A Patient’s Perspective | Participating in a Clinical Trial

A Patient’s Perspective | Participating in a Clinical Trial from Patient Empowerment Network on Vimeo.

Colorectal cancer survivor Cindi Terwoord recounts her clinical trial experience and explains why she believes patients should consider trial participation.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.

See More from Clinical Trials 101

Related Resources:

A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?

Cindi Terwoord:        

Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”

And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.

Katherine Banwell:    

Mm-hmm. Had you had a colonoscopy before, or was that your first one?

Cindi Terwoord:        

No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.

Katherine Banwell:    

Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?

Cindi Terwoord:        

Well, I have a friend – it was very interesting.

He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.

And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.

And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”

Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”

Katherine Banwell:    

Mm-hmm. Did you have any hesitations?

Cindi Terwoord:        

Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.

Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.

I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.

Katherine Banwell:    

Oh, good for you.

Cindi Terwoord:        

I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.

Katherine Banwell:    

That’s a great idea.

Cindi Terwoord:        

Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.

Katherine Banwell:    

In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?

Cindi Terwoord:        

Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.

I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”

I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.

Katherine Banwell:    

Mm-hmm. So, how are you doing now, Cindi? How are you feeling?

Cindi Terwoord:        

Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –

Katherine Banwell:

Cindi, what advice do you have for patients who may be considering participating in a trial? 

Cindi Terwoord:

Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered. 

And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.  

And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.” 

But that was all very helpful, and I did get free parking for a few weeks. I mean, sometimes I’d have to remind them. I’d say, “It’s costing me more to park than to get treated.” But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it. 

Katherine Banwell:

Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with? 

Dr. Pauline Funchain:

First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.  

It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?  

 So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results. 

And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible. 

What Are the Risks and Benefits of Joining a Clinical Trial?

What Are the Risks and Benefits of Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.

Why should a cancer patient consider a clinical trial? Dr. Pauline Funchain of the Cleveland Clinic explains the advantages of clinical trial participation.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

See More from Clinical Trials 101

Related Resources:

You’ve Chosen to Participate In a Clinical Trial: What Are Next Steps?

Understanding Common Clinical Trial Terminology

How to Find A Clinical Trial That’s Right for You


Transcript:

Katherine Banwell:

Why would a cancer patient consider participating in a clinical trial? What are the benefits? 

Dr. Pauline Funchain:

So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.  

We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.  

I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.  

And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.  

Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial. 

Katherine Banwell:

Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them? 

Dr. Pauline Funchain:

Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.  

So, sort of getting all the subtleties of what those risks and benefits are, I think, are really important. 

Katherine Banwell:

Mm-hmm. What are some key questions that patients should ask? 

Dr. Pauline Funchain:

Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C. 

Benefits of Vitamins

Benefits of Vitamins from Patient Empowerment Network on Vimeo.

Vitamins are very important compounds that are required in small amounts in the diet to support various functions related to growth, reproduction, and the maintenance of health. Watch now.

See More from Rx for Community Wellness

Transcript:

Vitamins are essential micronutrients that are required for many bodily functions and therefore necessary to maintain health. Vitamins are traditionally categorized into two groups: water-soluble meaning they are dissolvable in water or fat-soluble meaning they are dissolvable in fat. 

Water soluble vitamins include a collection of B vitamins and vitamin C. Vitamin C is a powerful antioxidant found in citrus fruits like oranges and grapefruit and in cruciferous vegetables like broccoli and Brussels sprouts. The collection of B vitamins all assists in various metabolic processes in the body and are found in a variety of unprocessed plant-based foods and animal foods. Vitamin B12 is mainly found in animal foods but can be easily obtained through fortified cereals and non-dairy milks for those consuming a plant-based diet.

Fat soluble vitamins include Vitamins A, D, E and K. Vitamin A is an antioxidant and supports eye health found in leafy green vegetables like kale, orange and yellow vegetables like carrots. Vitamin D supports bone health and is obtained through exposing the skin to the sun, eating fatty fish and fortified foods. Vitamin E is an antioxidant that protects cell membranes and is found in nuts, seeds, fruits, and vegetables. Vitamin K supports blood clotting and bone health and is found in green leafy vegetables and Brussels sprouts.

Unless there is a deficiency, it is recommended to primarily focus on getting vitamins from food sources vs supplementation. By eating a variety of whole foods from all food groups, you can ensure that you are getting all the vitamins needed to maintain health, protect against cancer and support recovery from cancer treatment.

Thanks for joining this Patient Empowerment Network program. Please remember to ask your healthcare team what may be right for you.

Participating in a Clinical Trial: What You Need to Know

Participating in a Clinical Trial: What You Need to Know from Patient Empowerment Network on Vimeo.

 Are you considering participating in a clinical trial? In this webinar, Dr. Pauline Funchain, cancer expert and researcher, discusses what to expect when joining a clinical trial, including patient safety and questions to ask your healthcare about trial participation. Patient advocate and colorectal cancer survivor Cindi Terwoord shares her experience and advice for other people with cancer considering joining a clinical trial.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.
 
Cindi Terwoord is a colorectal cancer survivor and patient advocate. Learn more about Cindi, here.
 

Katherine Banwell:    

Hello, and welcome. I’m Katherine Banwell, your host for today’s program. When faced with a cancer diagnosis, could a clinical trial be your best treatment option? Today, we’re going to learn all about clinical trial participation, what’s involved, and how you can work with your healthcare team to decide whether a trial is right for you.

Before we get into the discussion, please remember that this program is not a substitute for seeking medical advice. Please refer to your healthcare team about what might be best for you. All right let’s meet our guest today. Joining me is Dr. Pauline Funchain.

Dr. Funchain, welcome, would you please introduce yourself?

Dr. Pauline Funchain:      

Sure. Thank you for the invitation. So, I’m Pauline Funchain, I am a medical oncologist at the Cleveland Clinic. My specialty is melanoma and skin cancers. I also lead our genomics program here at Taussig Cancer Center.

Katherine Banwell:    

Excellent. Thank you so much for joining us today.

Dr. Pauline Funchain:       

Thank you.

Katherine Banwell:    

And here to share the patient perspective is Cindi, who is a colorectal cancer survivor. Cindi, we’re so pleased to have you with us today.

Cindi Terwoord:        

Thank you, nice to be here.

Katherine Banwell:    

Before we learn more about Cindi’s experience, I’d like to start with a basic question for you, Dr. Funchain. Why would a cancer patient consider participating in a clinical trial? What are the benefits?

Dr. Pauline Funchain:        

So, I mean, the number one benefit, I think, for everyone, including the cancer patient, is really clinical trials help us help the patient, and help us help future patients, really.

We learn more about what good practices are in the future, what better drugs there are for us, what better regimens there are for us, by doing these trials. And ideally, everyone would participate in a trial, but it’s a very personal decision, so we weigh all the risks and benefits. I think that is the main reason.

I think a couple of other good reasons to consider a trial would be the chance to see a drug that a person might not otherwise have access to. So, a lot of the drugs in clinical trials are brand new, or the way they’re sequenced are brand new. And so, this is a chance to be able to have a body, or a cancer, see something else that wouldn’t otherwise be available.

And I think the last thing – and this is sort of the thing we don’t talk about as much – but really, because clinical trials are designed to be as safe as possible, and because they are new procedures, there’s a lot of safety protocols that are involved with them, which means a lot of eyes are on somebody going through a clinical trial.

Which actually to me means a little bit sort of more love and care from a lot more people. It’s not that the standard of care – there’s plenty of love and care and plenty of people, but this doubles or triples the amount of eyes on a person going through a trial.

Katherine Banwell:    

Yeah. When it comes to having a conversation with their doctor, how can a patient best weigh the risks and benefits to determine whether a trial is right for them?

Dr. Pauline Funchain:       

Right. So, I think that’s a very personal decision, and that’s something that a person with cancer would be talking to their physician about very carefully to really understand what the risks are for them, what the benefits are for them. Because for everybody, risks and benefits are totally different. So, I think it’s really important to sort of understand the general concept. It’s a new drug, we don’t always know whether it will or will not work. And there tend to be more visits, just because people are under more surveillance in a trial.

So, sort of getting all the subtilties of what those risks and benefits are, I think, are really important.

Katherine Banwell:    

Mm-hmm. What are some key questions that patients should ask?

Dr. Pauline Funchain:      

Well, I think the first question that any patient should ask is, “Is there a trial for me?” I think that every patient needs to know is that an option. It isn’t an option for everyone. And if it is, I think it’s – everybody wants that Plan A, B, and C, right? You want to know what your Plan A, B, and C are. If one of them includes a trial, and what the order might be for the particular person, in terms of whether a trial is Plan A, B, or C.

Katherine Banwell:    

Mm-hmm. Let’s learn more about Cindi’s story. Cindi, you were diagnosed with stage IV colorectal cancer, and decided to participate in a clinic trial. Can you tell us about what it was like when you were diagnosed?

Cindi Terwoord:        

Yeah. That was in September of 2019, and I had had some problems; bloody diarrhea one evening, and then the next morning the same thing. So, I called my husband at work, I said, “Things aren’t looking right. I think I’d better go to the emergency room.”

And so, we went there, they took blood work – so I think they knew something was going on – and said, “We’re going to keep you for observation.” So, then I knew it must’ve been something bad. And so, two days later, then I had a colonoscopy, and that’s when they found the tumor, and so that was the beginning of my journey.

Katherine Banwell:    

Mm-hmm. Had you had a colonoscopy before, or was that your first one?

Cindi Terwoord:        

No, I had screenings, I would get screenings. I had heard a lot of bad things about colonoscopies, and complications and that, so I was always very leery of doing that. Shame on me. I go for my other screenings, but I didn’t like to do that one. I have those down pat now, I’m very good at those.

Katherine Banwell:    

Yeah, I’m sure you do. So, Cindi, what helped guide your decision to join a clinical trial?

Cindi Terwoord:        

Well, I have a friend – it was very interesting.

He was probably one of the first people we told, because he had all sorts of cancer, and he was, I believe, one of the first patients in the nation to take part in this trial. It’s nivolumab (Opdivo), and he’s been on it for about seven years. And he had had various cancers would crop up, but it was keeping him alive.

And so, frankly, I didn’t know I was going to have the option of a trial, but he told me run straight to Cleveland Clinic, it’s one of the best hospitals. So, I took his advice. And the first day the doctor walked in, and then all these people walked in, and I’m like, “Why do I have so many people in here?” Not just a doctor and a nurse. There was like a whole – this is interesting.

And so, then they said, “Well, we have something to offer you. And we have this immunotherapy trial, and you would be one of the first patients to try this.”

Now, when they said first patient, I’m not quite sure if they meant the first colon cancer patient, I’m not sure. But they told me the name of it, and I said, “I’m in. I’m in.” Because I knew my friend had survived all these years, and I thought, “Well, I’ve gotten the worst diagnosis I can have, what do I have to lose?” So, I said, “I’m on board, I’m on board.”

Katherine Banwell:    

Mm-hmm. Did you have any hesitations?

Cindi Terwoord:        

Nope. No, I’m an optimistic person, and what they assured me was that I could drop out at any time, which I liked that option.

Because I go, “Well, if I’m not feeling well, and it’s not working, I’ll get out.” So, I liked that part of it. I also liked, as Dr. Funchain had said, you go in for more visits. And I like being closely monitored, I felt that was very good.

I’ve always kept very good track of my health. I get my records, I get my office notes from my doctor. I’m one of those people. I probably know the results of blood tests before the doctor does because I’m looking them up. So, I felt very confident in their care. They watched me like a hawk. I kept a diary because they were asking me so many questions.

Katherine Banwell:    

Oh, good for you.

Cindi Terwoord:        

I’m a transcriptionist, so I just typed out all my notes, and I’d hand it to them.

Katherine Banwell:    

That’s a great idea.

Cindi Terwoord:        

Here’s how I’m feeling, here’s…And I was very lucky I didn’t have many side effects.

Katherine Banwell:    

In your conversations with your doctor, did you weigh the pros and cons about joining a trial? Or had you already made up your mind that yes, indeed, you were going for it?

Cindi Terwoord:        

Yeah, I already said, “I’m in, I’m in.” Like I said, it had kept my friend alive for these many years, he’s still on it, and I had no hesitation whatsoever.

I wish more people – I wanted to get out there and talk to every patient in the waiting room and say, “Do it, do it.”

I mean, you can’t start chemotherapy then get in the trial. And if I ever hear of someone that has cancer, I ask them, “Well, were you given the option to get into a trial?” Well, and then some of them had started the chemo before they even thought of that.

Katherine Banwell:    

Mm-hmm. So, how are you doing now, Cindi? How are you feeling?

Cindi Terwoord:        

Good, good, I’m doing fantastic, thank goodness, and staying healthy. I’m big into herbal supplements, always was, so I keep those up, and I’m exercising. I’m pretty much back to normal –

Katherine Banwell:    

Oh, good for you.

Cindi Terwoord:        

– as far as my strength. I like to lift weights, and I run, so I’m pretty much back to normal.

Katherine Banwell:    

Good for you. Thanks so much for sharing your story with us.

Cindi Terwoord:        

You’re welcome.

Katherine Banwell:    

Dr. Funchain, once a patient like Cindi decides to participate in a trial, what happens next?

Dr. Pauline Funchain:    

So, there is a lot, actually, that happens. So, there is a lead-in period to a trial. So, once you decide, it’s not like you can start tomorrow on a trial drug. What happens really, there’s a whole safety lead-in that we call an enrollment period, where there’s a long checklist of making sure that a person is healthy, and there’s nothing – no organ or anything in particular – where we would be worried about this particular drug.

So, there’s a check list, that way there are usually – sometimes there’s a new scan if the last scan is a little bit too old, just so that we know exactly what somebody looks like right when they walk into the trial and start the drug. There are usually some blood tests and procedures that come before, and some of the stuff – half of the blood is for the trial, and half of the blood is for scientist usually, so that they can work on some of the science behind what’s happening to someone on a trial, which is pretty cool.

And sometimes there is a procedure – a biopsy or something like that – that’s involved.

But in general, the lead-in is somewhere usually between two and four weeks from the time somebody decides they’re willing to be on a trial. And there are some extra safety measures, like if you hear about a trial, you can’t go on the trial right away, there’s got to be sort of a thinking period that’s usually about 24 hours before you can literally sign your name on the line.

But, yeah, I’d expect something about two to three weeks before going on a trial. And then once folks are on a trial, it’s kind of like treatment. It’s just getting the treatments when you get the treatments. Sometimes there’s extra checks, again for safety, on drug levels and things.

Katherine Banwell:    

Would you review the safety protocols in place for clinical trials?

Dr. Pauline Funchain:    

Yeah, sure. So, safety is number 1 when it comes to trials, really. There are guardrails on guardrails on guardrails. But in any clinical trial protocol, it actually starts even before the trial starts. So, whenever somebody wants to bring in a trial, or wants to start a trial – and this is true at any academic institution, or any institution that runs trials – the trial goes through something called an IRB, or an Institutional Review Board, and that board reviews it and says, “Look, is this safe, are we harming people, are we unnecessarily coercing people?”

And they read through the whole thing. And usually there’s a protocol data monitoring committee that also looks at it, there’s usually two. And there’s a lot of checks that a trial has to go through to make sure it’s safe, and fair, for all participants. So, that happens first.

And then once the trial opens, there is continual monitoring. Every visit, ever number that’s drawn. Any visit, even if the visit isn’t at the hospital that’s running the trial, even if it’s at a local urgent care, all of those things end up getting reported back, and there’s a whole team of people besides.

So, a patient will see the doc, or the nurse, or maybe sometimes a research coordinator, research assistant. But then there are all these research coordinators that sit in offices that review everything, put it in the computers, and then record everything that happens to someone on the trial.

And all of that data actually goes to an external review organization, a clinical trial research organization. And what they do is, they look over all of the data also. So, it’s not just internal people checking, because internal people may be biased for the people that pay them, right?

Katherine Banwell:    

Right.

Dr. Pauline Funchain:    

All of that data goes to an external monitoring board also, to make sure that everything is going the way it’s supposed to go.

Katherine Banwell:    

Yeah. Cindi, in your experience, did you feel like safety was a priority?

Cindi Terwoord:        

Oh, definitely, definitely, yeah. They were very, very careful. Mine was a two-part; I had a vaccine along with this nivolumab.

And so, they would have to give me the vaccine, sit there and stare at me, to make sure I didn’t faint or something, and that was a good half-hour.

Then I got the immunotherapy, and I’d have to wait an hour after that before I started on the chemotherapy.

Katherine Banwell:    

Oh.

Cindi Terwoord:        

Yeah, they were in there watching me like a hawk, and I felt very safe, I really did.

Katherine Banwell:     

Dr. Funchain, what are a patient’s rights when they participate in a trial?

Dr. Pauline Funchain:    

So, the most important thing, I think, that Cindi mentioned before is, a patient can withdraw at any time. Any time. They can sign the paperwork, and the next second decide not to. They can be almost to the end of the trial and decide that they want to come off. The last word is always with the patient.

I think the other thing, in terms of safety, you can see – so every patient before starting a trial gets an informed consent. It is multiple pages, there’s a lot of legalees in it.

But they do try their best to make it as readable and understandable as possible, so that people can, even if they don’t have a medical background, kind of understand what they’ve gotten. The mechanism of what they’ve gotten, and what new drug they’re getting, and generally what are the risks and benefits.

For instance, let’s say there’s genetic testing involved, there’s always clauses that tell you what that means, and how protected your genetic information is, that kind of stuff.

So, it’s a very long thing. And again, once someone gets that, they have to have a certain amount of time before they can sign on the line. So, I think information education, and then the ability to come off if they find necessary.

Katherine Banwell:    

Yeah. What happens after a trial is completed? Is a patient monitored? And if so, how?

Dr. Pauline Funchain:    

So, that depends on the trial.

Most trials do monitor after either the drug is complete, or the course is complete for a certain amount of time, and it depends on the trial. For some trials, it’s six months after; for some trials, it’s years afterwards. So, in melanoma, we have a trial that just reported out their 7-1/2-year follow-up. But it was actually the first immunotherapy combination of its kind that involved the drug that you had Cindi, nivolumab.

So, it is pretty cool. I mean, that combination changed the face of what patients with melanoma could come to expect from their treatment, so we’re all very interested to know what that kind of follow-up is. But, yeah, it depends on the trial.

Katherine Banwell:    

Dr. Funchain, are there common clinical trial terms that patients should know?

Dr. Pauline Funchain:    

Yeah, there are trial terms that people hear all the time, and probably should know a little bit about. But I think the most common thing people will hear with trials are the type of trial it is, so Phase I, Phase II, Phase III. The important things to know about that are essentially, Phase I is it’s a brand-new drug, and all we’re trying to do is look for toxicity. Although we’ll always on the side be looking for efficacy for whether that drug actually works, we’re really looking to see if the drug is safe.

A Phase II trial is a trial where we’re starting to look at efficacy to some degree, and we are still looking at toxicity. And then in Phase III is, we totally understand the toxicity, and we are seeing promise, and what we really want to do is see if this should become a new standard. So, that would be the Phase I, II, and III.

Another couple of terms that people hear a lot about are eligibility criteria, or inclusion criteria. So, those are usually some set of 10 to 30 things that people can and can’t be. So, usually trials only allow certain types of cancer, and so that would be an inclusion criteria, but it will exclude other types of cancers. Most trials, unfortunately, exclude pregnant women. That would be an exclusion criteria.

So, these are things that, at the very beginning of a trial, will allow someone to enter, or say, “You’re not in the safe category, we should not put you on a trial.” Many trials are randomized, so people will hear this a lot. Randomization.

So, a lot of times, there is already a standard of care. When there’s already a standard of care, and you want to see if this drug is at least the same or better, then on that trial, there will be two different arms; a standard of care arm and experimental arm.

And then in order to be fair, a randomized trial is a flip of a coin. Based on a electronic flip of a coin – nobody gets to choose; not the doc, not the patient. On that type of trial, you’ll either get what you would normally get, standard of care, or something new. So, that’s a randomized trial. Not all trials are randomized, but some are. And those are the things that people will run into often.

Katherine Banwell:    

So, if a patient is interested in joining a clinical trial, where should they start?

Dr. Pauline Funchain:    

They can start anywhere. There are many places to start. I think their oncologist is a really, really good place to start. I would say a oncologist, depending on their specialties, will have a general grasp of trials, or a really specific grasp of trials.

I would say that the folks who have the most specific grasp on trials– what is available, what isn’t available, what’s at their center versus the next state over center – are the academic medical centers; the ones that are sort of university centers, places like the Cleveland Clinic where the docs are specialized by the type of cancer. That group of folks will have the best grasp on what’s current, what’s available.

And so, Cindi, your friend referred you. many people do say that. Just go to whatever your nearest university center is, just because there’s a lot more specialization in that sense. But I think it’s the age of the internet, so people can look online. Clinicaltrials.gov is a fantastic place to look. It is not as up to date, I think, as something you can get directly from a person at a medical center, but it is a great place to start.

There are many advocacy groups and websites that will point people to trials. I mean, there are Facebook groups and things, where people will chat about trials. But I think the detail is better at a site like clinicaltrials.gov, and even better with a cancer-specific oncologist at a academic medical center.

Katherine Banwell:    

If a trial is recommended, what questions should a patient ask about the trial itself?

Dr. Pauline Funchain:    

I mean, there’s so many questions to ask.

Katherine Banwell:    

Safety is definitely one of them, right?

Dr. Pauline Funchain:    

Yeah. I mean, I think when it comes to that, I think that the important things to ask, really, are what are the drugs involved, and what your doc thinks about those drugs.

I think, what is the alternative? So, again, we were talking about option A, B, and C. Is this option A of A, B, and C, or option C of A, B, and C? Are there ones like Cindi mentioned, where if you don’t do it at this point, you’re going to lose the opportunity, because you started on something else. Because a lot of trials require either that a person has never gone through therapy, and so this is sort of first line trial. But some trials are you have to be at the second thing that you’ve been on.

So, these are the things that matter to know. Are you going to lose an opportunity if you didn’t do it now, or can you do it later, and what is the preference? And I think, practically speaking, a patient really wants to know what is the schedule? Can I handle this? How far away do I live from the place that is giving this trial?

What are the locations available? Because if there’s a trial and you have to come in every two weeks, or come in four times in two weeks, and then once every month after that, that makes a big difference depending on where you live, what season it is, weather, that kind of stuff.

And I think the question that you don’t really have to ask, but a lot of people ask, is about cost. So, medical care nowadays is complex, it costs money when you don’t expect it to, it doesn’t cost money when it’s – you just don’t know what will and what won’t. Financial toxicity is something that we really care about. Every center is really trying its best, but it’s hard to do in this type of environment. So, people then get concerned that clinical trials might be even more complex.

I think clinical trials are much less complex in that way, because a lot more of it is covered by the sponsor, whatever that sponsor is, whether that sponsor is the National Institutes of Health, as a grant, or a pharmaceutical company.

But, in general, a clinical trial really should cost the same or less than whatever the standard medical care is; that’s the way they’re built. So, many, many people ask us that question, but I think that is the question that probably is less important than what are the drugs, what does your doc think about this, are you going to lose an opportunity if there’s a different sequence, and does this fit into your life and your schedule, and people who can give you rides.

Katherine Banwell:    

Yeah, right. Are there resources available to assist with the financial impact of a clinical trial?

Dr. Pauline Funchain:    

There are not specific resources for clinical trials; there are specific resources for patients in general, though. There are things like helping with utility bills sometimes, sometimes with rides, I think a lot of clinical trials do pay for things like parking. In general, many trials themselves have extra financial support in them. There was a trial I remember that paid for airfare and lodging, because there were only five centers in the country, and so we had people fly in, and the whole thing was covered.

It depends on the trial. But in terms of outside of trials, there are always patient advocacy groups and things like that, where certain things can get covered. But often, the types of things that get covered by those groups are the same things that get covered with normal medical care.

Katherine Banwell:    

Okay. Before we wrap up the program, Cindi, what advice do you have for patients who may be considering participating in a trial?

Cindi Terwoord:        

Do it. Like I said, I don’t see any downside to it. You want to get better as quickly as possible, and this could help accelerate your recovery. And everything Dr. Funchain mentioned, as far as – I really never brought up any questions about whether it would be covered.

And then somewhere along the line, one of the research people said, “Well, anything the trial research group needs done – like the blood draws – that’s not charged to your insurance.” So, that was nice, that was very encouraging, because I think everybody’s afraid your insurance is going to drop you or something.

And then the first day I was in there for treatment, a social worker came in, and they talked to you. “Do you need financial help? We also have art therapy, music therapy,” so that was very helpful. I mean, she came in and said, “I’m a social worker,” and I’m like, “Oh, okay. I didn’t know somebody was coming in here to talk to me.”

But, yeah, like I said, I’m a big advocate for it, because you hear so many positive outcomes from immunotherapy trials, and boy, I’d say if you’re a candidate, do it.

Katherine Banwell:    

Dr. Funchain, do you have any final thoughts that you’d like to leave the audience with?

Dr. Pauline Funchain:    

First, Cindi, I have to say thank you. I say thank you to every clinical trial participant, everybody who participates in the science. Because honestly, whether you give blood, or you try a new drug, I think people don’t understand how many other lives they touch when they do that.

It’s really incredible. Coming into clinic day in and day out, we get to see – I mean, really, even within a year or two years, there are people that we’ve seen on clinical trial that we’re now treating normally, standardly, insurance is paying for it, it’s all standard of care. And those are even the people we can see, and there are so many people we can’t see in other centers all over the world, and people who will go on after us, right?

So, it’s an amazing – I wouldn’t even consider most of the time that it’s a personal sacrifice. There are a couple more visits and things like that, but it is an incredible gift that people do, in terms of getting trials. And then for some of those trials, people have some amazing results.

And so, just the opportunity to have patients get an outcome that wouldn’t have existed without that trial, like Cindi, is incredible, incredible.

Katherine Banwell:    

Yeah. Dr. Funchain and Cindi, thank you both so much for joining us today.

Cindi Terwoord:        

You’re welcome, thanks for having me.

Dr. Pauline Funchain:    

Thank you.

Katherine Banwell:    

And thank you to all of our collaborators. To access tools to help you become a proactive patient, visit powerfulpatients.org. I’m Katherine Banwell, thanks for being with us today.

Participating in a Clinical Trial: What You Need to Know Resource Guide

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Heart Center Meditation

Heart Centered Meditation from Patient Empowerment Network on Vimeo.

Learn about cultivating present moment awareness by focusing your attention on the heart center.

See More from Rx for Community Wellness

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Body Scan Meditation

Body Scan Meditation

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Transcript:

Greetings everyone. Thank you for joining this Patient Empowerment Network program. In this practice session we will be cultivating present moment awareness by focusing attention on the heart center. Before we start the practice, I want to state that focusing your attention on the body can have a grounding effect. Nonetheless, if you find this practice difficult for whatever reason, including health related or a traumatic history, please do not force it. I encourage you to be gentle and kind to yourself. Accepting yourself where you are in the process. Attend softly and your capacity will build over time.

To start our practice, find a comfortable seat. A chair is perfectly fine. And you may make any arrangements to support your back if necessary. Or you may lie down on your back for this particular practice. Allow your eyes to softly close if you feel comfortable doing so. Begin to feel into the weight of your body being supported by whatever you are seated on or lying on. Begin to bring your attention to the center of your chest area, the heart center. To support you in this practice, you may bring a hand to place over the heart center. Feel into the warmth of your hand. The tenderness of your hand over the heart center. Feeling, sensing, noticing. Anchoring your mind to the heart center. If the mind wonders about, gently bring it back to focusing your attention on the heart center. Feeling into the heart center without judgment. You may keep your hand over your heart for the duration of the practice or you may remove it at any moment you feel comfortable doing so. Gently open your eyes. We hope you enjoyed this Patient Empowerment Network program.

Whole Body Meditation

Whole Body Meditation from Patient Empowerment Network on Vimeo.

 Learn about cultivating present moment awareness and staying grounded by attending to and being present with the whole body. Watch now.

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Body Scan Meditation

Body Scan Meditation

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Body Parts Meditation

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Transcript:

Greetings everyone. Thank you for joining this Patient Empowerment Network program. In this practice session we will be cultivating present moment awareness by focusing attention on the whole body. Before we start the practice, I want to state that focusing your attention on the body can have a grounding effect. Nonetheless, if you find this practice difficult for whatever reason, including health related or a traumatic history, please do not force it. I encourage you to be gentle and kind to yourself. Accept yourself where you are in the process. Attend softly and your capacity will build over time.

To start our practice, find a comfortable seat. A chair is perfectly fine. And you may make arrangements to support your back if necessary. Or you may lie down on your back for this particular practice. Allow your eyes to softly close if you feel comfortable doing so. Begin to feel into the weight of your body being supported by whatever you are seated on or lying on. Feeling into the heaviness of your body. Feeling supported. Being open to whatever arises without judgment of good or bad, without pushing anything away or grasping at anything. Just being present in your body to the best of your ability. Are you drawn to any part of your body? If so, allow yourself to go there with a soft attention without looking for anything in particular. Notice with curiosity and openness to your level of comfort without judgment. Feeling, sensing, noticing. Gently (bring) begin to come back to feeling the weight of your entire body being supported. Feeling into your whole body with a spacious curiosity and openness without judgment. Resting in your whole body. Your precious body. Gently open your eyes. We hope you enjoyed this Patient Empowerment Network program.

Body Scan Meditation

Body Scan Meditation from Patient Empowerment Network on Vimeo.

Learn about cultivating present moment awareness and staying grounded by scanning your body for sensations in a methodical fashion from head to toe. Watch now.

See More from Rx for Community Wellness

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Breath Counting Meditation

Breath Counting Meditation

Chest Breathing Meditation

Chest Breathing Meditation

Complete Breathing Meditation


Transcript:

Greetings everyone. Thank you for joining this Patient Empowerment Network program. In this practice session we will be cultivating present moment awareness by scanning the body for sensations. Before we start this practice, I want to state that focusing your attention on the body can have a grounding effect. Nonetheless, if you find this practice difficult for whatever reason, including health related or a traumatic history, please do not force it. I encourage you to be gentle and kind to yourself. Accept yourself where you are in the process. Attend softly and your capacity will build over time.

To start our practice, find a comfortable seat. A chair is perfectly fine. You may also make arrangements to support your back if necessary. Or you may lie down on your back for this particular practice. Allow your eyes to softly close if you feel comfortable doing so. Begin to feel into the weight of your body being supported by whatever you are seated on or lying on. Notice any sensations without judgment of good or bad, without pushing anything away or grasping at anything. Just allow yourself to notice to best of your abilities. If you do not feel anything it’s ok. No need to force it. Be open to whatever arises without judgment. Begin to softly bring your attention to the soles of your feet. You may wiggle your toes to help you go there. Attending to any sensations that may arise or not without judgment. Begin to move your attention from the soles of your feet up your legs like a scanning disc up to your knees. Softly scanning for any sensations without judgment. If you are not feeling anything it is ok. Just move along, not allowing your mind to get stuck. From your knees up your thighs to your hips. Scanning. From your hips up your torso; front, back and sides up to your shoulders. Bringing your attention to your hands. Feeling, sensing, noticing. From hands to your elbows. Elbows to your shoulders. From your shoulders up your neck to your head. All the way to the crown of your head, the very top of your head. Begin to work your way down from the crown of your head to the shoulders. Scanning, sensing. Down the arms to your hands. Back to your shoulders down the torso to the hips. From the hips down the legs to the soles of your feet. From here bring your attention back to feeling the weight of your body in your seat. Gently open your eyes. We hope you enjoyed this Patient Empowerment Network program.

Body Parts Meditation

Body Parts Meditation from Patient Empowerment Network on Vimeo.

Learn about cultivating present moment awareness and staying grounded by focusing your attention on different parts of the body.

See More from Rx for Community Wellness

Related Programs:

Breath Counting Meditation

Breath Counting Meditation

Chest Breathing Meditation

Chest Breathing Meditation

Complete Breathing Meditation


Transcript:

Greetings everyone. Thank you for joining this Patient Empowerment Network program. In this practice session we will be cultivating present moment awareness by focusing the attention on different parts of the body.

Before we start the practice, I want to state that focusing your attention on the body can have a grounding effect. Nonetheless, if you find this practice difficult for whatever reason, including health related or a traumatic history, please do not force it. I encourage you to be gentle and kind to yourself. Accept yourself where you are in this process. Attend softly and your capacity will build over time. To start our practice, find a comfortable seat. A chair is perfectly fine. And you may make arrangements to support your back if necessary. Or you may lie down on your back for this particular practice. Allow your eyes to softly close if you feel comfortable doing so. Begin to feel into the weight of your body being supported by whatever you are seated on or lying on. Notice any sensations without judgment of good or bad, without pushing anything away or grasping at anything. Just allow yourself to notice to the best of your abilities. If you do not feel anything, it’s ok. No need to force it. Be open to it. Whatever arises without judgment. Begin to softly bring your attention to your right foot. You may wiggle your toes to help you go there. Attending to any sensations that may arise or not without judgment. Begin to move your attention to your left foot. Attending softly without judgment. Moving your attention to your right leg. Feeling, sensing, noticing. Then bring your attention to your left leg. Moving to your right hand, attending softly without judgment. Then your left hand. Then to your right arm. Feeling, sensing, noticing. To your left arm. Bringing your attention to your head. Then your bringing your attention to your abdominal area, your belly area. Feeling, sensing, noticing. And then to your attention to your chest. From here bring your attention back to feeling the weight of your body in your seat. Gently open your eyes. We hope you enjoyed this Patient Empowerment Network program.

How Can Clinical Trials Be Accessed?

How Can Clinical Trials Be Accessed?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack and patient advocate Sujata Dutta explain the benefits of participating in a clinical trial. They review important questions to ask your doctor and share advice for finding a trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

What Is a Clinical Trial and What Are the Phases? 

Are Clinical Trials Safe?

A Patient Shares Her Clinical Trial Experience


Transcript:

Katherine Banwell:    

Sujata, there’s clearly a lot of hesitation and misconceptions out there. What would you say to someone who’s considering a trial but is hesitant?

Sujata Dutta:  

I would say speak to your provider, speak to your doctor, and get all these myths kind of busted to say, “it’s going to be expensive” or whatever those questions are. And then, through that process also try and understand what is it that the study is trying to achieve? How is that going to be beneficial to you? So, in my instance, it wasn’t the last line of defense, it was just one of the processes or combos that would help me. And so, that was important for me to understand and then a little bit of education as well. So, I was asking, I have questions on my phone every time I meet my provider, and I did the same thing. So, I think that one of the good practices is keep your note of your questions and have those questions ready. And no question is silly, all questions are important. So, ask as many questions as you can and use that opportunity to educate yourself about it.

And maybe you realize, “No. I don’t think it’s working for me” or “I don’t think this trial is good for me.” But it’s good, important, to have that conversation with your provider, that’s what I would recommend highly.

Katherine Banwell:    

Excellent. Thank you, Dr. Pollack, if someone is interested in participating, how can they find out about what trials are even available for them?

Dr. Seth Pollack:       

Yeah. I mean, the best thing to do is to start just by asking your doctor if they know about any clinical trials. And a lot of the times the clinical trials are run at the big medical centers that may be closer to you, so you could ask your doctor if there’s any clinical trials at the big medical center even. Or I always think it’s good to get a second opinion, you could go get a second opinion at the big medical center that’s close to you and ask them what clinical trials are at your center.

And sometimes they’ll be conscious about some of the clinical trials that may be even run around the country. And you can ask about that as well.

Katherine Banwell:    

Would specialists have more information about clinical trials than say a general practitioner?

Dr. Seth Pollack:       

So, I specialize in rare cancers, so a lot of the times the general practitioners they’ve got my cell phone number, and they text me, and they say, “Hey, do you have a clinical trial going on right now?” And that happens all the time, but yeah, the specialists will usually because frankly there’s so much to know. And the general practitioners really have a lot to keep track of with all the different types of diseases that are out there. Whereas at the big centers, the specialists, part of their job is really to keep their tabs on what’s going on with the clinical trials.

So, they’re good people to ask, either your local doctor could reach out to them, or you could go get a second opinion and ask.

Sujata Dutta:  

There’s also a lot of information, Katherine, on sites such as LLS, or PEN, or American Cancer Society that they also publish a lot of information. Of course, I would recommend once you have that information then vet it by your specialist, or whatever. But if you’re interested in knowing more about clinical trials in general and some that would work for you, then those are also some places to get information from.

Katherine Banwell:    

That’s great information. Thank you, I was going to ask you about that Sujata. Well, before we end the program, Dr. Pollack, I’d like to get your final thoughts. What message do you want to leave the audience with related to clinical trial participation?

Dr. Seth Pollack:       

Yeah. I think clinical trials it can be a very rewarding thing for a lot of patients to do, I think patients really like learning about the new treatments. And I think a lot of patients really like being a part of pushing the therapies forward in addition to feeling like sometimes they’re getting a little bit of an extra layer of scrutiny, because there’s a whole extra team of research coordinators that are going through everything.

And getting access to something that isn’t available yet to the general population. So, I think there’s a whole host of advantages of going on clinical trials, but you need to figure out whether or not a clinical trial is right for you.

Katherine Banwell:    

Yeah. Sujata, what would you like to add?

Sujata Dutta:  

Absolutely, I second everything that Dr. Pollack is saying. And in my personal experience I wouldn’t say everything is hunky-dory, everything is fine. I’m going through treatment, I have chemo every four weeks, I started with chemo every week. That’s when the logistics pace was really difficult because going to Mayo every week was not easy. But anyways, as the trial progress itself every four weeks, but as I said the benefits are huge because I have labs every four weeks. I meet my provider every four weeks.

So, we go through the labs and anything amiss, I’ve had some changes to my dosage because I’ve had some changes in the labs. And so, there’s a lot of scrutiny which I like, but the flip side, for maybe some maybe like, “I have to have chemo every four weeks. Do I want to do that or not?” Or whatever. In my case, I knew it, and I signed up for it, and I’m committed to doing that for two years. And so, I’m fine with that. So, I would say all in all, I’d see more benefits of being in a clinical trial. One, you’re motivated to give back to the community. Two, you are being monitored and so your health is important to your provider just as it is to you. And so, I highly recommend being part of a trial if it works for you and if you’re eligible for one.

Are Clinical Trials Safe?

Are Clinical Trials Safe?  from Patient Empowerment Network on Vimeo.

Clinical researcher Dr. Seth Pollack explains the safety protocols in place for clinical trials, including how data is reported and protected. Patient advocate Sujata Dutta goes on to share her experience in a clinical trial.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

A Patient Shares Her Clinical Trial Experience

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?


Transcript:

Katherine Banwell:

Some patients feel that clinical trials aren’t safe, is that the case, Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, we go through, as I was saying before, these clinical trials are extensively vetted. So, the safety is, of course, one of the things that we look most carefully about. But as I was saying before, like with any treatment’s cancer treatments have toxicity, that’s a common problem. So, and when you’re dealing with something brand new sometimes there is a little bit more risk. So, when you’re talking about these very early-stage Phase I trials you probably want to talk to your doctor about what sorts of toxicities you can expect and where they are in the Phase I trial. Are you the first ever to receive this new drug? And if you are nobody’s making you go in the clinical trial, so it can only help to get more information. Right? So, you should ask your team about it, you should find out. 

Most of the time there’s going to be a lot of patients that have been treated already, I mean, they can’t give you definitive data about how things are going but they can maybe say, “Hey. I’ve already treated a few patients on it, and they seem to be doing great.” 

Katherine Banwell:

So, you need to weigh the pros and cons of the trial. 

Dr. Seth Pollack:

You do need to weigh the pros and cons. Now, when you’re talking about these Phase IIs and Phase IIIs, I mean, these are drugs now that have really been vetted for their safety and we have a lot of data about it. And even the Phase Is, it’s not like these things are coming out of nowhere, they’ve been scrutinized, we really expect that they’re going to be safe but we’re doing the trial to prove it. So, it’s a good thing to ask about. 

Katherine Banwell:

Yeah, yeah. 

Sujata Dutta:

Yeah. I would also add that it’s so closely monitored that safety is a top priority, it’s front and center. So, the advantage, I think, with being on a trial is the close monitoring of the patient exactly for this reason. 

If something is amiss it’s going to be picked up as quickly as possible and you’re any issues are going to be addressed as soon as. So, I think, safety does get addressed pretty quickly.  

Katherine Banwell:

Good. 

Can data from trials even be trusted? Dr. Pollack, is that the case? 

Dr. Seth Pollack:

Well, of course, I mean, it can be trusted. Because the thing with the clinical trial data is that you really see the data and there’s all kinds of scrutiny making sure that the data is reported accurately. Now, there’s a whole other conversation we could have as to whether we could interpret the data differently. And sometimes that is an issue that comes up, but the data is reported very accurately. 

So, and there are statistics that are very well understood, and the bar is actually pretty high to say one arm of the trial was better than the other arm of the trial. So, if patients have better survival on one arm, if we say that, usually it means they did considerably better. Enough better that it wasn’t a random chance that one extra patient did better on the treatment arm. No. There were enough patients that did better that the statisticians can go through it with a fine-toothed comb. And they can be absolutely sure up to exactly how many percent sure they can tell you, 0.05 percent or less chance of error that this was a real difference between the study arm and the standard of care arm. 

Sujata Dutta:

I think you mentioned too that one is trust, and one is data. So, Dr. Pollack mentioned a lot about the data, I think the trust is also a very important thing. I like to go with positive intent because I do not have a reason to believe my doctor has some ulterior motive to suggest a clinical trial. And so, I trust them wholeheartedly. The first hurdle is you have to trust the system or what is being proposed to you because, as Dr. Pollack said, it’s gone through a lot of vetting. A recommendation to be part of a trial itself is vetted by your doctor when they make the recommendation. So, have faith, trust, that they are making a good recommendation. And then, of course, the data, I don’t know much about that, but as I said, I trust it. So, I would trust the data too. 

Katherine Banwell:

Of course. Of course. Some patients feel like they’re going to lose their privacy. Sujata, did you feel that at all? 

Sujata Dutta:

No. Not at all. 

I mean, with everything else that is also taken care of, my information, or whatever, is not made available to anybody. And so, obviously there’s a lot of people will get those, and I had a huge pile of paperwork to go through, but I think that’s a good thing. For my peace of mind that I knew that my information was not going to be shared outside of the study, the trial, etc., and things. So, no, I don’t think that’s a problem. 

Katherine Banwell:

Beyond these misconceptions is there anything else you hear? Dr. Pollack?  

Dr. Seth Pollack:

No. I mean, look, in our crazy modern world there’s concerns everywhere, but the clinical trial is very, very careful. Whenever possible we use the medical chart.  

And then, we have a very stringently protected database that’s storing people’s information, but it’s deidentified. So, I mean, we have a separate key to figure out who the patients are and then we try to limit the use of the patient’s name or any identifying information about them beyond that. So, and your information is not shared. For example, if there’s a drug company involved in the trial, your information is not shared with the drug company, you have a new identifier that is unique and not traceable back to you that is provided to whoever, if there’s outside groups working on the trial with you. So, your information is very carefully protected, and everyone is very conscious about issues regarding privacy.  

Katherine Banwell:

That’s great to know.  

Are Clinical Trials a Logistical Nightmare?

Are Clinical Trials a Logistical Nightmare?  from Patient Empowerment Network on Vimeo.

PEN board member and myeloma survivor Sujata Dutta shares how her family managed the logistics of her clinical trial participation.

Sujuta Dutta is a myeloma survivor and empowered patient advocate, and serves a Patient Empowerment Network (PEN) board member. Learn more about Sujuta, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?


Transcript:

Katherine Banwell:    

The logistics will be a nightmare and I don’t live close to a research hospital. Sujata, did you have that issue?

Sujata Dutta:  

Yeah. That’s a very interesting one, and actually I’ll share my experience. I did have this concern about logistics, because I got my transplant at Mayo Rochester, which is a two-hour drive from where I live. And so, when I got to know about it literally me and my husband were like, “Oh, my gosh. What are we going to do?” It’s not just me, my husband is my caregiver, he has to take the day off to drive me to Mayo, wait through my treatment, and drive me back. Then we have boys who were distance learning at the time, and so what do we do with them? Do we drop off a friends or take a favor from a friend? And so on and so forth.

So, the logistics was an issue and we literally said, “Thanks but no thanks” and we walked out of the room. And we came downstairs, and my husband was like, “What the heck?” My team understands everything, and I fortunately work for a very good employer, and they understand everything, people first. And so, he was like, “I can figure this out. Let’s do it if this is what’s going to help you, then let’s just figure this out.” And at that time, it was so good, and I have total respect for Dr. Pollack.

You and everybody in this medical community. My doctor who leads the trial at Mayo, she actually said, “Why don’t you check with your local cancer center? Maybe they are also approved by FDA, and they may be able to administer this treatment to you.” Unfortunately, at that time they weren’t but we were like, “We’re going to go ahead with the trial. It doesn’t matter.” My husband was like, “I’ll take the day off, you don’t worry about it.” And then, four months later my institute did get approved by FDA, and so I was able to transfer from Mayo to my local cancer center, Abramson Cancer Center, which is 20 minutes from home. And so, there are options, I know that it can be an issue and it can be overwhelming at the time which was the case with me. But I was able to overcome that, so maybe there are options available that the patients can consider.

Is It Expensive to Participate in a Clinical Trial?

Is It Expensive to Participate in a Clinical Trial?  from Patient Empowerment Network on Vimeo.

Is there a financial cost to participating in a clinical trial? Dr. Seth Pollack explains how clinical trials participation is billed and potential financial impacts.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is a Clinical Trial a Last-Resort Option?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Is this fact or fiction; it will be expensive? Dr. Pollack?

Dr. Seth Pollack:       

That’s fiction because the way the clinical trials work is we go through everything very carefully to figure out what things are standard and what things are unique to the clinical trials. So, if you are getting chemotherapy, you’re going to need blood work, you’re going to need the chemotherapy drugs, you’re going to need some sort of imaging, CT scan, or whatever your doctor would do.

And all those sorts of things are considered standard, so your insurance company is built for those. Then there’s a bunch of things that are considered research. For example, there’s special research bloodwork, maybe there’s an investigational agent that’s being added to standard chemotherapy. Those things are billed to the study, so you don’t actually have to pay anything extra, it’s just like you’re getting the normal treatment as far as you’re concerned. I mean, that’s the way it always is, and I haven’t had any of my patients ever get into real problems in terms of the finances of these things. It always works very straight forward like standard therapy.

Is a Clinical Trial a Last-Resort Option?

Is a Clinical Trial a Last-Resort Option?  from Patient Empowerment Network on Vimeo.

Are clinical trials only meant as a last-resort option? Dr. Seth Pollack debunks this common clinical trial misconception and explains why he feels patients should participate when the opportunity arises.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Right. And another concern that people have is; clinical trials are my last resort treatment option. What do you say to that Dr. Pollack?

Dr. Seth Pollack:       

Yeah, no. That’s a common misconception. So, we like to have clinical trials for every phase of the patient’s cancer journey because we’re trying to make every single part of the cancer journey better. So, I think a lot of people think that, okay, when they hit their last resort that’s kind of the time to try something new. Even in the very earliest parts of the cancer journey, even in the diagnosis phase sometimes we’ll have clinical trials where we’ve tried different images, modalities, or look at things in a different way in terms of the biopsies.

But then, in terms of the cured-of treatments, when somebody is in the cured-of setting we don’t usually try something very brand new. But a lot of the times we’ll try something that is very affective for patients at the end, and we want to try and make the cured-of strategy even better. So, a lot of the times for those patients we’ll have new therapies that are very safe and established that we’re trying to incorporate earlier into patients’ treatments because we know they work really well, right? And then, even in patients who have incurable cancer a lot of times it’s better to try a clinical trial earlier on just because sometimes the clinical trials have the most exciting new therapies that are bringing people a lot of hope.

And a lot of the times you want to try that when you’re really fit and when you’re in good shape. So, that’s why I think that you really want to think about doing a clinical trial when the opportunity arises.

Katherine Banwell:    

Yeah. Beause it could be beneficial to you and it’s certainly going to be beneficial to other people.

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?

If I Participate in a Clinical Trial, Will I Be a Guinea Pig?  from Patient Empowerment Network on Vimeo.

Does participating in a clinical trial make you a “guinea pig” for new treatments? Clinical researcher, Dr. Seth Pollack, provides a clear explanation of clinical trial safety protocols.

Dr. Seth Pollack is Medical Director of the Sarcoma Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and is the Steven T. Rosen, MD, Professor of Cancer Biology and associate professor of Medicine in the Division of Hematology and Oncology at the Feinberg School of Medicine. Learn more about Dr. Pollack, here.

See More from Clinical Trials 101

Related Resources:

Is It Expensive to Participate in a Clinical Trial?

Are Clinical Trials Safe?

Are Clinical Trials a Logistical Nightmare?


Transcript:

Katherine Banwell:    

Well, I’d like to address a list of common concerns about clinical trials that we’ve heard from various audience members prior to this program.

And this is probably the most common; I will be a guinea pig. Dr. Pollack, how do you respond to that?

Dr. Seth Pollack:       

Yeah. I know that is a common concern. I mean, I think the thing that people have to understand about clinical trials is there is just so much oversight that happens for these clinical trials. Every document, every procedure, is scrutinized by multiple committees. There’s a scientific review committee, there’s a review board, IRB, that reviews these. Many of these trials are reviewed by the FDA and they’re reviewed by your doctor and your doctor’s colleagues that are also participating in the trial. So, every detail is discussed at length.

In fact, a lot of the times there’s a lot more structure to being on the clinical trial than just routine clinical care because they’ve thought so thoroughly about when everything needs to be done and what the right timing of is for the various procedures.