Clinical Trials: The Patient Perspective Part 1

Follow along with our transcript below.

Join us for Part 1 of this two-part series on Clinical Trials from the Patient Perspective.  We review some of the basics about clinical trials for people living with MBC and share personal stories from our co-hosts Lisa Laudico and Sheila McGlown.  The team was joined by podcast members, Jim Kremens and Sarah Mann, as we spoke with patient advocates Lianne Kraemer and Christine Hodgdon.   The team then had a series of conversations with Lisa’s oncology team, Dr. Neal Fischbach of Yale New Haven Health, Dr. Corrie Painter of Count Me In and the Broad Institute, bioethicist Jill Manning of Mass General Brigham and Kirstin Schneeman of Faster Cures and the Milken Institute.  We spend time discussing the current challenges with clinical trials with each of these experts and set the stage for Part 2 of this series when we will discuss solutions to make clinical trials better for people living with MBC. 

Part 2 of Clinical Trials from the Patient Perspective will be in your podcast feed on March 29, 2021. 

Want more about things Mentioned in this Episode?
MBC Alliance #HereAllYear focuses on Clinical Trials 101 in March. Read and hear more patient stories.
Learn more about Clinical Trials at Metastatic Trial Talk - Search for MBC Trials and follow them on Twitter @bctrials. You can also find clinical trial information at Christine Hodgdon’s Stormriders website.
Learn more about the Metastatic Breast Cancer Project at Count Me In and find out how to register.
MBC Connect - MBC Connect 2.0 is an interactive, web and mobile-friendly patient registry where you can share information about your MBC disease history, experiences, and quality of life – and now, get potential matches to clinical trials. Also available MBC Connect Español
Read new guidelines for clinical trial eligibility for brain metastasis. ASCO details several FDA changes here.
How is the pandemic reshaping healthcare - our guest Kristin Schneeman comments in The Post-Pandemic Life Sciences Landscape: How a crisis enabled innovation, collaboration and a new way forward from SmartBrief

Meet the Guests of this Episode

Lianne Kraemer

Lianne is on the MBC Alliance committee for The Breast Cancer Brain Metastasis Initiative (The Marina Kaplan Project).

Why the Women Most Likely to Die of Breast Cancer Have Gotten the Least Attention

Christine Hodgdon

Visit GRASP or follow on twitter. Christine is #HereAllYear talking about How Clinical Trials Can Treat Metastatic Breast Cancer.
Breast Cancer Survivor’s Journey from “What Did I Do Wrong” to “What Can I Do Now?”

Lisa Laudico

Lisa is #HereAllYear talking about Life with Metastatic Breast Cancer

Sheila McGlown

A Survivors Lens Website
Sheila is #HereAllYear talking about The Role Clinical Trials Can Play in Metastatic Breast Cancer Treatment Real Pink hosted Clinical Trials from a Patient Perspective with Sheila McGlown

Dr. Neal Fischbach

Assistant Professor of Clinical Medicine at Yale School of Medicine. Follow YaleMed on Twitter

Kristin Schneeman

Director of Faster Cures at Milken Institute. Follow Milken on Twitter

TRAIN -the Research Acceleration and Innovation Network

Jill Manning

Bioethicist and Assistant Director of the Mass General Brigham Institutional Review Board

Dr. Corrie Painter

Associate Director of Operations and Scientific Outreach for the Broad Cancer Program

Transcript

+ 00:00:00 - Introduction

Voicemail:

Hi, Lisa. It’s _ with Dr. _ office. And Dr. _ just asked me to give you a call and let you know that she reached out to _ at NYU and _ at Dana-Farber. And unfortunately there are no clinical trials available for you. Okay?

Lisa Laudico:

Well, that's not good news.

As the Our MBC Life podcast team began work on this episode about clinical trials, I had confirmed progression. I did a biopsy for biomarkers, a liquid biopsy, and then the hunt for a possible clinical trial was on. Suddenly the story became my own personal story. This is Our MBC Life and it's my life too.

From SHARE Cancer Support. This is season two of the Our MBC Life podcast dedicated to exploring life with metastatic breast cancer from the perspective of us, the people living with this disease and the experts who partner with us to help make our lives better. I'm Lisa Laudico, and this is episode two of our new season.

We're focused on clinical trials from the patient perspective for the next two episodes. And we got to speak with fascinating, dedicated professionals who work to make clinical trials better. And with courageous patient advocates who are tireless in their efforts to improve the treatment outcomes through clinical trials for all people living with MBC. So glad you're here since no one should face MBC alone.

+ 00:01:38 -What is a clinical trial?

Lisa Laudico:

In today's episode, I'm joined by Jim Kremens who usually is our sound designer and composer, but who's also a caregiver to his wife, who's living with NBC, and he spent a lot of time as the principal, researcher and advocate for another close friend who died from ALS.

Jim knows a thing or two about how he wishes clinical trials would work for patients. We're also joined by Sarah Mann, our senior intern, this season, who also helps us by asking the questions that need to be asked since sometimes we all get a little too close to the problem to see the larger picture.

Hey Jim. Hey Sarah.

Sarah Mann:

Hey!

Jim Kremens:

Howdy. So there's this myth about clinical trials as being the last resort? It's crazy that only 5% of adult cancer patients actually participate in a clinical trial.

Lisa Laudico:

I know it's, it's nuts. It's a crazy low number. And even worse than that is the statistic for cancer clinical trials from 2008 to 2018, only 3% of the participants were black, but black women are more likely to die of breast cancer than any other demographic.

Sarah Mann:

And our fellow co-host Sheila McGlown talks about this issue best in her recent interview with the NBC Alliance here all year campaign to help dispel myths of clinical trials.

Sheila McGlown:

Hi, my name is Sheila McGlown and I have been living with metastatic breast cancer for 11 years. I have her2+ positive ERPR, breast cancer. I found out December 2nd, 2009 while I was active duty military, that it has spread to my liver and ribs. With HER2 there are more ways to treat it. I've had four progressions and this is my sixth line of treatment. And right now I'm currently on a clinical trial. I've been on it since July of 2018. And this is why my platform has always been clinical trials and diversity in clinical trials.

And that we need for researchers, when they're thinking about clinical trials, to recruit more black women in clinical trials, because I'm living proof that they work. I believe in them. And I think it's top-notch research and I think it should be a standard of care for everyone, and especially for the black community.

And also when we think about clinical trials, we have to think about transportation and childcare. I spend close to nine to 12 hours. My days of treatment for the clinical trial, because they test everything. I get good care now, because I know that I'm helping further research, and hopefully I'm helping more women live longer with metastatic breast cancer.

Lisa Laudico:

So let's just take a moment to clarify a few things. First, clinical trials are just a type of medical research study that determines whether a drug or a medical device or a diagnostic tool is safe and or effective. So investigators then develop a protocol and then they recruit volunteers to test that protocol.

Jim Kremens:

Clinical trials can be done by government agencies, academic institutions, universities, hospitals, or drug companies. It takes a long time. On average, about seven years for a research study to go through the steps involved. First, the protocol needs approval from an organization's institutional review board, the IRB, and then the FDA gets involved. Some interventions and studies never make it out of the testing phase. Others complete all the testing but are never approved.

Lisa Laudico:

That's crazy.

Sarah Mann:

So clinical trials are categorized into four phases or types. And the first describes when the drug or intervention is being used by people for the first time. So this phase helps researchers determine the dose range that will be tolerated and what the side effects can be.

Jim Kremens:

Phase two is when they see if it actually works. They take a safe phase one drug or intervention and perform further tests on actual patients with the actual disease to be treated. It can also be performed to see if an existing approved drug on the market can be used for a different purpose.

Sarah Mann:

And phase three clinical trials are done as the final step to gain regulatory approval to market the drug. They include large cohorts of patients and sometimes compare the new protocol with the standard treatment, a placebo, or even both.

Phase four is sometimes called post-marketing surveillance since it happens after the drug is available and in use to the general public. This inquiry may include further examination of side effects, different formulations, dosages, durations of treatments and interactions of different medicines.

+ 00:06:28 - Lianne Kraemer's Story

Lisa Laudico:

So when should we, people living with MBC began looking at clinical trials? We decided to ask one of the best experts on this subject and could find Lianne Kraemer. Lianne is a patient advocate who has been living with metastatic breast cancer with brain Mets since 2016. So we wanted to ask her about how her cancer progressed, when should we start looking at clinical trials and how to make that decision.

Lianne Kraemer:

So early stage was 2014, but it feels like a lifetime ago. The minute I felt it, I was into a doctor. And I have a master's degree in science. Like I considered myself, somebody who knew stuff. And so I always, thought that if you were somebody who regularly checked your breasts, which I did, when they told me it was stage two, I was like, Whoa, Wait, Whoa, how's that possible? I was at already stage two and that was just the beginning of my learning curve about breast cancer, but yeah, it was already stage two and in my lymph nodes.

My first line of treatment was a clinical trial. And to this day, I am incredibly grateful for that oncologist because it was incredible. So I met with the oncologists in St. Louis, and things have changed a little bit. They're moving a little bit away from whole brain radiation right away, but still that's pretty much the standard of care when you have more than five lesions. And so she saw me and then I went straight down to radiation and then we were talking about getting the mapping set up. If you've ever had radiation, they do brain mapping.

So the radiation oncologist started talking about, whole brain radiation, and during that appointment, the phone rang, it was the oncologist that had just seen me. And she said, I think I have a clinical trial for you. Why don't you come up after you've talk about the mapping and let's talk about it. And I was, like I think a lot of people, very naive to clinical trials. I held a lot of the misconceptions that I think the average person holds that it was something that you used at the very end when there was legit, nothing left to use.

I thought it was something that was a lot more experimental than it actually is when you learn about where the data comes from. So I was very curious as to why I would trade away whole brain radiation, which the oncologist pretty much said he thought that they would wipe them all out for something that was completely unknown.

I had these tumors growing in my brain, why would I take the chance of letting them grow for this clinical trial? So when I got up there and I listened to her, explain, I still just really didn't understand it. So I said, I just need to take some time and talk through this with some people. I certainly talked through it with my uncle. I talked through it with my oncologist who had been treating me in early stage. And basically, I really learned, I got a schooling on what clinical trials were and I learned that, everything that is used in the metastatic space, what I would do drug wise eventually had all been a clinical trial at one point.

And actually the drugs that you take in a clinical trial are the latest research, advanced stuff you can get your hands on. And you know what my doctor ultimately said to me that really solidified it for is that, this drug, this trial could fill and you could not have access to this drug for the time compassionate use wouldn't exist, but you could not have access to this drug for another three years or so until it gets FDA approval.

Brain radiation will always be here. So not going anywhere. So after getting all those opinions where everybody felt like the data was good on it, it was a phase two trial. I believe. The data was good and I learned that I wasn't really, just a rat. I held all those misconceptions.

I was like, sign me up and at that point, I did do a lot of tests and different things. It really wasn't that complicated for me to understand, but I also have a science background, so I don't know how it feels to face it when you don't. I understood what they were talking about. I think the other thing that really matters a lot when you're doing a clinical trial is who's explaining it to you.

There's a clinical trial coordinator, who's basically by your side for the whole thing. And you get this packet that can be 30, 70 pages thick, but their job is to really break down what your responsibilities are gonna be before the trial, during the trial, and after the trial. And I think that matters a lot. Cause the person who sat me down for my first trial was phenomenal and made it very clear and easy to understand. I'd already made up my mind. I wanted to do it, but then understanding what my responsibilities were very easy.

Lisa Laudico:

I love that your oncologist at WashU that convinced you that this particular trial could be a good one for you in helping educate you on what clinical trials really are all about at that stage. I do know anecdotally that we have oncologists out there, sometimes they're in community centers, where they just shy away from anything to do with clinical trials that they stay with standard of care. And that you have to then go for your second opinion to a major cancer center to actually get access to clinical trials sometimes.

Lianne Kraemer:

And the problem with that is, is that if you're like me, which I think a lot of people are, you wouldn't go seeking a clinical trial is your first line of treatment. If the doctor says, this is what I should take. And I just wanted to treat it. I was scared. This is what the doctor said we do. This is what we have to do. I was like , get rid of them, do it. But I feel like, gosh, did I dodge a bullet because I've had lots of SRS targeted radiation, but no whole brain.

And I think it's 2% women who are diagnosed with brain mets are alive two years later, it's four and a half for me. So I think that mindset is having to change of they weren't really thinking back then about long-term survival with whole brain radiation, which now we know is changing, especially with the HER2 group who have great drugs now that work systemically in the brain, they can really live a long time.

So do we want to do something so detrimental to them as whole brain radiation? And I think about it all the time. If I had returned to my oncologist in Chicago, they didn't have that trial. I wouldn't have been offered that trial. It's all about where you are and, there's so many problems and complications with access to trials. And like I said, as a beginning patient, I would have never sought out a clinical trial. And you and I know you really need to do those in the beginning.

My third treatment was a clinical trial. Yeah. I, the more I did them, the more I realized, and then I realized that brain mets are not usually allowed in clinical trials. Clinical trials have inclusionary criteria, you gotta have this to participate and exclusionary criteria. And unfortunately, because brain metastasis has historically had such a poor survival, they were historically excluded from clinical trials.

And it's just within the last five years, even that they've started to allow people who had a history of brain metastasis participate. So now those who have a history, had something radiated, had something treated, are seeing more clinical trials available to them. But the case of a new compound, allowing for somebody with active and progressing brain metastasis to participate on a clinic next to nothing.

Lisa Laudico:

So often as you say, clinical trials are the last step and they shouldn't be the last step. But I'm curious, what are your go-to tools to try to solve this problem?

Lianne Kraemer:

From the very first appointment you have with your oncologist, you need to make it very clear what you are willing to do and not willing to do. So the closer you are to the beginning of your care, the more likely you are to get into a clinical trial. So setting expectation from the beginning with your oncologist and what you're wanting to do and willing to do, and how far you'll go and expenses time off from work and those sorts of things have a very detailed discussion with your oncologist.

I think that's number one. Also there are so many good websites out there that have clinical trials listed that you can certainly search yourself. But I think it goes back to your oncologists is if you set the precedent that's what you want to do, you also, every time you progress you say, what's out there for me as far as a clinical trial and him looking or her looking and yourself looking then it's I think a good team that way. Because certainly they're going to understand nuances of the clinical trial that you may not. But that's where I suggest starting.

Jim Kremens:

What Lianne says makes sense to me, it's still very challenging to know what is the exact right next thing to do. I have pretty solid science background and I can read through endless studies and think that maybe I've found a solution or a path forward, but I'm in no way equipped to know that I do with any kind of certainty.

+ 00:15:41 - Finding Tools

Jim Kremens:

For that you need an expert team that you can trust. And basically that means your oncologist, but even then they don't necessarily know with certainty, many oncologists encourage patients to get multiple opinions because there are always so many variables involved. And that's why leading institutions have tumor boards. Even so, I think it's really important for patients and advocates to actually wade in and do the research because knowing about the disease allows you to collaborate with your doctor.

Sarah Mann:

One of the things we wanted to look at was how someone new to metastatic breast cancer would figure out how to find clinical trials. Since all of us working on the pod have been engaged in this world for a while and so we know some of the tools already.

Jim Kremens:

Exactly. What is it like for the person newly diagnosed or someone who's experiencing their first progression? So we asked people with no previous knowledge of clinical trials or MBC see how easy it was to figure out.

Sarah Mann:

And what we found was that the metastatic trial search is one of the great tools that is found on breastcancertrials.org , the Metastatic Breast Cancer Alliance website, along with other nonprofit websites. Links to all these great resources can be found in our episode notes. And we will be going into more detail in part two of this episode.

Lisa Laudico:

We also asked Dr. Neil Fischbach, an oncologist practicing in Connecticut through Yale New Haven health, what his thoughts were on how patients can find appropriate clinical trials and when they should or should not do so.

Dr. Neil Fischbach:

Identifying a trial is a significant challenge. Finding out if you're actually a candidate for that trial is another challenge and then having some objective person to sort through with you, is this something I need to travel for? Is this compelling enough? Is this something that's interesting and valid for me as a person or as more intellectually interesting to the investigator who's running the trial. But probably doesn't make a big, practical, treatment difference. Having that very good relationship with your primary breast oncologist is the key. Because that person, he or she really should help you filter: these are high-impact really important, likely to help worth driving two hours once a week for or this is something which is very early unknown, unlikely to be major impact for you.

As well as the critically important, where are you in your cancer journey? And so if there is a standard of care treatment, liable to keep disease controlled on average for two years very gentle and pills, you may not feel compelled to be part of a clinical trial, where there are others who might feel, you know what I understand, that's a really valuable standard of care for me now, but I want more than, I want to be thinking about clinical trials now. And then at the other extreme, we run into situations sometimes are the conventional options are limited and unlikely to provide long-term disease control. And we're really looking for something novel or different.

Sometimes we get so focused on, I've got to be in a clinical trial now. What's to be able to just standard of care ho-hum chemo. I don't want to do that and sometimes we almost find us wishing that the very effective treatment that we're on, but it's not working so we can get onto immunotherapy trial . And sometimes you lose sight of the fact that chemo is around for a reason, it works really well. There will always be chemo. And what we're actually recognizing is chemo is a great immune stimulant that when a cancer cell has been damaged by chemotherapy, it becomes more immunogenic.

Chemo together with checkpoint inhibitor immune therapy works better than checkpoint inhibitor immune therapy alone. And there are chemotherapy drugs, like Capecitabine, which are very gentle. And so when do I recommend people go on chemotherapy or clinical trial? So I'm always thinking about what's an ideal trial at any phase of cancerous, let's take a highly effective standard of care therapy and combine it with something else that may be gentle, may work better when combined with chemo. And the same with anti-estrogen therapy was the same with the CDK 4/6 story. And now the CDK 2 anti-estrogen therapy, highly effective, tolerated let's layer, something on top of that.

And then, as someone living with cancer, you're not necessarily saying, okay, am I abandoning, what would be an effective treatment like chemo and going onto a complete unknown, and this kind of gets to at different phases of your cancer, you have different options. You're really in the driver's seat in early line breast cancer therapy. I want to pick the perfect trial that combines the standard of care treatment with a novel drug. I don't want to be in a placebo controlled trial, I'm going to throw all those out. Whereas towards a later line therapy, It may be more okay. I'm willing to participate in a trial where this drug may not be really well-known in humans but for me, it's important to be part of the process of moving the ball forward and expanding knowledge about breast cancer.

+ 00:20:55 - Lisa Laudico's Story

Sarah Mann:

So we know how difficult it can sometimes be to find and join a clinical trial. Lisa, you just recently went through this yourself.

Lisa Laudico:

Yeah. I had progression at the end of last year as noted at the top of this episode. So I have hormone positive breast cancer with mixed lobular and ductal characteristics.

And I'm considered relatively treatment naive in that during the three and a half years that I've been living with NBC, I've been on hormone therapy. Then I was on an immunotherapy trial where I progressed and they put me on another arm and another drug with the immunotherapy for just like a nanosecond before I then went on oral chemo or Capecitabine.

As Dr. Fischbach just mentioned, and it's also known as Xeloda, but this means that I've been on just four lines of treatment because of that progression on the immunotherapy trial. And that just put me out of the running for trials that would normally be a good fit for me. Because I had one too many treatments in my treatment history to be eligible. So it was just a surreal situation actually, where I've no known actionable mutations to access and the new treatments that aren't targeting, like certain actionable mutations. And so I found a trial in the end. And it was quite literally the only one.

So my situation is somewhat unique, but there was only one trial in the entire country that my oncology team and I felt made sense for me. And so I'm super grateful that I'm on this. I seem to be tolerating it okay. And we'll learn soon whether it's actually working, but not before the trial sponsors crazy rigidity actually made me wait to start the trial for at least a week, even though I'd been without treatment for almost a couple of months. So it was a wild intro to the trial.

You know, even my own oncologist was frustrated with the lack of flexibility demonstrated by the sponsors of so many trials. So here's my oncologist talking about allowing clinical trials to be administered decentrally within the cancer center system. Flexibility here equals less burden for the patient. Have a listen.

Lisa's Oncologist:

I think Covid has done this as well. And on one hand, having COVID allowed for a lot more flexibility. Allowing us to do this with the patients at the regionals? No. Why aren't we opening up in the one MSK regionals. We're not doing it because the company has decided they . Don't want it.

The pharmaceutical companies basically say, we won't allow you to open it up unless you only do it at MSK in the city. It won't be allowed for regionals. Okay.

Lisa Laudico:

And what's the reason for that?

Lisa's Oncologist:

Stupidity. We don't know if the pharmacy, if the research staff is up to par with regional. So it's basically suggesting that it's not one in this case, these are like rinky dink satellites , nothing to do with [unintelligible].

Lisa Laudico:

So all those thousands of patients that go to the regional MSK, I guess they should be worried and not go for their care there that's lifesaving.

Lisa's Oncologist:

We don't have clinical trials to offer them and they shouldn't be coming to us if we can't give them clinical trials. Un, fucking believable, right? I had a patient on a trial. It's a phase three clinical trial where it either get the trial drug, which has been FDA approved, negative versus dealer's choice.

She's getting this and to see she lives in New Jersey, all the way up to New York city every week to get her drug. Can we not give her this drug in the regionals, please? We're doing telemedicine, we're checking her bloods. It took six months, eight months to get that approved for us to be able to give it to her in the regionals.

No, really, really? This is an FDA F-ing approved drug. She's being followed by a physician. Who's seen her in the city also works then in New Jersey. And you're not going to make any leeway for he'll do it after she's been on the trial drug for a year, this is an FDA approved drug folks. Really? What is wrong with you? you know what I think it is, the sponsor is just overwhelmed with all kinds of requests and it's easier saying

No, no, no, no, yeah,

I am rigid. I am not interested in the wellbeing of people. I'm not going to wiggle at all. Then I'm sick. Then I didn't cross any lines. I didn't screw up. I didn't make any errors. I'm just going to say it to rigid as rigid can be, and then God will bless me.

Why, why wouldn't you make this for the ease of the patient?

+ 00:26:42 - Clinical Trial Challenges from the Patient Perspective (Exclusion Criteria, Diversity, Onerous Trial Design)

Lisa Laudico:

We know that all aspects of the clinical trial process are complicated from the initial inquiry, the funding needed the requirements for how they're designed the recruitment, the execution of the trials and various cancer centers and how patients actually engage with it. We've established that it is a difficult process. So let's take a moment to introduce the additional cast of experts we spoke to about all of these challenges.

To find out more about what think tanks and researchers think about how to make clinical trials more effective in the quest to cure all cancers, we spoke with Kristin Schneemann, the director of FasterCures, which is part of the Milken Institute. In this role, Kristin runs the train program, which stands for the research acceleration and innovation network.

We also spoke with bioethicist, Jill Manning, assistant director of the mass general Brigham institutional review board.

We spoke with Kristin Schneemann first asking her about inclusion and exclusion . Criteria for trials.

Kristin Schneeman:

I know this is an issue that you're very interested in yourself which is, there can be fairly rigid criteria about who's included and who's excluded. And then finally , once clinical trials are conducted the results of those trials, don't always hold true in real world conditions. And in part that goes to the inclusion, exclusion problem that we've tried to create such perfect experimental conditions in a clinical trial, around a product that, that it's not reflective in very many ways of what happens to the real people in the real world who will ultimately take that product.

And the, real world conditions that they're taking them in. There's just so many ways in which clinical trials are not serving the needs and interests of patients. We shouldn't be surprised that they don't always or very often even recruit very well. There many trials that never even get off the ground because they don't recruit adequate numbers of patients. So that's incredible loss potential, right there. Trials that never even managed to happen because of lack of recruitment or lack of retention of patients in trials.

Lisa Laudico:

And here's Jill with her thoughts.

Jill Manning:

I personally am not involved necessarily on the design of trials. We have the saying like you design we opine type deal. However, to get back to eligibility criteria, I think it's really important for people to know about these kinds of considerations. It is standard practice to have strict and rigid, if you say, inclusion and exclusion criteria for a high quality research protocol. And these criteria are always going to be guided by the scientific objectives of the study. And so when we're talking about exclusion criteria, we're talking about the features of individuals who may meet all of the inclusion criteria.

But they present these additional characteristics that could interfere with the success of the study, or they could lead to additional risk for an unfavorable outcome. And so they're always going to be developed with patient safety and sound research principles in mind. The most important thing is that we're talking about, from human protection side of things, which is where I work is always going to be the safety and the protection of those subjects. But we also need to keep in mind that having high quality research results and yielding that generalizable information is critical.

And when we don't have, standard and rigid or so exclusion criteria, this could lead the way for really unfortunate things to happen in data analysis, like selection bias, confounding, other random errors. And then that really skews the results and what our end goal here is to be able to have an intervention. And in this case, perhaps the study drug in which we can really confidently say that the desired outcome is truly associated with that intervention. And while I absolutely think that these screening requirements can feel daunting, overwhelming, and very upsetting and disappointing for many.

We need to honor that and keep talking about that, but it is helpful to keep in mind that they're in place for a good reason, and they're not designed to discourage participation. It all comes down to the science and you need to have that direct association with the study intervention, with the outcome. And when you have other medications involved there, it's very hard to draw a clear line to that outcome. And it's very frustrating.

Lisa Laudico:

Here's Dr. Fischbach confirming that in spite of all of this clinical trials should always be considered at every step for MBC patients.

Dr. Neil Fischbach:

I think that oncologists and clinical trial designers are trying to get better at basic entry criteria, more on a person's fitness and performance status rather than how many prior treatments they may have had, but yes, you still will find trials with ceilings for prior therapy or there's also a situation where you may elect the standard of care therapy. And there's a very attractive clinical trial open two months later, that's the standard of care therapy you are receiving, plus a very attractive novel agent. These are the kinds of things we weigh. And that's why I think it is always appropriate at any juncture and chair to be asking your doc is a clinical trial appropriate for me? What do you think? What's the standard of care available? What are we likely to achieve in that?

And sometimes that brings up uncomfortable discussions about how long do we anticipate that this next therapy you're recommending will last on average. And I know it's important to be hopeful but also very important to be realistic about these kinds of things getting tough, but really critical discussion.

Lisa Laudico:

And I think that speaks to the relationship between patient and oncologist and where that particular patient is in terms of understanding the trajectory of their own disease and how much information or decision-making they want in terms of that next treatment choice. And so every patient takes it a little bit differently, but I think it's that relationship between oncologist and patient, but also the understanding that there are these landmines that can happen, depending on how the clinical trial is designed.

Dr. Neil Fischbach:

Cancer is stressful enough, right? And so I think sometimes we overthink and I think when people are thinking about the clinical trial options and thinking about lines of therapy, am I going to make myself ineligible? I think that we can largely take that out, but that actually is fortunately a rare problem where people are not eligible for clinical trial that we wanted enroll in because the lines of therapy. It's important to think about, but practically is not often. So I just, I think at any decision-making juncture, we can decrease the stress level.

Lisa Laudico:

The example that I just mentioned of too many lines of treatment, therefore not being eligible for a trial that would have normally worked for the patient. It actually just happened to me. But it is illustrative because in speaking with my own oncologist and with the research trial nurses , they have a different approach. They go, we've had this challenge with this particular sponsor and it makes us so mad because they just want treatment naive people and I'm going but that's not the metastatic breast cancer community. We can't be treatment naive because we got to keep going and keep on taking new lines of treatment just to survive. And so they all said, yes, you're right, Lisa, we know it's nuts, but this is the way it is.

Dr. Neil Fischbach:

I also want to instill people who are participating in clinical trials with the thought that they are a exceptionally important altruistic valuable commodity. And it's only it's like being a college athlete, if you're going to be paid once you are due. Drug companies are going to make billions of dollars off drugs that they are developing for the benefit of people living with cancer. But as someone participating in trial, you should be like, you know what? I deserve a lot. I want a parking space. I want a meals. I want transportation, lodging. We at Yale are struggling with this because there's been a lot of concern about conflict of interest that you're paying people to participate in a clinical trial. If you're providing parking or these undue incentives that will influence people to participate and so for a long time, those kinds of services were actually they were rigorously weeded out of clinical trials. And now I think we're getting back to recognizing that no being a part of a clinical trial is incredibly generous and taxing and time consuming endeavor and people should have some benefits associated with that.

Lisa Laudico:

There's less than 5% of the adult population in the U S that are cancer patients are actually engaged in clinical trials. That's incredibly low. And then on top of that, you want to break down the differentiation of that 5% that actually participates in clinical trials. And so it does not at all reflect the metastatic breast cancer community. And so recruitment for clinical trials needs to include not compensation in terms, but taking care of every aspect of that patient's life that will be impacted by the trial. So childcare parking spots is, as you mentioned, a meal, perhaps accommodations, if they have to travel and all of that stuff, so I'm glad you mentioned it because it's an important component that clinical trials we're not just mice. We actually are humans with full lives there needs to be an accounting about that.

Dr. Neil Fischbach:

That is something which has really been increasingly recognized really over the last decade. So at Yale, for instance, like most major academic centers, this is a major emphasis of ours is identifying what are the obstacles to enrollment in a clinical trial, particularly what are the barriers for people of color, people who have less access to care. So one of the missions of Yale university medicine in general over the next decade is providing equal access to care for everybody. And just as you said providing childcare is not payment. That's a big obstacle for people being in a clinical trial. Transportation, the things that as you mentioned, roughly 90%, 94% of our trials are caucasian, generally more affluent where these are not issues. They're really critically important. So recognized hopefully to be better rectified over the near future.

Sarah Mann:

I love that Yale is taking a hard look at enrollment to clinical trials to make sure that unnecessary barriers are removed for people. We won't get a truly reflective pool for each and every clinical trial for the MBC community unless this is a priority at every single cancer center running trials We asked Jill what role IRBs can play in overseeing the issue of racial disparities in clinical trials.

Jill Manning:

It is a really big problem and it is a huge focus right now. I would say certainly the healthcare community, including researchers are waking up to it. But progress is slow. We've had over 300 years of systemic racism and I think that. Understanding and recognizing our history, which is not so distant and truly informs what our current landscape is. Cause there's a lot of valid reasons for hesitancy to take part in research studies. And this distrust is there for reasons and and I think that it's critical that we continue and expand and increase our education, not just to healthcare workers, but to researchers, all the way up from pre-med medical school to ongoing education at each institution and individual institutions have an obligation.

And we are certainly doing this as of looking back at our own histories. And what happened in your local context that may inform where the community is coming from.

I've done different works with building community resources and about how you can become an IRB member. You truly have a voice at the table for the approval of research and community members are an essential component of our review process. Also increased digital access across the board again from COVID we saw that this was a lot easier than people before and when we have increased digital access, we have increased access for all different members of our community. And it is so important that our research participants reflect the actual patient community of which we are serving.

Lisa Laudico:

So the question is Mass General Brigham actually putting some teeth to these new criteria that they've developed so that people are really truly being held accountable and that people in the community can then see, this is how we are holding ourselves accountable, because I think that's the next step in the gaining trust from members of different communities. We're going to do an audit on you, what would it look like?

Jill Manning:

I am seeing that initiative happen in real time in my own department, as far as who we're hiring for leadership opportunities and our cultivation of our membership base, and it is at the forefront of our minds and of our goals. This is the only way that things are going to get better is if we have IRB members who are reading these protocols , on consent processes and procedures, on eligibility criteria or the accessibility of a protocol or whatnot.

We absolutely need those voices at the table. And we are actively working with our division of diversity and inclusion as well as partnering with different individuals and communities to hopefully expand that. And I think then at a system wide level we need to ensure that our actual investigators reflect our patient population as well, that we are ensuring diversity in our hiring of postdocs. I do see real-time efforts at that. And I would hope that folks are thinking about it at the hiring level for individuals early in their career, so that we can keep all of that critical talent at our institutions for the prime years of their career.

Lisa Laudico:

What are the main pitfalls that you find that patients from the patient's perspective that the patients come up against in some of the clinical trials that you oversee.

Jill Manning:

One is that many of these clinical trials are only offered at academic medical centers in big cities and that excludes a lot of individuals who are living in rural areas. And while there's certainly have been efforts to establish satellite sites outside of these urban medical center areas we also have safety concerns with that because sometimes community hospitals or other sites aren't set up to be able to assist, should there be an adverse event

We also have barriers of non-English speakers and the consent process. The consent forms can often be 30 pages long and there are efforts to have translations and short forms and we are doing a lot better and COVID has taught us about the flexibility of interpreter services , which I really do hope it's translated across the board across all sorts of different research projects. But consent forums that are also a real barrier when they're 30 pages and dense

And then we also still have insurance issues. With cancer trials, specifically, insurance plays a lot more into it because corporate sponsors only pay for the true research procedures and they don't cover, an MRI, even if the if the individual needs the MRI for clinical care, the corporate sponsor is not going to be paying for that. So people still need to have adequate insurance coverage for participating in many trials. I think we see that less so in non cancer research.

Lisa Laudico:

You mentioned that so often the consent forms are very complicated medical language and that they need to be translated. They need to certainly make them a lot simpler, but also it's super helpful for the patient, considering the clinical trial to actually have a translator, like a nurse navigator. And usually it's a research trial nurse, depending on the cancer center , but at Mass General Brigham are they dedicating some staff to this effort of making sure that as many patients as possible who could be eligible for a clinical trial are given the kind of time and support for them to actually fully understand, not be so afraid of the clinical trial and, really take them through it in a more personal way.

Jill Manning:

I really hope that this is one of those lessons learned we can apply more broadly post pandemic. When we talk about consent, I always have , my tag, like we're not talking about a form. We're talking about a process. Consent is a process and consent is also a noun. It's not a verb. We do not consent patients. We ask for consent. Consent is something that is given from the individual to the investigators.

And we really need to honor and ensure that there is dignity around this process. This process involves a discussion not just shoving a 30 page consent form to someone and asking them to sign it.

Lisa Laudico:

There are many things that we'd want to have changed about clinical trial design, but we turn to Lianne for the patient perspective, specifically regarding brain Mets as an exclusionary criteria.

Lianne is there anything else on your list of things like, Hey, if I could wave a magic wand and make clinical trials more equitable and easier for patients, what would they be?

Lianne Kraemer:

Oh, God, I have a wishlist so long. That certainly is my number one wish because of how difficult it is to treat brain mets. For somebody who's listening, who isn't as experienced with brain mets, certain drugs that work in your body don't always work in your brain. You have to test out a drug. And so if you don't put it in trial and test it out, we won't know you could FDA approve a drug, but doctors won't be using it for the brain because it hasn't been proved. So we need to study everything in the brain. So that certainly is number one.

I think number two is to not be so restrictive on the Olympians of cancer being your participants in trial. And what I mean by that is don't pick the healthiest of the healthiest for your clinical trial because in reality and that goes back to those exclusionary criteria is if you've had more than so many drugs, you can't be in it. If you've had this drug, you can't be in it. And I understand that there's a balance and that they want to, they also don't want their drug not to be approved because they didn't pick the right people. But in reality, the user of your drug could look like the person you're excluding.

And so if you don't have a good balance in there of the people, who've had lots of treatments and people who've have this accompanying condition who have brain mets, you don't know how they're going to do so you're excluding people from your trial who are going to be users of your drug.

But certainly access and that more oncologists offered their patients. A lot of patients just never get offered clinical trials. If you don't go to a large center where there are clinical trials, if you aren't savvy yourself and understanding, I could be the perfect example, if I had not gone and not been where I was, I could have never landed on those trials. It shouldn't be dumb luck but it really was with me.

+ 00:46:11 - Challenges from the Clinician’s Perspective

Lisa Laudico:

Just last month, the American society of clinical oncology or ASCO and friends of cancer research, also known as friends, jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer, clinical trials, with the goal of making clinical trials, more accessible to patients, these recommendations as stakeholders to address five specific areas: treatment, washout periods , medications prior therapies, laboratory reference ranges, and test intervals and patient performance status. These recommendations were worked with stakeholders throughout the cancer research community and focused on expanding eligibility criteria to make trial populations more reflective of the general cancer population. Also to reduce clinical trial complexity, and to exclude patients from trials only where it is warranted due to safety concerns.

We also wanted to hear about the challenges of clinical trials from even more perspectives. Here's Dr. Fischbach

Dr. Neil Fischbach:

so I think that some of biggest things are largely as you alluded to clinical trials often insist on a very standardized population of people. And so are very exclusive and I wish we could sometimes broaden criteria for individual trials. I think that there are major deficits in identifying suitable candidates for clinical trials.

More and more clinical trials are being targeted to specific gene alterations in cancer or subsets of people with cancer. We're getting narrower in our ability to predict for who might a individual treatment work. And the drug manufacturer just wants that type of treatment. The days of having a CD 4/6 inhibitor, which may be broadly applicable to all women with ER, positive breast cancer, I'm not sure how much more of that there's going to be, and it's more going to be do you have a mutation in your RAS pathway?

Do you have a mutation one in a much less common gene that maybe 5% of people with metastatic breast cancer may have. And if you don't recognize that person immediately, you may miss that opportunity. And you also may simply have that trial open at your institution for months and months waiting for just that appropriate person to come, which costs a lot and takes up a lot of infrastructure resources. So, I think that matching people to their most appropriate clinical trial quickly will be important as well as being able to rapidly open and close clinical trials and institutions as appropriate candidates become available.

Lisa Laudico:

Here is Christine Hodgdon the founder of grasp and TheStormRiders.org. She's talking to us about the issues around recruitment and how it negatively impacts all of us.

Christine Hodgdon:

We hear doctors and researchers complain a lot about how they can't recruit. And that's very frustrating for patients because a lot of patients that I work with are like, and I don't mean this to sound glib , but dying to get on a trial. That's what they want.

We really want to get on a trial. So it is frustrating when we hear that. So I think the bigger overarching problem is decentralization. Another big barrier I think, is racism within the medical community. And I think that, until we address, I think there's like a hesitancy to address the racism in the medical community.

And as long as we keep denying that it's there, we're never going to actually solve that problem. We have two issues. Not only do we have to get just access for patients in general is important, but I do think this component of having access to a diverse community of patients is also a problem. We should really be looking at them in tandem and trying to address those problem in tandem. We just don't have a good way of communicating when a trial is available.

So there are tools, I think we could talk about MBC connect. That is a nice trial matching service and they use the breastcancertrials.org. And my website, basically both of those data is it's all combined in this app, and it's a really nice feature because you'll get notifications about trials that are opening up and you'll get notifications for ones that you're interested in, you can like favorite, which trials if you're trying to watch certain trials.

+ 00:51:19 - Challenges from the Clinician’s Perspective

Lisa Laudico:

You've mentioned, biomedical research has been a little bit behind say, even the research in, physics, for example. Why do you think that is other than you're dealing with human subjects, but is there something else going on that's causing this

Kristin Schneeman:

I, for myself, I'm not sure I have ever come to a more comprehensive answer then that it has a lot to do with the human race, the human element and the fact that this is research about human beings and the ethical concerns around that, which doesn't make it right necessarily. But I think that's where a lot of it proceeds from at least that I've been able to see. But I feel like there are other ways in which biomedical research has also liked behind other fields in areas like collaborative research.

Part of the reason I go back to physics is that my father-in-law was a physicist. And so I, a little bit of a window into that world through him. But again, for many years it's been extraordinarily common for, and it is more common now in biomedical research. But for, there to be these, just because of the scale of the thing and the expense of building some of the infrastructure they had to build and physics, I think they just had these massively collaborative projects and so much research is.

It's complex. It's multidisciplinary, but I feel like the field is slow to catch up to that. I think one challenge that the field is facing right now still is, data has become such an important element of all research, but I feel like in biomedical research, we still haven't entirely figured out how to integrate and give credit for contributions of data and data analysis in ways that maybe other fields have. Just, I can't entirely explain why this field lags behind some other scientific fields and doesn't pick up the lessons as quickly.

But in some sense, healthcare overall lags behind so many other industries, in so many respects in the way that we use or don't use data. How many times in the last year or two, have you had to fill out the same form , on paper, about your family health history and the lack of interoperability of the information systems and this whole business, this whole industry just habitually, lags behind so many respect.

Lisa Laudico:

Following up on what Kristin just spoke about. Here's Corrie Painter on the same issue. Corrie is the deputy director of Count Me In and a research scientist at the Brode Institute of MIT and Harvard. Not only is Corrie a trained cancer researcher with a PhD in biochemistry. She also was diagnosed in 2010 with breast angiosarcoma.

Corrie Painter:

Corrie brings a unique scientist and patient perspective here.

Number one, nobody has ever actually put the patient in the center of that question and said, what is everything we can do to help save that person's life? It just doesn't exist. That model does not exist from my researcher hat, what is everything I can do to get, make a discovery, to get my information in a high impact journal so that I can then get a better grant so that I can hire a postdoc so that we can get another good paper. It's just, the alignment is not focused exclusively on what can I do to help that patient live longer? It's not the, it's not that the researchers are bad. I am that very embodiment of that person who wanted to get the discovery to get the grant, as I'm sitting there with cancer, it's just the way the system has its incentives aligned. And so if you do not have incentives aligned with actually saving somebody's life, then you're not going to have the clarity of vision like you have in some of the other scientific enterprises.

You have these people that are getting sick and they're dying. And then you have people that are incrementally making career advancements or money, career advancement or money for themselves. You know what I mean? And I know that I know these people in their hearts, they want to help, and their hands are tied, but you have to have somebody to just shake that system. But I will tell you this, after being in this for 11 years now, as somebody who had cancer and is now researching it, I've had the unfortunate, ability to. Make friends with other people who have been in this field too, and then been diagnosed. Their entire perspective, changes every single one of them every single time, whether it's, Oh my God, I will never make another patient wait for a scan. I won't do that. I didn't know. Or, oh my God. I didn't realize that if I just was able to share my data with that other lab, we could get there faster.

Lisa Laudico:

Why is that medical research cancer research is still lagging behind the rest of information science it seems a silo is built based on archaic technology and information?

Corrie Painter:

It's ludicrous. And I am not sure to be honest, why we cannot seem to move the needle there, but there are these companies that are looking at this as a place to be disruptive. And they exist in the for-profit space to take somebody's data, that's their data and just make it more accessible to them. And so I'm not sure why, but I always try to follow the money, who stands to benefit from this remaining a silo? And I think it's the BMRs to be honest, if there's no incentive for them to change, by changing it means people can more freely share their data outside of that system. It's not in their best interest financially for them to knock down that silo. And if they have all of the power and the leverage, then the patient who needs it is not really, again, the concern. The concern is how do we make sure that we keep the data within our institute or within our EMR? That's my best guess.

Lisa Laudico:

Patients sometimes get stymied when they're doing their own research, if they have the capability to do because a lot of the research is hiding behind paywalls everything's in a silo. And, I know in the breast cancer research world, there's a project called the Aurora project where it democratizes a little bit, the tissue samples of a number of different patients who are part of that. And how do you solve that problem? That whole paywall issue?

Corrie Painter:

I think COVID proved even if you have bad stuff in pre-prints. I think the overwhelming majority of people don't want to see that go away. And so I don't think that's going to go away. don't know that we're quite there with respect to journals, just like not having any paywalls at this point. I don't know though, but I would love to see them go away as well. And so new models for how to keep the journals solvent, I think would be required before you could just be like, hey, I know you can't make any money, but we want access to everything anyway. So I think there needs to be a thoughtful process to make sure there was a model to make people be able to sustain their enterprises, but still have everything be open and sharable.

Kristin Schneeman:

Certainly don't have a solution available to that problem just yet. But I do you think that again, this is just to get back to the COVID experience? I think another aspect of that experience has been this kind of collision between the worlds of the academic journals and the preprint servers just as a sort of a shorthand and for people who don't know what preprint servers are they're really just essentially websites or online vehicles for sharing. Research results and sometimes data in a pre-publication forum. And so they haven't been these things, these publications typically haven't been peer reviewed.

They haven't appeared in a high. Falutin high-profile academic journal. But it's just a way of, for researchers to get their information out there a more quickly. So certainly in the COVID experience, this was happening all over the place that people wanted to have avenues to just get what they were learning out there faster for other people to look at and a way for the researchers to get some feedback from their peers before submitting something to a journal. So here's what we're finding, but maybe we'd like to have some other eyes on this. This is a phenomenon that has flourished in other areas of academia.

In other areas of the sciences, like physics, this has been a phenomenon for years and years and works quite well in those communities, but there's been a lot of resistance to it in the biomedical research field, I would say. I think some of that has to do with the fact that it's human it's research on human beings. Not only some of it's research on fruit flies, but there, there is always an element of well, but this is research about people. And so there's a certain level of ethical concern wrapped around all of it. I understand that. But I do feel like in the case of COVID there was a ton of stuff just coming out on preprint servers and even the academic journals a were showing themselves capable of turning around even, peer reviewed articles much, much faster than they typically do, but also they were starting to require articles that were submitted to post them on a preprint server before they would even put them through the peer review process.

So it was just this interesting sort of another one of those things that happened where you thought we have to seize this moment. Because this conversation has been happening for years, about how the journal publication business model needs to change. And that's, that gets to the paywall question because, the journals have been saying for decades that this is just the way it has to be. We have to support our operations.

We're, this work doesn't come for free. We have to getting these things peer reviewed is like the in process that requires investment and. Et cetera, et cetera, et cetera. We just, I feel like we've been stuck in that conversation for so long, but this year we really saw that open up and preprint servers are not the answer to everything we saw a lot of the side effect, that thing that comes with preprint servers is that a lot of information gets out in the public that maybe you shouldn't be out in the public yet.

There were results coming forward that were not ready for prime time. That's part of the point. You want other people to put their eyes on them, but. Given the high profile of the situation, news outlets would latch onto it and things would take on a life of their own. We saw some outright bad results making their way into the public. To, to me, that's all part of the process.

And part of that problem, which I'm sure you're familiar with is that there is no incentive for anyone to publish negative results. That's a whole other conversation is that often what we sometimes duplication of effort happens because nobody knew that experiment had already been done and wasn't successful because that doesn't, that isn't what gets you published in a high profile medical journal is saying I did this experiment and it didn't work out as I expected.

And I think technically if, particularly, if you're running a trial and it's NIH funded, you are supposed to report the results through clinicaltrials.gov. But that, it's not big. It's not reinforced.

Jill Manning:

If a sponsor wants to close a trial, they can just close the trial. And we might not always have the detailed information as to why. But they have internal data and safety monitoring boards to be evaluating the drugs, whether it's a safety concern or whether it's an efficacy, a futile efficacy the trial just stops.

As far as, understanding why a particular agent did not work. And how that might inform other scientists in that area. I think is a really important and thoughtful question. And I don't know the answer to that because we come up against these proprietary Issues all the time with confidentiality and sponsor privacy.

That's a plug for academic medicine because when it is, or individual investigators that are working in are affiliated with university, they are publishing on their own findings when they have negative findings. We see those in journals all the time. We do have that transparency on the academic medical side of things but again, we're talking about siloed situations, right? And the black veil behind corporates sponsors.

+ 01:02:47 - Why Hasn’t Cancer Been Cured

Lisa Laudico:

A cure for MBC will happen through clinical trials. So why hasn't breast cancer been cured? What issues do you think are in the way?

Corrie Painter:

I would say, breast cancer and almost all cancers suffer from the similar, phenomenon of being part of the human body. How do you eliminate some cells that are basically the same makeup with just a couple of differences from the other tissue in your body without destroying the rest of your body. And so it's just such a challenge to be able to target. And hone in on one aspect of who you are, because cancer is not an alien thing. It's not a virus that came in that doesn't belong there. It is literally part of you that is just out of control. And so how do you design something that is going to specifically only hit that part and not everything?

We're right at the beginning of how we can use our immune systems to help with this, but you need something that can adapt in real time to the situation. And I think it's just a matter of time before we unlock the potential for us to be able to treat these cold tumors or these tumors that don't have canonical features of things that are sensitive to immunotherapies. I think through combinations and through different ways of stimulating the immune system, we're going to get there. It's just going to take time for us to unravel it because it's such a complicated series of interactions.

Lisa Laudico:

It's maybe where we need to go. The what's in the way question of making that happen, I think that. It's happening, right? The research you're talking about that could really cure the cold tumors, the breast cancers, as opposed to the blood and the blood liquid cancers that are already doing really well, with this new direction of science, it's back to the what's in the way of medical research in general, right?

Corrie Painter:

It's also, we don't have the best model systems for the disease. We don't really have, you can cure cancer in a mouse. All day long. And it doesn't necessarily mean that same approach is going to work in a person or in a human. And we do a lot of preclinical work in order to get the hypothesis there in order to develop the clinical trials. And then we bring it to humans and it's not trivial to design and fund a clinical trial, it's just not trivial. And thinking more deeply about the preclinical space so that we can eliminate some of the cost and burden of trials that fail our patients, I think could also be an area that we think more deeply about.

+ 01:05:14 - Mental Health

Lisa Laudico:

So we ask all our guests, how they're coping with life during the pandemic, here are their answers to the questions, how they take care of their mental health.

Corrie Painter:

It's been hard for a long time, not just COVID times, I will say, just dealing with my own mortality because I'm never out of the woods with my own disease. And for example, I'm standing right now because I can't physically sit and I don't know if I've slipped a disc or if I have metastatic disease, that's how I live my life. And, the, only way that I've found that I can deal with that is to find a bunch of hobbies that keep me completely grounded in the moment at all times.

Lianne Kraemer:

Everybody is handling this so differently. So staying off social media has been my big thing because I was just started getting crazy, seeing some people, doing things that I don't even leave. Thanksgiving this year, I didn't go visit, see my family for the first time in my life. So it was really hard. Luckily my boyfriend has a great sense of humor and then he works really hard to make me laugh. So I'm really lucky.

Kristin Schneeman:

How have I been taking care of my mental health? I will say that it has been wonderful being in a job where at least I can feel like I'm in some way, making a contribution to helping solve some problems related to the pandemic. I am not researching vaccines, I am not delivering shots to people or groceries to people, or, doing things where I have my hands directly on it, but I do feel like I'm in a place where I can try to make some contribution to making the, all of this go away faster.

And then hopefully, keep some of the positive lessons and carry them forward. So that honestly has been good for my for my mental health. I take long drives with my teenage children and let them play their K-pop playlists for hours on end in the car. That's actually been really good for my mental health.

Lisa Laudico:

This podcast is produced by me, Lisa Laudico, and our truly amazing team of Bob DeVito, Dar Finkelstein, Natalia Green, Victoria Goldberg, Ellen Landsberger, Sheila McGlown, Reilly Starr and Anne Woodward. Our executive producer is Christine Benjamin, the senior director of patient services and education at share cancer support.

Our senior intern is Sarah Mann, along with interns, Angelica Alberstadt, Emily Lewis, Samantha Silverstein, and Amy Tedeschi. We've benefited from experts, social media consulting from Jake Amorelli and sound design and original music compositions from Jim Kremens.

You can find more episodes of Our MBC Life, wherever you get your podcasts. Be sure to subscribe and rate and review us and look for a new episode every second Monday, check out our blog, full episode notes on our website at ourmbclife.org. We would love to hear from you.

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