Learning and Deciding about Trials

Many people we interviewed told us how they found out about clinical trials and what they considered in deciding whether or not to join one.

Finding Clinical Trials

People we spoke with learned about clinical trials in several ways, including from members of their health care team and from searches on the web. Marquita’s doctor helped her find a clinical trial for multiple sclerosis (MS). David S. learned about a new procedure being tested in trials from a relative and shared it with his health care team. Mia entered her information into an online database: “it's your resume, you know what I mean? Other researchers can go there and find people who are going to qualify for their study." Alejandro said “you have to be very lucky” for someone to tell you about a trial that fits your particular circumstances. Irina tried to join a specific trial, but never heard back from the clinical trial team.

 

A member of Liz’s healthcare team invited her to participate in a clinical trial.

A member of Liz’s healthcare team invited her to participate in a clinical trial.

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Just the neurologist that I see is with the [INSTITUTION] here in [LOCATION], actually, [INSTITUTION], too. So, these are the two main hospitals in our area. Both of them are teaching hospitals. They both have been very involved in and learning and so forth. So, if he's able to be involved in a particular study, then they will work on that. So, it just happened to be that, when I had an issue and was switching over, there happened to be a particular study that I fell into. And so, he would just—after I made the decision, though. So, after I decided to go on the Tecfidera, then it was probably a couple of days later. He called and said, “Hey, we have this study. Would you want to be involved? You fit into it, because you chose this medication. We have the study. We want to go for it.”

 

Jennifer A. speaks about finding out about clinical trials online.

Jennifer A. speaks about finding out about clinical trials online.

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And then, one day, I just found myself on the MS website, and it just had clinical trials. And I think I was actually just looking through to see what new medicines were coming down, and then I realized that they were asking me to do yoga, and do intermittent fasting, and things. And I was like, “Oh, there's clinical trials for just lifestyle changes. I can do that. I can help science and just change my diet or work out more.” I should be doing that anyway, let's be honest. So that's really how I got into it. Just finding it on the MS website and then seeing that the stuff they were asking fit my lifestyle. And then, it's just been all downhill from there. I'm getting involved where I can.

 

Sally says patients need to be proactive to find out about potential trials.

Sally says patients need to be proactive to find out about potential trials.

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And so I don't know how I would have gotten that information otherwise. Yeah, I really don't. Like I said, I see my oncologist once a year, and it's a pretty quick appointment, and I don't- I remember learning about a study. There's a new vaccine for women, you can be as far out as you, whatever. There's no limitations. And there's a new vaccine they're trialing here and in other sites to prevent recurrence, and I only found out about that because I worked, you know, at the Cancer Center for the past year. And I was like, “Whoa, I could be in this study. Why don't I know about this study?” I mean, there's just like this huge disconnect, and I don't know how patients are supposed to get this information. So I mentioned it. I waited until my next oncology appointment, and I mentioned it to her. But because, and she knew about it, but if I hadn't brought it up, you know, she—I think they're just too busy. And some of them are really into research. Some aren't. Some are, I don't know. But it just feels like you really have to look out for yourself unfortunately, because I- I think I have a great oncologist, but you know, you’ve—you kind of, through time, you realize, you really need to be on top of things if you want to know about the latest. And I felt, you know, I get certain emails. I'm part of different groups. But—and so I feel like I'm kind of on top of all this. But then, you know, like, “Well, no, I never heard about that. I didn't know about these new mutations. I didn't know about the vaccine recurrence.” You know, it's just like so much that's out there that you can't, I don't know how patients are supposed to get this information.

Eligibility and Inclusion

Most studies have specific sets of demographic, health, and other characteristics that people must have to be considered for trial participation. Many people felt that it is too hard to qualify to be in a clinical trial. Some people talked about having good luck and feeling good if they “fit the profile” and were invited to participate in a trial. Others said they were denied study participation because they were older, they had more than one health condition, or their disease was too advanced. Rhonda, for example, said some studies “only want newbies.” Amy B. said that the experience of learning that she was not eligible for specific trials was “crushing.” Fred described that he had to stop his usual medication for six months before he could be eligible to join a trial for a different medication.

 

Lisa J. says she isn’t eligible for most clinical trials because of her other health conditions.

Lisa J. says she isn’t eligible for most clinical trials because of her other health conditions.

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Here’s the dirty, little caveat—because I am a breast cancer patient, but I have my co-conditions. So it doesn't make me an ideal candidate, which is a question at every researcher- focused meeting and conference I go to, I'm like, “who's your perfect patient? Somebody's got something else. Where do you find the unicorn?” You know, if you're looking to actively recruit particularly people of color and you have—where there may or may not be a higher rate of co-condition issues, because once you hit a certain age group, then you have that. And you know better than I as a researcher, it's who's your unicorn, perfect patient? It's not me. As soon as you hear lupus or this or that, I'm out. OK. I'm moving along. But, you know, you keep throwing out the line.

So that's- that's the thing. And yeah. It’s—I just don't understand. You know, I mean, I do, because it's been explained a number of times. But that's the criteria. So it’s not that I—I do have certain things that I may not want to do in terms of my medical treatment or interrupt certain aspects or add certain, you know, clinical trial in terms of medication because of the lupus. And that’s—there's not enough information, at least for me, with my co-conditions. But that doesn't take away from other things I wouldn't mind doing. And I just can't to this point.

 

Nikki describes trying to find a clinical trial for which she was eligible.

Nikki describes trying to find a clinical trial for which she was eligible.

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There's a lot of disqualifying — ways to be eliminated. Which was like, “Oh.” It's either you're not sick enough, you're not advanced enough, you're not close enough to death. And I'm like, “What?” This is—it was crazy. I couldn't find one that I could fit in. I mean, obviously, there's gender, age, you know, non-smoker, all those things. I'm like, “OK. Well, these are the easy ones.” But when it came down to it, it’s not advanced enough. Or it's not shutting down enough organs. Or it's not—and I'm like—never actually found one that would work. But again, I trust that's for a reason. So, it's OK. That wasn't meant to be.

Relationship between Trials, Disease and Treatment

Most of the people we interviewed participated in clinical trials while they were undergoing treatment for their health conditions. People spoke about considering their symptoms, health status, current treatment, and prognosis in their decisions about participating in a clinical trial. Several people noted they would not participate in clinical trials if their condition was stable on their usual treatment. Dulce talked about not wanting to switch from her current medication because “at this time, I feel like I'm in a good place. So I don't want to screw that up."

 

Nora says her neurologist recommended against a clinical trial because treatment was working.

Nora says her neurologist recommended against a clinical trial because treatment was working.

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The neurologist had just moved to his new facility, and he always has, in his office, different bulletins of studies. And so, I would always ask him, “What is that about?” And so, I said to him, “Do you think it'd be beneficial for me to go on a clinical trial with other medicine?” And he said, “No because so far, it's working. I wouldn't recommend that. If it wasn't working, then yes, I would recommend a clinical trial with different medication.”

 

Dulce didn’t want to ‘change a thing’ to join a trial, because everything was going well.

Dulce didn’t want to ‘change a thing’ to join a trial, because everything was going well.

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So you mentioned when we talked before that you were offered a clinical trial and decided not to participate. Wondering if there's anything you'd like to say about that decision and sort of how that came to be.

Absolutely. So at this time, and maybe I should have been more open, but I just didn't want to be. At this time, with the exception of whatever happening to me acutely, I'm clinically stable, no evidence of disease activity, got my body pretty figured out overall. I don't want to change a thing. Now, if I can do- ok, worst-case scenario: I have new evidence of disease activity. They probably will not want to change this method at this time. Well, let's see. And they feel about another year. Let's do it.

 

Kelsey talks about not wanting to change from her current medication.

Kelsey talks about not wanting to change from her current medication.

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Well, I think the only way I would consider it was if I did not feel satisfied with my current treatment regimen.

So, if I thought this risk of PML is too high, it makes nervous, I want to try something with a better safety profile, or if I started having relapses and was considering changing my MS medication, I think that would be the point at which I might be recruited to enroll in a clinical trial. But at this point, I'm very happy and very stable on my current MS medication. So, things would have to change pretty dramatically for me to consider going off of it.

Many people we interviewed spoke about when in their treatment process they would consider participating in a trial. After she became “a foodie person,” interested in alternative and complementary treatments for her multiple sclerosis (MS), Amy B. became less interested in clinical trials: "Younger Amy might have been more interested—older Amy probably not so much."

Some people described how their feelings about clinical trials might change in the future if they experienced declines in their health, their current treatment stopped working, or they didn’t have other treatment options available. Susan similarly noted she might consider a trial, “if [her] MS would have been really, really bad.” Dulce said she might make that choice “if I continue to have breakthrough lesions.” Several parents said if their children were doing well with current cancer treatments they would say “no thank you” to clinical trials, but as Danielle put it, if the child was “really struggling—I would have said give it to me, where do I sign." Ann and Liz would consider participating in clinical trials if they didn’t have other options for treatment.

 

Nikki says her openness to clinical trials depends on her current treatment options.

Nikki says her openness to clinical trials depends on her current treatment options.

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Mhm. OK. So, would you be open to a clinical trial if one came along that fit—you fit the bill for?

It would depend. You know. I guess getting treatment now feels a little different than the first time when it was—again I think I'm still, let's do everything we can. But knowing when you can disrupt this and knowing I have a set amount. I only have two options left right now. Like if we go off of one, you don't go back to it. So, it feels a little bit different. Like I think I need to be a little bit more calculated with if I make a switch. But things are going, and they're steady right now. I don't know. I think that I would probably stay right now where I am. Like things are steady, and it's—it’s working. We know it's only for a set amount of time, apparently. But I think I might ride that wave at this point, you know? And what's working, was going to work. So, not to say I wouldn't, but I guess when you have limited options, you're like, “We'll think pretty hard about this.”

 

Linda talks about how participating in a trial now could help her if she has a cancer reoccurrence.

Linda talks about how participating in a trial now could help her if she has a cancer reoccurrence.

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And but I have not, at this point in time I have not needed a clinical trial. But I have, like I said, I wanted to participate because I felt this was important on down the road, if I were to ever have a recurrence. I felt that it would have been important for me to try to help in that development of a very targeted drug.

Timing of the Decision

Several people noted that when they were asked about a trial mattered a lot. People talked about it being difficult to think about participating in a trial when healthcare teams brought up trials right after diagnosis when, as Jennifer put it, she “just didn’t even want to try to incorporate the possibility of something else.” Maria was not even sure what her son’s diagnosis was when she was invited to participate in a clinical trial. Some people felt they had to make a quick decision when they were offered participation in a clinical trial. Ashley felt she had to make decisions “quicker than necessary,” with only a week to mentally process her son’s cancer diagnosis and a few hours to decide about treatment options and clinical trial participation.

 

Cristy says it’s hard to make decisions about clinical trials when new to pediatric cancer.

Cristy says it’s hard to make decisions about clinical trials when new to pediatric cancer.

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What do you feel in general about that, sort of, idea of being part of a study or a clinical trial?

I think it's interesting. Because if you don't know a lot, and you're completely new to that world, as most parents are, when you hear the word study. You think, "If I'm in it, am I going to get something different?" Or, “is my child going to get a different treatment than if I'm not in it?” Again, I think there is that feeling, like you have to make that decision right away. But, you can always pull out, which I think is helpful to know.

 

JanLynn could not process the idea of a clinical trial during her first meeting with a surgeon.

JanLynn could not process the idea of a clinical trial during her first meeting with a surgeon.

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Were you asked to be involved in any clinical trials?

I was asked. So, you’re asked, not you. But I was asked in the very first meeting with the surgeon. And I did not consent because I couldn't process what was happening to me in the first place. I was unwilling.

Getting Help Deciding

People in our study came to decisions about whether to participate in several ways. Some talked with others who had also been offered a place in the same trial. Others turned to spouses, friends, other family members, or health care providers for support and discussion. Liz spoke with her sister who had been in a trial and was supportive. Jim trusted his neurologist and didn’t discuss his decision with many other people. Bianca’s husband wanted her to do whatever she and her doctor thought was right.

 

Sally says she couldn’t make a decision and asked her husband to help.

Sally says she couldn’t make a decision and asked her husband to help.

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I couldn't eat for three days, but then I was fine until my next round, and I did decide to go with a clinical trial. Which, you know, that was kind of interesting, too, because I really thought I would be much more involved in the decision making, but I- I really couldn't. I- I just couldn't deal with it. And so luckily, my husband, I said, “Research this clinical trial. Tell me what you think.” Because I cannot make a decision. And that's really unlike me. I was shocked that that's how I was reacting. And, so he looked it all up.

And I just look back and think of that as an interesting piece, because I just, I couldn't, I couldn’t, I now get why people just can't make any decisions. They can't function. And you feel like, “Wow,” you know, “Don't you want to participate in your care?” and it's like well, you're not in any emotional state to do it. At least I wasn't.

Trust in Doctors is Important for Decision Making

People’s connections with their doctors were relevant to their likely trial participation. Jim was the first participant in his neurologist’s trial; he had confidence in the trial because his neurologist was “the main guy.” Mercedes said having a strong connection and rapport with her neurologist made her want to participate in her neurologist’s trial. Several participants described how it took little more than their doctor mentioning a trial for them to be willing to participate.

 

Julia describes how her trust in her doctor makes her open to try a trial.

Julia describes how her trust in her doctor makes her open to try a trial.

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One benefit for me right now is that unlike the first doctor that I saw here, I completely trust my doctor. So, if he tells me that it's safe to try, but if he said that it's not likely this it will do much difference, but he says it's safe try, and I should go ahead if I want to.

 

Sally says her trust in her oncologist made her stick with a decision to participate.

Sally says her trust in her oncologist made her stick with a decision to participate.

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So of course, we go in, and they pulled, you know, the third option, which is, we said, “OK, now we're backing out,” and they were like, “wait a minute.” I said, “We can back out at any time.” But then my oncologist came in, and she said that she thought it was a really good option for me, and I- I trusted her. By that point, we'd had, had enough conversations, and I just said, “What can I do, but trust you?” You know, so we did it, because she said, “You take two drugs at once. You hit it really hard right away. It's really intense. But you're done in four rounds.” And so I did it.