Tag Archive for: Cleveland Clinic

What Do Patients Need to Know About Head and Neck Cancer Research?

What Do Patients Need to Know About Head and Neck Cancer Research? from Patient Empowerment Network on Vimeo.

Is there developing research that head and neck cancer patients should know about? Dr. Jessica Geiger explains how treatment approaches are evolving and how patients can stay up-to-date on the latest advances.

Dr. Jessica Geiger is a medical oncologist at the Cleveland Clinic. Learn more about Dr. Geiger

See More From The Pro-Active Head and Neck Cancer Patient Toolkit

Related Programs:

How Is Head and Neck Cancer Treated

How Is Head and Neck Cancer Treated?

What Are the Types of Head and Neck Cancer

What Are the Types of Head and Neck Cancer?

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients


Transcript:

Katherine Banwell:

Cancer research is developing rapidly. What are you excited about when it comes to head and neck cancer research? 

Dr. Jessica Geiger:

Well, I think there’s a lot of different clinical trials that are coming out in what we call the neo-adjuvant space so before you go for a surgery. Again, head and neck cancer is a little bit different when we think of other more common cancers. 

And what I mean by that is it’s one thing to be able to surgically remove cancer or to ablate it completely with radiation. The problem with the head and neck area as you can imagine, it’s such a small area. There’s a lot of precious real estate there, as I always describe to patients. And so, it’s one thing to cure the cancer, to cut it out completely. But then we have functional and sometimes cosmetic concerns after that, too. So, I think one of the biggest things that we are always trying to look to be successful in is are there therapies, are there treatments where we can shrink down the initial cancer so that the resulting surgery or the fields of radiation are not so severe? So, we’re maintaining the cure rates that we have. We’re improving on the cure rates that we have. But also thinking about how can we improve the quality of life and the function and the cosmetic outcome after their cancer treatment? And I think that’s really exciting. 

Katherine Banwell:

It is. It’s great.  And I’m sure there’s been so much development in the field, even in the last 10 years. 

Dr. Jessica Geiger:

There has. And another comment to make on that point, too, when we’re thinking about clinical trials especially. There’s really two big subsets of squamous cell cancer, head and neck squamous cell carcinoma, and that’s HPV-positive that’s related to the HPV, the human papilloma virus and HPV-negative. HPV-negative is what we think of historically as being caused by years of smoking often with heavy drinking. That’s kind of the traditional head and neck cancer patient. But over the last couple of decades now, there’s a completely different disease that we have recognized. And that’s related to HPV. And these patients tend to be light or never smokers at all. They tend to be younger, different demographic of patients. The good news is those cancers seem to respond better to cancer treatment, particularly radiation- and chemotherapy-based. 

So, as I mentioned before, trying a neo-adjuvant approach to kind of reduce the impact of surgery or the impact of radiation, particularly with HPV-related disease. We know that it’s a different disease that behaves much better than HPV-negative. So, trying clinical trials to what we call de-intensify therapy. So, maintaining the high cure rate. But reducing the toxicities related to treatment so that – you know, these are younger patients. They’re cured of their cancer. But they still require a feeding tube. Or they have a lot of chronic pain in the neck. They have a lot of morbidity with the treatment. And so, trying to reduce that down to again, maintain high cure rates, but help with quality of life in the years to come. 

Katherine Banwell:

How can patients stay up-to-date on developing research? 

Dr. Jessica Geiger:

That’s a really good question. 

Every once in a while, there are sound bites or news articles that are kind of in the mainstream press and in the mainstream news. I would just encourage patients to – if they read something or see a headline to reach out to their oncology team and have a discussion. What is this research? What does it mean for me? Does it apply to me? How is this information being used for cancer treatment? How would this impact my treatment or my follow up? It’s really hard to kind of navigate through what is, in terms of research, what is immediately clinically impactful or clinically meaningful at that time. 

Katherine Banwell:

Are there any websites that you recommend to patients? 

Dr. Jessica Geiger:

The American Head and Neck Society has a good website. And there’s a couple of other, depending on what state you live in or regions of certain states.  

There’s a lot of different support groups for head and neck cancer patients that I would encourage patients to reach out. Because especially in the regional, geographic location where you are, it may be worthwhile to be able to have those conversations. Because you can walk down the street and not know if somebody’s had it. But I’ve had more patients over the last several months, especially HPV-related disease patients who have mentioned something to me along the lines of, “I had mentioned to an acquaintance or a friend of a friend. And suddenly, I know three or four other people who have had this cancer. And I had no idea. And now we’re talking about how we have to carry a water bottle with us all the time because we can’t swallow dry foods. And how we have to be very mindful of what we’re eating when we order at a restaurant.” And so, just trying to navigate a bigger world, narrowing it down to where you live to have those meaningful contacts of other patients who have gone through what you have gone through. 

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients from Patient Empowerment Network on Vimeo.

What steps should newly diagnosed head and neck cancer patients take following a diagnosis? Dr. Jessica Geiger shares advice to help patients play an active role in their care.

Dr. Jessica Geiger is a medical oncologist at the Cleveland Clinic. Learn more about Dr. Geiger

See More From The Pro-Active Head and Neck Cancer Patient Toolkit

Related Programs:

How Is Head and Neck Cancer Treated

How Is Head and Neck Cancer Treated?

What Are the Types of Head and Neck Cancer

What Are the Types of Head and Neck Cancer?

What Do Patients Need to Know About Head and Neck Cancer Research

What Do Patients Need to Know About Head and Neck Cancer Research?


Transcript:

Katherine Banwell:

What three key pieces of advice would you have for a patient who’s just been diagnosed with head and neck cancer?  

Dr. Jessica Geiger:

Well, first, obviously, you have to see an oncologist you have trust and faith in. 

And whether that oncologist is a surgical oncologist which for this disease would be a head and neck cancer specialist, an ENT, or a head and neck surgeon. So, just make sure that you are comfortable with your team, because it can be a very long process in terms of treatment as well as recovery and ongoing surveillance. That’s number one. I think number two is seek out clinical trials if you have the opportunity to do that. This is a disease that’s not rare, but it’s not as common as breast cancer or colon cancer or prostate cancer. You could go to almost any general practicing medical oncology office, and they may or may not have very many head and neck cancer patients at a given time, because it’s much rarer compared to the other more common adult cancers. 

So, if you have the opportunity to seek out a clinical trial, I think that is great because we don’t have a lot of different types of therapies like you see with other cancers. 

Katherine Banwell:

Yeah. 

Dr. Jessica Geiger:

And then number three, and I can’t stress this enough, even early on in your head and neck cancer journey, again, whether it’s a very early-stage cancer or later-stage cancer. I think getting involved with the appropriate support specialties, meaning speech and language pathology, dental care, occupational therapy.  We couldn’t do what we do without some of these support specialties. And especially speech and language pathology for swallowing, it can’t be stressed enough that early intervention can be really meaningful and really impactful on function after head and neck cancer treatment.  

Katherine Banwell:

Mm-hm.  Dr. Geiger, what is your advice to patients who may feel like they’re hurting feelings by seeking a specialist or even a second opinion?  

Dr. Jessica Geiger:

So, first of all, I know it’s easier said than done, you shouldn’t worry about hurting anyone’s feelings. At the end of the day, you need to be in charge of your health. And you need to be an advocate for yourself or an advocate to your family members who may be going through this. So, I think you need to do what is best for you and what you feel most comfortable about. And if that is seeking an opinion elsewhere, I think if your provider – you’re asking for a second opinion gets their feelings hurt or is a bit offended. I would consider that to be a pretty big red flag. I have patients all the time who may ask me for a second opinion, or they want to go to a different institution for an opinion to see what else is out there. And sometimes I even offer to reach out to different contacts that I know at different other institutions if there’s something that I think may be better than what I can offer them with what we have. 

Especially when it comes to clinical trials. So, I would just try to empower the patients to – this is your life. This is your health. And you can’t worry about what us in the medical profession are going to worry about. For most of us, I would say there’s a lot of patients. We want to do what is best for each and every one of them. And if it’s not with us, then please let me help you find someone who is better for you. 

How Is Head and Neck Cancer Treated?

How Is Head and Neck Cancer Treated? from Patient Empowerment Network on Vimeo.

Once a patient is diagnosed with head and neck cancer, what are their treatment options? Dr. Jessica Geiger provides an overview of current therapies.

Dr. Jessica Geiger is a medical oncologist at the Cleveland Clinic. Learn more about Dr. Geiger

See More From The Pro-Active Head and Neck Cancer Patient Toolkit

Related Programs:

What Are the Types of Head and Neck Cancer

What Are the Types of Head and Neck Cancer?

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients

What Do Patients Need to Know About Head and Neck Cancer Research

What Do Patients Need to Know About Head and Neck Cancer Research?


Transcript:

Katherine Banwell:

How is head and neck cancer treated? 

Dr. Jessica Geiger:

The thing about head and neck cancer is even if it’s a very early-stage cancer, certainly if it’s a later stage with very big tumors that have spread, even the small cancers are often treated with many different modalities, many different medical specialties and surgical specialties. So, primarily, it’s going to be treated with head and neck surgery, sometimes with radiation, and then of course, you can require some systemic therapy which is what I do. And systemic therapy could be standard chemotherapy as you think about it. It could be targeted therapy. It could even be immunotherapy.  

Katherine Banwell:

Okay.  

Dr. Jessica Geiger:

And sometimes we have to use two or three of those different tools to get the job done. 

What Are the Types of Head and Neck Cancer?

What Are the Types of Head and Neck Cancer? from Patient Empowerment Network on Vimeo.

What is head and neck cancer? What cancers are included in this classification? Dr. Jessica Geiger provides a definition and reviews the main types of head and neck cancer.

Dr. Jessica Geiger is a medical oncologist at the Cleveland Clinic. Learn more about Dr. Geiger

See More From The Pro-Active Head and Neck Cancer Patient Toolkit

Related Programs:

How Is Head and Neck Cancer Treated

How Is Head and Neck Cancer Treated?

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients

Expert Advice for Newly Diagnosed Head and Neck Cancer Patients

What Do Patients Need to Know About Head and Neck Cancer Research

What Do Patients Need to Know About Head and Neck Cancer Research?


Transcript:

Katherine Banwell:

What is head and neck cancer? 

Dr. Jessica Geiger:

Head and neck cancer is sort of a broad term to include all cancers, all malignancies within the upper aero-digestive system. When we think about head and neck cancer, the vast majority of those cancers are going to be squamous cell carcinomas that start anywhere from the tip of the tongue to the back of the throat to the voice box area. But head and neck cancer can also include cancer of the salivary glands, skull base, or sinus cancers as well.   

Katherine Banwell:

What are the types of head and neck cancer? And where can they start in the body? 

Dr. Jessica Geiger:

There are several different types. The majority of them are called squamous cell carcinomas. Squamous cell cancers or squamous cell carcinoma encompasses over 90 percent of head and neck cancers.  

And those can start anywhere on the tip of the tongue, anywhere in the oral cavity, the tonsils, the back of the throat called the oropharynx, or also in the larynx or around the voice box in those areas. But head and neck cancer can also include salivary gland cancers of which there are dozens of different recognized histologies.  These are cancers of the larger, major salivary glands like the parotid glands or the submandibular glands. But they can also include cancers of minor salivary glands that aren’t even named but are found all over the upper aero-digestive mucosa and are there. Head and neck cancers can also include what we refer to as skull-based tumors or midline sinus, peri-sinus cancers as well.  

What Questions Should Patients Ask About Joining a Clinical Trial?

What Questions Should Patients Ask About Joining a Clinical Trial? from Patient Empowerment Network on Vimeo.

Before participating in a clinical trial, what questions should you ask? Dr. Pauline Funchain of Cleveland Clinic shares critical questions patients should ask their healthcare team when considering 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.

Katherine Banwell:

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

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. 

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

How to Find a Clinical Trial That’s Right for You from Patient Empowerment Network on Vimeo.

If you are interested in participating in a clinical trial, where do you start? Dr. Pauline Funchain of Cleveland Clinic shares resources for patients on where to find and access a clinical trial that’s right for them.

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.

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 an 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. 

Understanding Common Clinical Trial Terminology

Medical terminology can be confusing and is especially important to understand when reviewing information to learn about a clinical trial. Dr. Pauline Funchain of Cleveland Clinic explains common terms and phrases to help patients better understand the clinical trial process.
 
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.

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. 

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

You’ve Chosen to Participate in a Clinical Trial: What Are Next Steps? from Patient Empowerment Network on Vimeo.

What is it like to participate in a clinical trial? Dr. Pauline Funchain of Cleveland Clinic explains what to expect when joining a clinical trial and colorectal cancer survivor Cindi Terwoord shares her personal experience.

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:

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 checklist, 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?  

Pauline Funchain:

Yeah, sure. So, safety is number one 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, every 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 (Opdivo).  

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 legalese 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 to need 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.  

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. 

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.

Who Should Be on Your Bladder Cancer Care Team?

Who Should Be on Your Bladder Cancer Care Team? from Patient Empowerment Network on Vimeo.

Dr. Shilpa Gupta of Cleveland Clinic provides an overview of the multidisciplinary bladder cancer care team and discusses the key role of the patient on the team. 

Dr. Shilpa Gupta is the Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. Dr. Gupta’s research interests are novel drug development and understanding biomarkers of response and resistance to therapies in bladder cancer. Learn more about Dr. Gupta, here.

See More From The Pro-Active Bladder Cancer Patient Toolkit

Related Programs:

 
What Are Treatment Goals for Bladder Cancer?

What Are Treatment Goals for Bladder Cancer?

Current Treatment Approaches for Bladder Cancer

Current Treatment Approaches for Bladder Cancer

The Importance of Patient Self-Advocacy in Bladder Cancer Treatment


Transcript:

Katherine:                  

You’ve spoken about a multidisciplinary care team for bladder cancer patients. Who are the members of that team?

Dr. Gupta:                  

So, the multidisciplinary care team are all the key players who participate in patient’s care.

The urologist who, for the most part, diagnoses patients. Because patients are, let’s say, having blood in the urine, they see a urologist, bladder mass.

Then it’s the medical oncologist like us who are kind of the neutral folks where even if the patient is undergoing surgery, we offer some treatment. If a patient is undergoing radiation, we offer some treatment. If a patient is metastatic disease, then sometimes, they just see us, unless they have some complications or if they have a new spot in the bone where we want them to get radiated then we include that.

Then there’s the radiation oncologist, whose role comes for patients with localized disease. So that a patient, when they are diagnosed with bladder cancer and have localized disease, they should know all their options. That surgery is one option. 

Radiation can be another option, and they have options to preserve their bladder too. I think that’s what a multidisciplinary clinic comprises.

The Importance of Patient Self-Advocacy in Bladder Cancer Treatment

The Importance of Patient Self-Advocacy in Bladder Cancer Treatment from Patient Empowerment Network on Vimeo.

Bladder cancer expert Dr. Shilpa Gupta encourages patients to advocate for themselves and to become active members in their treatment and care decisions.

Dr. Shilpa Gupta is the Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. Dr. Gupta’s research interests are novel drug development and understanding biomarkers of response and resistance to therapies in bladder cancer. Learn more about Dr. Gupta, here.

See More From The Pro-Active Bladder Cancer Patient Toolkit

Related Programs:

 

Emerging Approaches in Bladder Cancer Treatment

Understanding Common Bladder Cancer Treatment Side Effects

Understanding Common Bladder Cancer Treatment Side Effects

Who Should Be on Your Bladder Cancer Care Team?


Transcript:

Katherine:                  

Right. Let’s talk about patient self-advocacy for a moment. Patients can sometimes feel like they’re bothering their healthcare team with their comments and their questions. Why is it important for patients to speak up when it comes to symptoms and side effects?

Dr. Gupta:                  

Yeah, I think the patients have to be their own advocates, right? Unless they do tell their team about what they are going through, many times action will not be taken unless they’re actually seeing their team in real-time.

And sometimes that visit may not be happening for months so it’s very important to never feel that you’re bothering the teams. And nowadays, with all these electronic ways where patients can communicate with their teams, I think patients are very aware that they can send a MyChart message, for example, and someone will get back to them within a day. So, I think that is really important and the way they can communicate with their teams has also evolved.

Katherine:                  

How do you think patients can feel confident in speaking up and becoming a partner in their own care?

Dr. Gupta:                  

I think they have to tell their doctors during their visit that they would like to – whatever their expectations are and what they would like their teams to do to fulfill those expectations.

I think that’s the best way I can say this. That they should always speak up no matter what and if they feel that their concerns about treatment are not being heard, then they should let their treatment teams know and ask what alternative treatments there may be. Or, if their life goals have changed, sometimes patients want to get aggressive treatment and sometimes they just don’t want to go through it anymore. They should let their teams know so, adequately; the goals of care can be modified.

Katherine:

Right. If a patient isn’t feeling confident with their treatment plan or their care, should they consider a second opinion or consulting a specialist?  

Dr. Gupta:

Absolutely. I think every patient has a right to consult a second opinion or get second opinions, or even more opinions if they want to make the right decision. Many times, patients are told about one treatment option, and then they want to know, “Well, what alternative options do I have?” “What if I really don’t want my bladder out?” “Is there anything else that can be done?” So, they should be seeing a radiation oncologist in that case.  

I think the way we can really make a difference and offer multidisciplinary care is to have the patient see a surgeon, a radiation oncologist, and a medical oncologist. That’s true multidisciplinary care for anybody with localized disease. For metastatic disease, we have a lot of options and usually medical oncologists are the ones who manage it.   

Patients can always get second opinions if they feel they want to do something less or more aggressive.   

Katherine:

What advice to have for patients who may be nervous about offending their current doctor by getting a second opinion?  

Dr. Gupta:

That’s a great question, Katherine, and I know a lot of patients feel that their doctors may feel offended, but in my experience when – if my patients are not local or they – I actually encourage them to go get second opinions and even make referrals to places which may have trials if we don’t have that. It’s always good to have the patients be able to decide and I don’t think nowadays doctors take offense if patients want to get another opinion. In fact, we try to collaborate with our community oncologists.  

Where, let’s say patients are currently being treated and they come to us to discuss trials or just to discuss if they’re on the right track. We reassure them and reach out to the community doctors that – yes, we totally agree with what the patient is doing, and these are some other options down the line. And, with the advent of virtual health it’s really become a lot more collaborative because patients are still getting treated locally. When the have their scans and have questions they can schedule a virtual appointment with their doctors in institutions where we have more treatment options like trials.  

Katherine:

Dr. Gupta, if patients want to learn more about bladder cancer, or if their families want to learn more what are some credible resources that you would send people to?  

Dr. Gupta:

Yeah, I think it’s always good to get credible information than just Googling things which may or may not be true. Bcan.org is a very powerful resource that is a Bladder Cancer Advocacy Network, and as the name implies it’s for the patients, made by bladder cancer advocates.   

That’s one of the resources that we highly recommend. Then there’s the resource that you all are working on. So, I think these collectively are the best sources of information which patients should try to stick to.   

Katherine:

Right. That’s good advice. To close, what would you like to leave our audience with? What are you hopeful about?  

Dr. Gupta:

I think I would like to say that there’s a lot of good information, there’s a lot of advocacy resources. Patients should try to get their information from these verified sources and bring it to their care teams. And never hesitate to reach out for whatever they need during their diagnosis and treatment phase. Always ask questions. Ask about clinical trials. Ask about alternative options. That’s what I would leave the message to be.   

Katherine:

Thank you so much for joining us today, Dr. Gupta. We really appreciate it.   

Dr. Gupta:

Thank you, Katherine.   

Emerging Approaches in Bladder Cancer Treatment

Emerging Approaches in Bladder Cancer Treatment from Patient Empowerment Network on Vimeo.

Dr. Shilpa Gupta of the Cleveland Clinic shares a promising update in bladder cancer treatment and research, including the benefits of patient participation in clinical trials. 

Dr. Shilpa Gupta is the Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. Dr. Gupta’s research interests are novel drug development and understanding biomarkers of response and resistance to therapies in bladder cancer. Learn more about Dr. Gupta, here.

See More From The Pro-Active Bladder Cancer Patient Toolkit

Related Programs:

 

The Importance of Patient Self-Advocacy in Bladder Cancer Treatment

What Are Treatment Goals for Bladder Cancer?

What Are Treatment Goals for Bladder Cancer?

Current Treatment Approaches for Bladder Cancer

Current Treatment Approaches for Bladder Cancer


Transcript:

Katherine:                  

So, Dr. Gupta, are there emerging approaches for treating bladder cancer that patients should know about?

Dr. Gupta:                  

Yes, absolutely. I would say that the field is so rife with so many different treatment approaches and ways to offer more personalized medicine. We know, for example chemotherapy followed by surgery has been the gold standard, but we have seen data that there are certain genes in some patients’ tumors which may predict how well they will respond and potentially we could avoid a life-changing surgery like cystectomy.

And we have trials with immunotherapy adding to chemotherapy in bladder preservation approaches along with radiation. So, these are some of the new work that’s been done. Approaches to intensify the effect of BCG in newly diagnosed non-muscle invasive bladder cancer patients are also ongoing. Then, in the metastatic setting, we have so many treatment options that have become approved in the last couple of years, now the goal is, well, how to sequence the therapies best for the patient and whether in the front-line therapy we can actually get rid of chemotherapy.

Some of these antibody drug conjugates and immunotherapy combinations are proving to be very effective and the hope is that one day patients may not need chemotherapy because we have chemo-sparing regimens. So, there’s a lot going on and I think the progress has been tremendous in the past few years.                                            

Katherine:                  

Some patients may be fearful when it comes to clinical trials. So, what would you say to someone who might be hesitant to consider participating in one? 

Dr. Gupta:                  

I would say there’s a lot of misconceptions out there that going on a trial is like being a guinea pig or you get a placebo. For the most part, patients are getting active drugs whenever possible. The only time where we have placebo-controlled trials is if, for that particular setting, there is no approved treatment. But I think patients should get all the information from their doctors and the study teams about the pros and cons.

Many times, it’s about – you could do the study because the patients meet the criteria and are fit to do it and if they wait for later, they may not be eligible anymore for whatever reasons.

I always put it this way, that standard of care therapies will still be available, but studies are sometimes with a tight window and tight criteria. So, I think patients should know that all these studies that are out there are very ethical and use the best possible control arm. So that even if they don’t get that experimental drug, they still get what is the standard of care unless it is something really being compared to nothing.    

Understanding Common Bladder Cancer Treatment Side Effects

Understanding Common Bladder Cancer Treatment Side Effects from Patient Empowerment Network on Vimeo.

Dr. Shilpa Gupta of the Cleveland Clinic reviews the most common side effects of bladder cancer therapies.

Dr. Shilpa Gupta is the Director of the Genitourinary Medical Oncology at Taussig Cancer Institute and Co-Leader of the Genitourinary Oncology Program at Cleveland Clinic. Dr. Gupta’s research interests are novel drug development and understanding biomarkers of response and resistance to therapies in bladder cancer. Learn more about Dr. Gupta, here.

See More From The Pro-Active Bladder Cancer Patient Toolkit

Related Programs:

 

The Importance of Patient Self-Advocacy in Bladder Cancer Treatment

What Are Treatment Goals for Bladder Cancer?

What Are Treatment Goals for Bladder Cancer?

Current Treatment Approaches for Bladder Cancer

Current Treatment Approaches for Bladder Cancer


Transcript:

Katherine:                  

I imagine side effects vary among patients. What side effects should someone undergoing treatment be aware of?

Dr. Gupta:                  

Yeah, and that also depends on what kind of treatment they’re getting, Katherine. So, if somebody’s getting chemotherapy, some of the usual chemotherapy related side effects.

Again, it depends on what chemotherapy they are getting, but usually it’s nausea, vomiting, peripheral neuropathy, hair loss, low count, so we try to prevent their counts from going down to prevent infection. If they’re undergoing a local therapy like BCG, they may get irritation in the bladder, something called urinary tract infections can happen, or just an inflammatory state.

Immunotherapy is not as hard as chemotherapy, any day it’s easier but it can cause some rare and infrequent side effects because the immune system can turn against other organs which can sometimes be life threatening or fatal. That could be inflammation of the lung, of the colon, of the different organs in the brain, of the thyroid gland, of muscles, of heart. It can be pretty much anything. We educate the patients accordingly for that.

And, as far as the newer antibody drug conjugates are concerned, they can cause neuropathy or low counts, hair loss. So, every treatment depending on what treatment we’re choosing has a different treatment side – related toxicity profile and we go about reducing or modifying doses as we go along treating the patient.