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Alicia Morgans: Hi. I am delighted to have here with me today, Brenda Martone, a nurse practitioner in medical oncology at Northwestern University and a wonderful colleague of mine. I am thrilled to talk with you today Brenda about clinical trials and how we think about those, how you think about clinical trials and how we help patients overcome barriers to get them into clinical trials, to answer some of the questions that we need to answer to take the best care of people that we can. So you've been in this business for a long time. You've been an oncology nurse practitioner for a long time and you've seen many clinical trials over time. What are your thoughts and how do you think about introducing a clinical trial to patients that you see in the clinic? 

Brenda Martone: What I'm finding or what I have found is a lot of patients, even though clinical trials is sort of the foundation of our practice, a lot of patients are kind of unfamiliar with clinical trials and some of their preconceived or misconceptions that they have about clinical trials in terms of it's only for at the end of cancer when there's nothing else that's available or it's all experimental and we're not going to know what I'm getting or I'm going to get a placebo, how can I get a sugar pill? I think when we present information to patients about clinical trials, it's important to explain things and kind of review what the study involves, and if there is randomization, letting them know what that means, and that we don't have a choice about what treatment arm is going to be decided. It's random.

If there is an arm where there's observation or a placebo, it would be appropriate to explain why it's okay in this situation because those things aren't always okay in every single disease state or stage of disease. Also, I think it's important to reassure patients that this is a decision that they can make. They can say no and it won't affect their care and nobody is forcing them to do the clinical trial. If they start a clinical trial and they're concerned about what's going on or they find that it's becoming too cumbersome or they just don't want to participate anymore, they can withdraw at any time. It's not a contract where you're signing and you can't say no.

Alicia Morgans: Absolutely.

Brenda Martone: It's more it's an agreement. I think just understanding and listening and asking the patient what their kind of beliefs are and what they feel a clinical trial would be or how they view that and what define it helps guide our conversations in terms of dispelling some of those myths and making them feel comfortable. Most often in the clinic, clinical trials are introduced as well as standard of care and standard of care came about because of clinical trials. So most times patients have options. So if they have an option for a clinical trial, we like to give them that opportunity to see something perhaps new, unique or novel as well as the standard of care so they can make a decision in terms of treatment. So they're aware of all their options. 

Alicia Morgans: Let's go through some of these one by one because you brought up some great points about things that patients may believe or think about that might not necessarily be exactly the way things are. So the first thing you mentioned is that clinical trials might only be for the end of life, that I would not do a clinical trial if I had early-stage disease. I think it's really important and something we don't necessarily always think about that sometimes clinical trials happen in prostate cancer, for example, in active surveillance or in biochemical recurrence, which are two states where patients probably have years and years and years left to go, and in the active surveillance setting, they may actually never get definitive surgery or radiation for their cancer. But studies need to be done at all stages of cancer to really understand how to best care for that particular type of person. So not even close to the end of their cancer journey. I'm sure that you've participated in some of those types of studies as well. 

Brenda Martone: Absolutely. It's those studies also, in one way to look at it, even patients who are biochemical recurrence or in active surveillance, we can gather data from those patients and we can help tease out who may be at increased risk for cancer recurrence and maybe figure out certain risk factors when we're looking at a patient in real time that would help us decide treatment options for other patients in the future. Observation and surveillance are active treatments and we're gathering data and all of that actually comes in, becomes very important. It helps us drive future decisions. 

Alicia Morgans: Yes. You know what's also really important for patients to know is that no matter what the protocol says, the doctors and the nurses and the nurse practitioners who are taking care of them do what's right for that particular person. So even if the protocol says you only get a scan if X is happening, if something's happening where the doctor thinks that there needs to be a scan, we get a scan.

Brenda Martone: Absolutely. 

Alicia Morgans: We definitely do not withhold any standard imaging, lab tests or other treatments when we're trying to take care of a person because our number one goal is to take care of the person and it's really an opportunity to learn more and to potentially give them access to other treatments, and that's the reason for the trial, but certainly not to withhold or to not make sure that they're well taken care of. 

Brenda Martone: Exactly. Oftentimes in clinical trials, the frequency of testing, not just saying for everything, but sometimes that frequency of testing can be a little bit more often. Sometimes the visits can be a little bit more often, but patients are watched very closely. So if there is a change or something is happening, just as you mentioned, we act as clinicians first and patient safety care is first also. So regardless of what the clinical trial says to do at that time, clinical judgment trumps everything in patient care. 

Alicia Morgans: Yeah, and you bring up a great point too that often patients who are on clinical trials have closer monitoring both in the clinic with scans, with lab work and actually often phone calls from the research coordinators or research nurses and they have a hotline to those research coordinators or nurses so there is often a dialog, sometimes even several times a week depending on what that patient is going through, that is a clear and rapid dialogue that can actually be more effective or at least more often than patients who are on routine care and who have to call and then get a call back the next day. So there is such attention to that individual that even if they're on standard therapies or a control arm in a clinical trial, often they'll do better than people who are getting that treatment who are not on a clinical trial. 

Brenda Martone: Obviously, we work together and our study coordinators are fabulous and our patients, all of our study patients love the study coordinators. 

Alicia Morgans: Yes. 

Brenda Martone: I actually have to agree, the contact is increased. I think sometimes patients don't know when to call or they don't want to call or they don't want to bother. But I think if we reach out to them because we're doing a conversation or a followup question based on the trial, sometimes I think that gives them permission to bring things up that they may not have said to us. It kind of depends on who they're talking to also. Sometimes they don't want to bother you or I, but the study coordinator, they'll mention something and then that coordinator comes and talks to us and then we're able to intervene or help that patient out. 

Alicia Morgans: Agreed. Agreed. The other thing that I really want to make sure we touch on is the fear that people will get placebo or a sugar pill. I think one of the most important things that I talk to patients about with clinical trials is that in most cases patients at least get what we think of as standard of care. So whatever the best treatment is for them at that time is usually what they get and then half the people, if it's a randomized trial, which means that a coin is flipped essentially and patient A gets this treatment and patient B gets this treatment, everybody typically gets that standard treatment and then the coin is flipped and then maybe only patient B gets an extra treatment. So it's all best treatment, to begin with and then extra treatment in one of the treatment arms, which means that for those patients in the trial, they are getting what we believe is the best standard treatment for them and we're taking really good care of them. There isn't a sugar pill in the sense that nobody's getting absolutely nothing. 

Brenda Martone: Right.

Alicia Morgans: So that's really important. It's also ethical that we take care of people and we would never ever open a trial where there wasn't that care for people. 

Brenda Martone: Right. Oftentimes too when I talk to patients, nobody knows the future. We do have the standard of care, we understand how that works and the side effects. But what we're looking at is sometimes that extra treatment, maybe we're familiar with in another setting or using as a single agent or maybe not. But I think it's important that I always tell people that sometimes more isn't always better. Sometimes it's just more.

Alicia Morgans: Yes.

Brenda Martone: But that's how we gather more information. But just to kind of put it in perspective, reassuring them they are being cared for at the best level that we know and then there is that potential that more could be added but we are unsure of what that more is going to kind of play out and that's why we're doing the trial. 

Alicia Morgans: Absolutely. If we knew the answer, we wouldn't have to do the trial. You bring up a great point. So there's going to be a trial presented at ASCO, which is a large cooperative group trial by the Alliance Cooperative Group, so a National Cancer Institute-funded large phase three trial that looked at two drugs versus one drug, Abiraterone and Enzalutamide versus Enzalutamide alone in metastatic castration resistant prostate cancer. They found that the combination is not actually better than one drug on its own. So those patients were potentially getting extra toxicity but not necessarily getting extra benefit. If we made the assumption that the combination was going to be better and never did the trial, then we wouldn't actually know the answer.

Brenda Martone: Right.

Alicia Morgans: These are really important things for us to figure out. I would say there are some settings where observation is the best standard of care. So there are some trials where particularly in settings where you've done a surgery and you have no sign of active cancer, for example, the standard management is to use scans and blood work and doctor and nurse practitioner visits and follow people over time and start treatment if the cancer comes back. So one arm might be looking at that and the other arm of that clinical trial could be adding a medicine so that there's not really a sugar pill, but one group is not getting an active treatment. But what's important in that situation, both of these groups are getting monitored closely. Only one group is getting extra treatment. We don't know that it's better to get that extra treatment at that time right after the operation or if it's just as effective to get that extra treatment when the disease starts growing again. So there are times when we don't give active treatments, but they're very well thought out and it's because these questions haven't yet been answered.

Brenda Martone: That's like the beauty of clinical trials.

Alicia Morgans: Yes.

Brenda Martone: I mean, the questions get answered. The data is there and we can make sound decisions for our patients.

Alicia Morgans: Take care of them the whole way through. 

Brenda Martone: Oh, absolutely. I agree. Yeah.

Alicia Morgans: Absolutely. So thank you so much for talking with me about this. I'm hopeful that patients and physicians will get something out of this and hopefully we can get everybody who is willing on clinical trials so we can answer some of the big questions that are outstanding in GU Oncology. So thank you so much. 

Brenda Martone: You're welcome. Thank you.