback to remember barriers, right? One PET-CT versus four PET-CTs. Guess what? There's a lot of places to get PET-CTs in general, unless you're coming to Morgantown or to one of our primary centers. So just those types of concepts in general, local drug delivery. We saw a lot of the COVID related relaxation of some of the regulatory burden, allowing remote consent, allowing local drug delivery.

Those are things that should, as we hang on, could be huge benefit to rural populations, to enhancing not just eligibility, but getting folks involved in the trials. The other thing that I'll say is we're talking a lot about drug trials. Obviously, this is the FDA, but from my perspective in survivorship research, I'm trying to do trials with interventions that change behaviors. And if you want to talk about how difficult that is, we've had a lot of challenges with a population with relatively low health literacy. So handing them a very complex intervention, a big binder with all this information. And patients will very timidly say, "I don't read very well and neither does my wife, and this is going to be really hard for us." Handing them something like a pedometer to track their steps was like a fangled device that was really, how am I going to manage this?

It was stressful. And so when we talk about simplification, I think from a research scientists perspective, I think a pedometer is very simple, but I'm handing them something that's different, they've never seen before. They've got to figure out how to use it, how to interpret it, and get me the information. That's a lot. That's a lot of... And a big fat binder with information, that's a lot for patients. So thinking about different strategies that we can influence people to help to promote behavior change and enhance behavior change on these trials as simply as we can, meeting them where they're at in their local communities is critical.

And from the survivorship perspective, that's really what we're trying to do is find those supportive resources in their local communities. Because while people will travel to Morgantown for cancer treatment, if we say to them, we want you to come back and see our dietician, we want you to come back and see our rehabilitation professional, they're not so keen on repeated travel for those types of supportive care visits. So we're really looking now to Hannah's point of care closer to...

PART 2 OF 4 ENDS [00:48:04]

Nicole Stout:

... care visits. So we're really looking now to Hannah's point of care closer to home. It isn't just cancer care delivery, it's supportive care services. We have rehabilitation facilities across the state. We have mental health facilities, but those professionals do not have a knowledge base in oncology. So they have great skills and knowledge, but they don't know how to apply that in the context of cancer treatment related side effects and impairment. And so building that community capacity through community engagement, professional engagement and outreach is a critical piece of what I'm working on.

Richard Pazdur:

Could I ask a question? And this is for the UVW staff. As far as recruitment of medical staff to the university as well as to the peripheral areas, how difficult is it? Do you face barriers in having people move to West Virginia, basically? We constantly hear small rural hospitals are closing. They're not a proliferation viewed as a money center, so to speak. So how do you address this issue of really attracting talent to the state, both in terms of physician talent, surgical talent, as well as nursing talent, nurse practitioners, et cetera. Any problems with that?

Hannah Hazard-Jenkins:

Well, I'll take that because I feel like 50% or more of my job is that. It is tough to be very honest. I think once you get somebody to Morgantown and can see what is here and what is truthfully a very rapidly growing health system it becomes easier. The regional sites can be very difficult. Oftentimes it's newer trainees who generally have younger families. So it's not just what's my call schedule going to be like, but it's what are the educational resources for my children? Those kinds of things all play into those kinds of decisions. And so it can be difficult to recruit. Oftentimes if there's a foundation that's there, it's easier for people to come and see themselves in those scenarios and in those locations.

It is about the resources that support the entire program. So your point is well taken. I think a lot of our nurses are locals. So these are people that have gone to nursing school, have been dedicated to a profession that, let's be honest, it can be very emotionally taxing and it takes a very unique person and perspective to be able to come to work every day and find joy and fulfillment when you're taking care of oftentimes terminally ill patients. And so nurse practitioners tend to come from starting as a nurse and then you can even have an associate's, a bachelor's, and then the doctorate degree.

Surgeons? I can speak to that. As a surgeon, I don't consider myself a rural surgeon, but I am a surgeon that takes care of rural patients. And that is a unique difference. And a lot of these small rural communities, the general surgeons of old did ortho and vascular and general surgery and maybe even deliver babies.

Richard Pazdur:

That's like days of the past.

Hannah Hazard-Jenkins:

Right. But when they retire, you have to replace them with six people. It's very disconcerting for these communities. And so those do have challenges. We have a resident in our surgical program who was very clear from the beginning. He wants to go to rural West Virginia and he is. He's a phenomenal surgeon. He will be a tremendous asset to southern West Virginia. And it's a very unique person that understands what their purpose in life is that can be recruited into some of these rural locations.

Richard Pazdur:

Of the students that graduate the medical school, how many stay in West Virginia?

Hannah Hazard-Jenkins:

It's a good proportion. So interestingly, when I went to medical school here, there were, out of our whole class, there were four people that came from outside the state. So they were the four smartest people in the class because ... Interestingly, all of them became dermatologists. But at any rate, so now that population's different. So there aren't as many young people going into medicine. And so now we're probably 50/50 if not more out of state. And so when they stay, it's kind of a big win.

One perception is that if you can take somebody from rural West Virginia and educate them, they'll go back. And there are people that do go back, but there are challenges with that. So one of my general surgery resident colleagues was from a rural county called Doddridge County, swore she was going to go back. Turns out there aren't any hospitals, so it's very difficult to be a general surgeon in Doddridge County. So even though the intent going to medical school was to return home, something like that happens or, oh my goodness, this is what life is outside of super rural, I like it. And so I'm not going back.

Richard Pazdur:

Have the number-

Hannah Hazard-Jenkins:

When you get them into fellowship, they usually stay.

Richard Pazdur:

Okay. Have the number of hospitals in these rural areas decreased? Because I heard that kind of in the Corn Belt areas in Illinois, Iowa, and in those areas, wheat areas. Kind of more the Great Plains states that rural hospitals are decreasing in number. Is that true or can anybody comment on that?

Hannah Hazard-Jenkins:

I think there's an element of that. I don't know our total state numbers. I do know as a health system, one of the things that we are interested in is saving hospitals, which translates to saving communities. So the hospital that our resident is going to, when we took it over had one day cash on hand, and so that would've otherwise folded. And so what you've done by saving the hospital, you save the healthcare delivery there, expand it with subspecialty, but the biggest employer in that community is also the hospital. And so you're saving the community and the wherewithal for it. So there have been a couple hospitals the state has called and said, "Hey, by the way, you're going to save this one," and so you go save it. But I think in general there have been some closures, but I think we've been somewhat lucky in West Virginia and not having massive numbers.

Luckson:

Yeah. Nicole, I'm going to come back to you. I want to come back to you now actually. We really didn't unpack survivorship yet, so you're not getting away that easy. But talk to us a little bit about survivorship and the challenges in Appalachia. What are the unique features in that specific area compared to even other rural areas throughout the United States?

Nicole Stout:

Yeah, I appreciate you coming back to me. Thanks. I think first of all, we have to level set when we say survivorship, what we mean by that. And the NCI defines survivorship from the point of cancer diagnosis. So from the time somebody is diagnosed with cancer, we should be thinking about helping them with supportive services throughout the duration, not just at the end of care after they're, quote, unquote, "done." Because many people never finish treatment and individuals are always sometimes on temporizing therapies for years. So when we say survivorship, we're talking about people who are living with and beyond cancer is the way I like to characterize it.

So let's unpackage that, what does that mean? It means that when individuals go through cancer treatments, and I think any of our patients could testify to this, there are anticipated side effects. We fully expect side effects that will diminish their ability to function and participate in their daily activities. How much that influences an individual and to the degree which it influences them and when is what we don't really know. There's a different severity spectrum for every individual. And so we should be thinking about that though from the time they're diagnosed because we can project risk. I know an individual with higher stage cancer receives various types of additional treatments and is at a greater risk for functional decline. And so we should be measuring that and monitoring those individuals over the duration of time.

So when I came into WVU about four years ago, it was because there was a phenomenal study that was done called the Bridge Program, and they looked at individuals at the end of lung cancer treatment and said, how do we assess needs? How do we manage these needs so that we can help transition them to beyond cancer care? And what they found was that these patients had a significant level of needs that were unmet. The majority of individuals that I think the average was seven unmet needs. Those individuals then had difficulty returning for follow-up visits because they're traveling to come back and see the one rehabilitation oncology specialist that we have in the state, the two out of the four oncology dieticians that we have in the state. That's a challenge.

So we are identifying needs at the end of treatment, which also led to the question, are all of those needs associated with the treatment? What do they look like from the beginning? So we've now taken the approach, our Bridge Program, our survivorship program is designed to start at the point of diagnosis. We assess the level of participation and distress in all of our patients. We've implemented some EHR driven support to help us identify when needs arise so that we can manage them expeditiously and not wait until and be reactive when these needs are urgent or even emergent.

And so the Bridge Program now has transferred this approach of proactive prospective surveillance of our patients. So that's great within the four walls of our cancer center, but then we have to think about that handoff out to the communities. And this is where, again, it's different. I had a chance to work with folks in central Pennsylvania. Broadband is much more prevalent in central Pennsylvania. So talking about things like telemedicine, telerehabilitation, teleconsults with social work, we are challenged by that here in West Virginia. It's a different population, it's a different geography.

So what works in one rural area, rural is not a monolith. And so we can't think of it that way. So we really wanted to assess what are the things that our patients in West Virginia are struggling with. And so we did a needs assessment survey statewide, and we had a really nice response of almost 400 patients across the state. And we learned a lot about unmet needs, specifically physical and activities of daily living were the predominant needs that were not met. So being able to get out and go to the grocery store, being able to walk down to their mailbox, which is not maybe just the length of a hundred yard driveway, it may be a quarter mile to get their mail. So those types of activities were the most limited. Psychological problems were prevalent.

And what we learned in capturing that information about our patients around the state, back to Stephanie's point, place matters. It matters a lot. And we've talked about zip code and how important that is to predicting outcomes of health outcomes. What we learned though from our patients is, again, to go back to rural is not a monolith. We can't say that everything is problematic and driven by distance as a barrier to care. Traveled distance. That's one aspect. What we found was the patients who had the highest needs in our study were from the counties that had the highest levels of social vulnerability.

So the CDC Social Vulnerability Index tells us about poverty within a county. It tells us about education level within that county. It tells us about economics and income in the built environment in that area. So our patients who had the highest unmet needs tended to be from those more socially vulnerable areas. So if we're going to manage the disparities, we have to start at the community level. I think Stephanie said, we can't just build programs. We've got to really get into the communities and help to create the resources and help to create the programs that will connect patients in a community that has a better health standing and better social demographic standing.

Luckson:

Yeah. No, and so Angela, Heather, and Patty, coming back to you three in regards to this conversation of the community patient engagement. What are your thoughts on, I'm giving you that magic wand, you each the magic wand now. From a patient perspective, what needs to be done tomorrow morning to help mitigate this disparity and outcomes in your region where you live at right now?

Heather Foster:

I would say traveling from Parkersburg to Morgantown, yes, I was very blessed and honored to have that opportunity, but to be able to have just gone to Camden Clark, which is the WVU hospital now in Parkersburg, would've been ideal. And to receive that kind of care in Parkersburg that we received in Morgantown would be ideal. And it was excellent care from when I was in Morgantown, from physical therapy to surgery to the nurses. They're Appalachians and they treated you with dignity and respect and to be able to have that close to home would be ideal.

Luckson:

Thank you. So interesting because being from the inner city, my experience growing up was that the academic centers were right there. They were not too far, but accessing it and getting into the system was a whole nother conversation. So it's so interesting hearing this conversation with regards to rural and not being a monolithic, at least getting that point of physically, the buildings are not even there. I could see them, but I couldn't access them, insurance, blah, blah, blah, blah, blah. But it's a different issue. But in the end, the patient suffers. Because we almost have to bring the care to the people instead of having the people go to the care, as you said, Hannah. Angela, let me talk to you. What is this? What do we need to do to fix this issue? What are your thoughts there?

Angela Stanley:

I met a lot of people when I've spoken about chemo that a significant other just kind of left them. It's supposed to be through sickness and health, well, that didn't fly that way. I also had some people, like a man that lives across the street from me, he's going through his cancer fight. He was a veteran. Well, he had to go all the way to Kentucky to get his radiation every day, which I thought that was not good. Radiation's bad enough. You're zapped, you're tired, then have to drive all the way back from Kentucky just to get your treatment. Now, that was years ago. I'm sure by now they've got places there that the veterans can go to as well as the normal people here in West Virginia.

It's very important to be able to be home. I was blessed to get to stay home. Had thought about going to WVU, but I just didn't want to get my chemos there and not be with my family. Family and friends and positivity will help you through all this. You think you are having a bad day, then you see somebody else having a worst day. And that gets your mind off your little troubles and you help other people. So that's one thing that's very important to have.

Like you said, too much information could be bad, just as if not enough information could be bad. I just remember reading a book that they gave me about all the side effects, what might happen to this, what happened to that. Scared me to death. So when anybody ever asked me about that book, I said, "Don't read it because it would just depress you. You don't need that." But I think we need more help here in West Virginia. We need more communities to get active. There are so many hollers and places that people are at that we may not even know they exist. But yeah. But I'm grateful and happy to be living in West Virginia. I am an Army brat, we traveled all over the place and West Virginia became my home at the age of five. And I'll not go away from here.

Luckson:

Thank you, Angela. What about you, Patty? What are your thoughts on how we can kind of turn the ship a little bit from a patient perspective? I think you're muted, Patty. There you go.

Patty Davis:

Okay. There you go. Okay, thank you. One of my things, of course, is having been diagnosed 24 years ago and fast-forward into 2023, I found things along the way that I felt that really would help. Of course, the transportation, knowing what transportation is in your specific community that can help you get to where you need to go. That's a lot of the phone calls that I have gotten in the past. And I find that a support group, which I was able to start a support group in Hampshire County, is something that really helped a lot of the newly diagnosed patients that I have talked with. And I have a lot of one-on-one sit downs to talk to people. And actually, I just got a call this morning before we went live, "Can you help me?" And of course, yes, I will give you the information that I have.

So it's just so important to be able to get the information at the time of diagnosis with the concern. There again, when you take your questions with you to ask, that's a question. If you had that concern about transportation. "Well, I don't know how I'm going to get here." And then afterwards, after treatment is over, I've heard discussed, "Come back, clinical trials." It was great. I had the opportunity to be with my husband who has passed from COPD on a clinical trial at Johns Hopkins, which was just fabulous. So when I've had the question, "How about a clinical trial?" Well yes, I can talk about, I would do it in a heartbeat. I would do it in a heartbeat, and then I tell them why. So it makes them think different thoughts of, yes, if it doesn't help me, it will help someone else in the future.

Luckson:

I think part of the solution is having Patty, Angela, and Heather be cloned and have you guys go all over West Virginia and just have robots just talking. Go ahead, Angela.

Angela Stanley:

I'll go anywhere you want to go in West Virginia.

Nicole Stout:

But this really speaks to an important point that is a take-home here. Number one, these individuals that you're hearing from are really exceptional patients and they are advocates and they're willing to do this type of work. And there are probably many, many more of them. How do we find them? How do we tap into them to create these community engaged individuals that are trusted by that colleagues, their peers, their friends and family in their communities?

But the other thing I hear in this conversation is the unmet needs of patients is driving them to find someone like a Patty or Angela to say, help me. I need help. They need help because they're not either getting the information or the support or the resources from wherever they're getting treatment. So while I think, again, I think about that whole continuum, when they're within the four walls of our cancer center, how do we maximize the resources available to them? Everyone should talk to a social worker. There's never a time when someone should be, "How do I get there?" We should be addressing those needs upfront.

But thinking about that community continuum, how do we bottle up and spray around the Pattys and the Heathers and the Angelas so that we can really create that capacity in the communities? I think that's where using them as trusted community partners is critical to us developing good, strong, supportive services.

Richard Pazdur:

I think you brought up a very important word, and that's trust. You have to trust the person that you're getting the information from. And we've had conversations, in fact, conversations on cancer, dealing with medical distrust because that has occurred throughout this entire pandemic and has been in the area of cancer therapy since the 1960s, 1950s. Numerous drugs, Laetrile, inaudible 00:22:35], et cetera, that have been touted as cancer miracles, so to speak, and were fraudulent therapies basically. But it's important to have that trust. And trust generally comes from the community and your family, basically.

Patty Davis:

Well, I've found also with the community, I've had many opportunities in the past for small grants that are out there to bring this into the community, to pull the community together, and it's just been really amazing. I was able to have an oncologist from Winchester come and we had a breast cancer and a prostate cancer activity on the same evening. And it was amazing. When it came time to talk about one and talk about the other one, I said, "Is anybody uncomfortable? Do they want to leave the room?" Guys, go here, girls, go here. And it was, "No, we need to hear it all," which I thought was just fabulous. Here are the guys learning how to examine a breast, check for lumps, and then even on the other side with the guys. So ...

PART 3 OF 4 ENDS [01:12:04]

Patty Davis:

... and then even on the other side with the guys. These are things that's very important to come back to grassroots in a community, but it has to be somebody that is a leader, somebody that they trust. I've had people call. I had a call, "Do I need to do this? Is this something that's going to help somebody or is it a scam?" and I'll say, "No. It's good. I've had this experience, and this is why I say it's good." That's how you get people to come in to your community or let people into your community that can make a difference.

Luckson:

I'm going to go to Stephenie. I did see you on mute, Stephenie, but patient navigation, having authentic navigation is critical towards enrollment in clinical trial. We can talk about that. We're running out of time. We have only addressed half of the information, so I'll let Stephanie talk.

Stephenie Kennedy-Rea:

One of the things I was thinking about when all the conversation was happening, and I think that Ric actually brought it out, and that whole idea of finding key stakeholders in communities, trusted members of the community and engaging those folks because, if we're going to create an environment where clinical trial accrual actually goes up, we needed to invest in education and awareness prior to people needing treatment trials. Some of that is just general knowledge and engagement, but I think some of it is thinking about how do we offer prevention and early detection trials so we normalized trials before they need a big treatment trial.

I think this has been touched on, but I think the whole idea of decreasing the literacy level and complexity of informed consent is really important. Even if it's a nonclinical trial, so if I'm doing something out in the community, it's a five-page informed consent to just run a focus group. I mean people aren't interested in spending time and it's complicated. I think celebrating people in clinical trials, I mentioned storytelling earlier, but I think if we can find clinical trial champions in all of our centers and tell their stories, it would be a great way of normalizing enrollment in trials. We can have patient navigators who identify and trial nurses who identify people for our trials, but I think that there's a lot that needs to be done on the front-end before we or Tina and Hannah have to have that conversation with a patient.

Both LUCAS and Bonnie's bus were mentioned, but those are our mobile screening units. We offer those as a research platform. We do offer early detection trials other than the actual screening to patients. We've done a variety of them, and what we found is that people are interested in participating in those trials when they're brought to their community, when they're explained to them in language that they can understand. As a result, our clinical and translational science institute is going to launch a mobile clinical trials unit in spring of 2024.

Luckson:

Tina, you're on the front line. You're seeing the patients as the oncologist. Talk to us about the importance of patient engagement and provider engagement with the community when it comes to like, we talked a little bit about this, concept of this helicopter come in fly by night, we need clinical trial enrollment, and take a couple patients and take them off. That's like the wrong thing to do. Talk to us a little bit about your experience and your thoughts in regards to patient engagement, community engagement with the academic center or the provider.

Tina Bhatnagar:

Yeah, that's a great question. It's actually a hard question because we can't necessarily make people engage if they don't really want to. Getting a general sense of people's backgrounds, where they are, what their situation is, what their lives look like outside of their clinic appointment and what really motivates them to really want to participate in a clinical trial, I have a unique vantage point because I've been in this area for two years, but before coming here, I used to work largely at very big academic medical centers where I was the second opinion. I was the first line person and I would see people from this area in my former job. It was interesting because people from Appalachia would travel to where I was working. They really didn't want to. It was just that they felt like they didn't have the choice to do it.

Then something interesting happened. I moved here, and I have the same level of expertise. I'm a primarily a hematologist. I studied just a couple of things, but I had this focused expertise, and I would meet patients here who didn't necessarily believe what I was saying even though I've spent my entire life studying five diseases. They would then seek a second opinion at an academic medical center only to be told that I was doing the right thing here. The only thing that was wasted was time.

There was that trust issue. It all goes back to that issue. They weren't exactly sure that I could offer the same level of expertise, so it does involve a lot of time and education in order to support that level of engagement between physicians and patients. Obviously, when you have so many of them to see in a given day, time is of the essence, but using it wisely and using our support staff wisely I think can potentially help heighten awareness about the different resources that are available both locally and at academic medical centers.

Like I said, it all comes down to awareness. We have one clinical trial that's actually open here because Hannah and I are very committed to clinical trials and having them open at the regional sites. We have one lung cancer trial open here. We had four patients who were eligible to enroll on that study, and none of the four of them enrolled. Two of them didn't enroll because they didn't like the wait time. They would have to wait two weeks before they even found out whether or not they were eligible to participate. In the meanwhile, they could have started something standard, so there was that issue. The third person didn't enroll because his wife told him not to, and the fourth person didn't enroll because they were looking at the same trial at a different academic hospital.

These are the things that we encounter just on the boots-on-the-ground level here that I think, moving forward, we have to address in order to make sure that our patients are engaged with this particular region.

Richard Pazdur:

I have several questions for the clinical trial apparatus there. Do you have any difficulty in attracting clinical trials to come into West Virginia, or is it pretty universal that the industry would seek sites there, seek your university?

Tina Bhatnagar:

I can certainly defer to him. I can tell you my experience. I think there's a lot of interest in opening clinical trials here, and I have not had any trouble. Actually, there's been more interest than what I thought there would be. Just from my prior role, I have relationships with certain industries that followed me, and so they would say, "Well, we have this trial," and they're very interested in having a presence in the community because, for a lot of cancers, those patients are managed in the community. They're not managed in a tertiary care center, so the community is really where you want those trials to be accessible.

From my vantage point, it has not been a problem trying to find people to allow clinical trials to be open here. The barriers we've encountered are just some logistical things and also just patient awareness and the level of interest. Because we've talked about access, now the question becomes, fine, if we improve your access, are you going to go on the study?

Richard Pazdur:

Yeah. Well, one of the things that we talked about several years ago is drug companies and other sponsors paying for transportation and housing for patients. Obviously, there was this issue of coercion of, but this is not the case because this was reimbursement and this is exactly what is done at the NCI Clinical Center here in Bethesda. What's good for the goose is good for the gander, so to speak. If we're doing it in Bethesda, why can't you do it in West Virginia, so to speak? Would that help you think? Because I think a recurring theme has been travel, travel, travel, and again, if you got reimbursement for a clinical trial if you were going to go on it because there are more visits, et cetera, for travel plus housing in some situations, would that help you think? Do you think drug companies are amenable to that from your experience of bringing that up?

Tina Bhatnagar:

I think it would definitely help to answer your question, because that's a huge limitation for a lot of people especially with gas prices being what they are. I think that making that easier for people would definitely promote enrollment. I think, if spun the right way to the pharmaceutical companies, I can see them being interested in supporting that for eligible patients. I've seen it for other trials, so I think, if we're trying to enhance accrual from area, I think it would be a very attractive option.

Richard Pazdur:

Because we have this whole program, Project Diversity, and in the recent legislation, there's a plan for diversity programs being implemented for all of the clinical trials. Here, again, we have to emphasize, when we consider diversity, it's not only racial and ethnic diversity, but also geographic diversity if the companies would want to incorporate this more in a uniform thing.

I think that's something, Luckson, that we should take back home and have discussions about especially from this rural area because a consistent theme as I sit here is travel, travel, travel, geographic isolation, so to speak, and that could be addressed somewhat.

Hannah Hazard-Jenkins:

Could I ask Heather to comment a little bit and anybody else? I know Heather was in a trial. As a patient, what would your perception, I'm sure you wouldn't mind support for the 100,000 miles financially, but as a patient being approached with, hey, here's a trial we could reimburse, how does that-

Heather Foster:

Right. In order to offset the time, the commitment that you're going to make, as I said, for us, it was just everything fell into place that this was meant to be, but, yes, when you think back on the financial burden, will we be able to get caught up on the watch, so I'm going to be able to get caught up, but, yeah, it is a tough thing. To see it as some type of reimbursement would help.

Richard Pazdur:

As I said, that's not considered to coerce patients on going to trial. It's basically reimbursement for travel and stay and meals. That's what the government basically does at the clinical center, so I don't view this as coercion.

Nicole Stout:

I just want us to be clear we're not a clinical trials desert here. We are members of the-

Richard Pazdur:

Yeah. No. No. I'm just saying to improve the number of more clinical trials.

Nicole Stout:

We participate in many of the cooperative groups, so we have a number of trials open at any given time. I would say we struggle to recruit just as many individual institutions struggle to recruit. I see the numbers every month of recruitment for the trials. Some of them, it's a challenge broadly. We can share with you what we see here in Appalachia. I think, the travel, this is something we put into the rural checklist, consider travel, consider building in financial reimbursement for patients on these trials because I do think that is probably one of the biggest barriers that we repeatedly see in here.

Bill Petros:

Yeah. Yeah. I'll just add, I think we have about 60 to 80 trials open at any one particular time. Most of them are interventional. Most of them are pharma or cooperative groups. Some of the pharmas do pay for transportation for the research days. However, you have to think other things in consideration, too. The spouse has to come with them. They might have to take a day off work. You might have to have childcare. There's ancillary things. I think a stipend isn't an unreasonable thing to think about in the context of those either.

Luckson:

Yeah. No. This is good information and that we will take back with us and process through.

Stephenie, I started it all off with a tough question with you. Because you eloquently answered that question well, I'm just going to give you the mic, and you can share whatever you want that's been discussed or even haven't been discussed.

Stephenie Kennedy-Rea:

Well, I think we've hit a lot of topics today. I think that increasing the focus on trials, understanding the importance of community, finding community champions, creating patient champions for trials, trial enrollment, I think all of those things in addition to, I think, the nuts and bolts like increasing the possibility of stipends for patients, I think that's a great idea. I don't know. I mean, I've said a lot of things today. I think it's our jobs to think creatively and out of the box in order to solve this problem because it can't be just be business as usual because we're seeing that that's not helping us recruit patients.

Luckson:

Yeah, and I know, Patty, I think you were trying to say something earlier. I want to give you an opportunity to share whatever that was.

Patty Davis:

I don't recall what I was going to say.

Luckson:

No worries. Well, why don't I just go ahead and ask you right now, if there is one message you could consolidate and share to your fellow Appalachians and outside of Appalachia, what would that message be?

Patty Davis:

My message would be be your own advocate. Take questions with you. Get screened. Stay on schedule. If diagnosed, make sure you take someone with you because you cannot recall everything that you need to know. I would like to encourage you to still live fully. Fight the power with love, courage, faith and hope.

Luckson:

All right, Patty, come on now. What about Angela and Heather? What about you two? What would be your message?

Heather Foster:

Yeah. I'm big on early detection. No age is too young to start self-examinations, mammograms, to get them early and the clinical trial. There's options, the ability. What do we have to lose? I mean, I think it's just a great opportunity that I wish more people were made aware of, that there are options there, that the opportunity is there, and not to be afraid of it.

Luckson:

What about you, Angela?

Angela Stanley:

I would say early detection is very important. Well, Heather said, it's always best to take somebody. If somebody is getting ready to go get the answer, they've got cancer or not, it would be nice for you to ask them if it would be okay to go with them. You don't want to have that bad news. I mean, I was blessed my mother-in-law went with me, my mom went with me when I found out that I had cancer. My husband was a truck driver, he was like two states over, and I wasn't about to tell him that far away that, yeah, I've got breast cancer. I was blessed to have somebody with me when we get the bad news.

Early detection is the key. Heather, you're correct about that. Always stay positive. When you're going through cancer, I know you'll have your good days, your bad days and everything like that. You've got to stay positive because negativity feeds that monster, and you don't want that to grow.

Luckson:

Yeah, and I think this is part of Ric's thought with having these conversations is that we don't have to limit it to this in real time right now. Even when we get off, you can share this information with your friends, family especially in that area, that region. Hopefully, we can distribute this and have a lot of people look at this. Now, you guys put me in a pinch here. I have three minutes. I have Nicole, Bill, and Tina, Hannah. You four figure it out. At the end of the day, I'm giving you two minutes between the four of you all, final words before we head-

Richard Pazdur:

Make it short.

Luckson:

Quick. Quick.

Nicole Stout:

I'll jump on. I'll just say, just real quickly, I think it's important for people to understand, like what Tina said, nothing that we do right now isn't because of a clinical trial. The operations I'll do tomorrow are the direct result of interventional trials from the '80s, '70s, so people understanding that this is the basis and the fact that, if you look at studies, if you have outcome change differences, if you put people on trial, those get mitigated completely. The more we can do to give access, to have trust in trials, the greater our outcomes and the higher the quality of care that we deliver.

Bill Petros:

Okay. I'll quickly say that a way for improved access to enrollment of rural patients in clinical trials is to actually involve clinicians who practice in those areas to be investigators and so they'll be more in tune with the clinical and logistical concerns regarding the design of the trials, and we hope to increase that in Morgantown.

Nicole Stout:

I will say to patients and to anyone listening, make your needs known. There is nothing that you are going through in life during cancer that is not related to your cancer treatment. We want to know if it's financial problems, paying bills at home, if it's transportation. Patients don't sometimes think that that's related and shouldn't bother their cancer doctor with it. Patty made the comment be moving, be active. I think all of that, but it's also make your needs known and ask questions certainly about how you get the resources you need to manage the issues that you're facing.

Luckson:

For all the hard work you do there, I owe you at least 30 seconds. Go ahead.

Nicole Stout:

Hannah, go with the last word, our esteemed leader.

Luckson:

I think Tina is muted. Actually, the esteemed leader, too, also for the whole thing is Ric, so I'm going to let Ric end it off, but before I end off, thank you, panelists. Thank you, Project Community team. I'm just one face behind the entire team I'm happy to represent. Thank you, team. Then also, the FDA IT team, we would not have done this without you also. Thank you very much. I'm going to hand it off to Ric to close us out.

Richard Pazdur:

I just want to thank everybody for their stories and to give us a glimpse of what goes on in West Virginia. We really appreciate this visit with you all on this hot July afternoon. This is perhaps just the beginning of further conversations with you because we're very interested in this whole topic of diversity, and that includes geographic diversity also and understanding unique challenges associated with underserved communities. I'll leave it at that, and thank you, everyone.

Angela Stanley:

Thank you.

Luckson:

Thank you guys.

Bill Petros:

Much appreciated.

Richard Pazdur:

Bye-bye.

Luckson:

Bye.

Hannah Hazard-Jenkins:

Bye. Have a good day.

Heather Foster:

Bye. Thank you.

Richard Pazdur:

Bye-bye.

PART 4 OF 4 ENDS [01:33:30]

 
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