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Brenda Martone: Hello. My name is Brenda Martone and I'm a Nurse Practitioner at Northwestern. Today I'm joined by Clare, who participated in one of our clinical trials. We are going to be discussing clinical trials from a patient's perspective. Hi, Clare.

Clare: Hey Brenda. It's good to see you.

Brenda Martone: It's nice to see you too. Thinking back on when we presented the clinical trial option for you when you were in the clinic, had you heard about clinical trials before that?

Clare: Only just vaguely. I didn't know any details about them at all.

Brenda Martone: When we were talking about a clinical trial and everything that was involved with that, one of the things we had you do was read a consent form.

Clare: Yes, a very long consent form.

Brenda Martone: Did you find the consent form was understandable? Were there questions that still needed to be answered? Or was it overwhelming to actually read? Because you mentioned it was large.

Clare: It was very large. I'm going to guess like 12 pages, maybe more than that. I read it through, literally, several times because I was really concerned about what was going to happen and what was in the information so that I could understand what might be happening to me. Marked a few things in there and asked you guys the next time I saw you. I actually was able to understand enough of it that it made me less nervous about what I was going into.

Brenda Martone: What were you nervous about particularly?

Clare: There was a big section about the drug itself that they were going to be testing and all of the different potential side effects, all of the warnings about talking to the clinical trial people if you're going to get a vaccination or something like that. Considering I had not reacted very well to the chemo when I was doing the chemo before surgery, all of the drug interactions and the possible side effects really interested me a lot.

Brenda Martone: You mentioned that you had a lot of questions and you read the consent. Did you feel that we as clinicians did a good job or an adequate job of explaining what it is that you would expect and answer your questions appropriately? Or did you feel that there were still some things that were unanswered for you?

Clare: No, I actually got answers to everything that I needed. It was enough to reassure me on the points that I was still concerned about. I'm sure I didn't ask all of the questions that were expected. But if they didn't occur to me, I wouldn't have asked them. The information that I got was good.

Brenda Martone: In the clinical trial that you were on, in particular, has a randomization to it, which nobody has control over. It's decided, essentially, by the computer flipping a coin. One of the treatment options was observation, which is what we call the standard of care at this point. The other treatment option was the immune therapy that you had concerns about the side effects. What were your thoughts about having your treatment determined randomly? Did that bother you at all?

Clare: Not really. I was sort of up in the air over which group I wanted to be in. As I said, the chemo did not really agree with me and I was wondering if I get into the clinical trial and I'm in the treatment group if I have problems with the drug, what's going to happen? Are they going to care enough about me that they're going to deal with the issues that I'm having rather than keeping to the protocol? If I'm in the observation group, are they going to basically just watch me for a while and if I have a recurrence, drop me like a hot potato? I was really up in the air.

But the fact that having a computer make the determination actually made it a little bit easier on me because it wasn't based on any information or interactions I'd had with any people.

Brenda Martone: You went through the trial and you were randomized to the observation arm.

Clare: I was.

Brenda Martone: What was your experience? Because you said that you were concerned that if you were randomized that arm, we may drop you or we may not follow you. Have you felt to date, because you're still part of the trial, that you have been followed closely?

Clare: I have been followed very closely. Before I made the decision to enter the trial talking to my oncologist that I'd been through the last several months before that with, I asked his opinion on whether I should do it or not. He was all in favor of the clinical trial. I said, "Well what happens if I'm in the observation group and it comes back?" He said, "Well, in that case, you come back to me and we do the normal course of treatment. But in the meantime, if you're in the trial, there's going to be an awful lot more people paying attention to how you are looking at the scans, checking you over. You're going to get an even better standard of care than I could give you alone." That was a very big determining factor for me. No matter which group I was in, I was going to have the support. It was going to be okay.

Brenda Martone: A lot of patients when they hear clinical trials, at least they've said to me sometimes, that they really don't want to participate, or they're concerned that maybe they're going to be a guinea pig and they don't want to be experimented on. How would you address that concern? Was that a concern of yours? If not, or if it was, let us know. But how would you want to explain that or how would you address that to some other patient who had said, "Hey, I got this option for a clinical trial, but I don't want to be a guinea pig?"

Clare: That's a good question. I think the way I was looking at it was they're testing this to help people in the future who are in the same position I'm in. If it's something where I end up getting experimented on, it is basically for my good and for the good of future patients that there's a good chance that this thing that they're testing out might be what saves me. I really wasn't feeling that experimented on was a really bad thing. I figured there were enough safeguards and enough check-ups along the way that it wasn't going to be some mad scientist in a laboratory, that it was all going to be rather almost standard sort of treatment. So it really didn't bother me that much.

Brenda Martone: From a clinical perspective, from a provider's perspective, we're always looking for ways to improve how we care for patients, both either on and off clinical trials. Is there anything that comes to mind that we as providers could've done differently or better for you during this experience? I know that's a tough question, so you can take a few minutes to think about it. Because that's a loaded question.

Clare: Actually, the only thing that I've had concerns about is during the course of the trial so far. I went from one kind of scan to another kind of scan. It wasn't really explained upfront that there was going to be a change in the protocols. I actually stood at the radiology reception desk with, "I don't think you're supposed to be doing that one." "Well, we'll look at the order." "Okay."

It turned out that it was. I think they actually called down to you guys and got everything verified. That's the only thing that I would say could've been done differently is more information about what specific procedures were going to happen rather than just a generalized, "And you're going to go get a scan now."

Brenda Martone: Which that's very important. That's really good to know. That reduces stress. Then you know exactly what you're doing. I think that's important that everyone is on the same page. I totally agree with you. I'm going to make sure that we at least pay more attention to that and not just assume that things are going to go as they go. Definitely.

Just in general, if you could talk to somebody about clinical trials and sum up what your experience has been or certain things that you would want to share, what sort of parting thoughts would you have?

Clare: This might sound a little weird, but there's a little bit of frustration with the clinical trial in that I know for sure that I'm not going to get immediate feedback on, "Am I helping? Is the drug working? Is the drug not working? What are the results?" I'm a very curious person. So the frustration level of being involved in this, we're going on two years now from my point of view, and not knowing how it's all going to come out is a little bit on the unpleasant side.

Other than that, it's been actually a very supportive situation that I found myself in. I have no complaints about being experimented on or anything. It's been a very positive situation.

Brenda Martone: Would you encourage others if they have an opportunity to participate in clinical trials to keep that as an option open for patients?

Clare: Yes, definitely. I'm all in favor of progress and having new treatments. Without clinical trials, you're not going to have any of that. I think just to benefit everybody, including the individual that's doing it, you've got to have the clinical trials and go for it.