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A video interview between Terry Evans, CLL patient and Sheila Hoff, RN, Clinical Trial Nurse at the University of California, San Diego, Moores Cancer Center. (See video at the bottom of the page)
Terry Evans: What is the role of a clinical trial nurse? What are your responsibilities?
Sheila Hoff: The role of the clinical trial nurse, similar to the role of a nurse, is patient education. Specifically, we educate people about the clinical trial. The doctor is the expert in what the clinical trial is about, but the nurse can supplement that and spend a little more time talking about the potential side effects of the study.
There is always the option of not doing a clinical trial and going on the standard of care. So after the doctor has introduced the study, I usually have a conversation with the patient afterwards to help them go over the pros and cons of the various scenarios. Although we would like to support and would like to offer clinical trials to everybody, sometimes clinical trials are not for everybody. The travel, the amount of visits they have to do. It just might not fit into their lifestyle, or they live so far away and they can’t afford to come here and stay. There are a lot of different things, as well as just explaining the potential side effects that the drugs are expected to cause.
TE: When I participated in a clinical trial, (I participated in 2) the documents they gave me to sign were very lengthy. You can tell that a lot of work went into putting those documents together that specify your commitment and the side effects and the potential outcomes that they are looking for when they put the trial together.
Is that the document that you go over with the patient?
SH: I actually don’t go over each document. Each trial at our facility also has a study coordinator and they are responsible for going over the exact information, i.e., on Day 1 you do this, on Day 8 you do this. They go over the specifics of the trial.
I try to do more of an overview of it. I’m more involved in the decision-making beforehand. Many times we’re talking about more than one study. We have a number of possible options for patients to go through and that’s the part that I feel like I can help out with. I can help people look at the pros and cons of each of the studies and compare them to each other and what things might impact them. I’m fortunate that I get to know the patient a little bit and sometimes I can anticipate, for example, this particular trial requires a lot of travel and I know you live in northern California, so that might not work out for you. Or some of the trial medications are oral, so we talk about some of the potential side effects when taking oral medications at home versus IV medications administered in the clinic. So I try to review that with each individual.
TE: Before the first clinical trial that I was in, I was offered 3 different clinical trials. We worked back and forth between Dr. Kipps and you and my wife. We went over the pros and cons of those trials to try to figure out which one would fit me, not only in terms of the time commitment, because some of the trials require hospital stays, some require a major time commitment. If you’re working, it’s very difficult sometimes to coordinate all that.
What do you think is the real advantage to a person entering into a clinical trial?
SH: There are many advantages to clinical trials. The first one is the ability to access drugs that you would not have the ability to get in a regular oncologist’s office. As you know, you started on a drug before it was commercially available, so that allowed you access to that drug. When a drug is given in a study, and it’s not available commercially, it’s provided by the company or by the study so that is a cost advantage for people who may have big copays for some drugs they take. Those are all very practical for individual patients. On a more global level, we can finally know what the best treatment is. So many time people ask, ‘Which one is the best?’, and I tell them, ‘If we knew that, we would definitely let you know. We just don’t know that answer.’ The only way to answer that question is to have more people participate in clinical trials. That way we can answer the question about which treatment is best in CLL. It’s confounded more recently because we have so many new drugs being developed. One of the ways that a clinical trial shows one drug is superior to another is to compare it to the standard of care. Right now, we have so many drugs that it’s hard to know what is the standard of care. A lot of doctors and companies are now doing studies looking at sequencing, for example, should you do the hard core chemotherapy first, then the BTK inhibitor, then something else. So it’s a lot about in what order to give the treatments, as well as which are best in terms of clinical response.
TE: I know in clinical trials, not all of the costs of the trial may be covered by the company that is doing it. I know that there is also concern about the extra tests that are sometimes required, like CT scans. Do you think that this model is going to change in the future, or do you think they are still going to require multiple CT scans to see your progression on the drug?
SH: That’s a very, very good question. I think that it will probably stay the same. The reason is because one of the ways we follow CLL, besides blood counts, is the size of the lymph nodes. There are a lot of CLL physicians who do a lot of lymph node exams and consistently over time they can tell if the nodes are getting bigger or smaller. When you’re looking at doing a clinical trial with many different sites, many different physicians and with many different abilities to do a consistent lymph node exam, the companies have found that they need to do CT scans. It is the only way they can have confidence in the data over time. I don’t foresee that stopping within clinical trials. Not that we should do it just because of this, but it actually mirrors what is done with trials for solid tumors (colon cancer, breast cancer, lung cancer). They do CT scans every 2 months to follow the response to treatment. For those cancers, the tumors are inside. There are no palpable nodes and there’s no blood work to follow, so most of those cancers are followed by serial CT scans. That’s why they do it in CLL because there is a model of doing it in solid tumors. Depending on which side of the fence you sit on in that argument, I don’t foresee that going away in the near future.
TE: When someone is going to enter into a clinical trial, anticipation of the first day and how I’m going to react was an issue. For me, anticipation was much worse than the actual treatment. How do you deal with patients and calm them down?
SH: That’s a very common occurrence. The best way I have found to help is just to educate the patient by talking to them about what may happen and what the possibilities are. It is a big event. There are a lot of unknowns. I think all of us realize that the anticipation is almost always worse than the actual event. Education is key. If it’s related to a study, I try and let people know how other patients that we have treated at our site have done. We talk about that because those consent forms can be overwhelming. It is required that every known possible event is listed, whether it’s common or uncommon. When we go over those consents, I try to help the patient understand which ones are the most common, that they are likely to see or that they will see. I’ll tell them, “You will see this no matter what. Everyone has had this happen.” It’s helpful if you know what’s going to happen, then you’re not afraid if it’s going to happen, so then there’s a little less anticipation of it. Sometimes if people are still very fearful, I’ll try to connect them with someone who has already gone through the clinical trial. I can say that, “I’ve not walked in your shoes.” It’s better to talk to someone who has done it.
TE: Are there any closing thoughts that you might have for patients that are considering clinical trials and maybe what to look for or how to ask their doctor about how to get into a clinical trial?
SH: That’s a very good question. Nationally, there are very few patients who go on clinical trials. Just the idea that the patient is interested in a clinical trial is great. There is the www.clinicaltrials.gov website which is a national registry that lists all clinical trials. They are usually in bigger cancer centers and sometimes it’s difficult for patients to get to, but that’s the way to access them. Also, just asking their doctors about it is a way to find out about trials. We have a number of patients even in San Diego which is close to an academic medical center. We’ll have a community oncologist refer a patient because the patient asked. The patient looked up the clinical trials and said “I want to do this one. I want you to get me into it.” Kudos to the patient for being their own advocate and for wanting to participate.
TE: Thank you very much for your insights on clinical trials and continue the good work. It’s affected me personally and I certainly appreciate it.
Sheila Hoff, RN – Clinical Trials Nurse
Sheila Hoff, RN, BSN is the research nurse for Dr. Thomas Kipps, MD and has been working with CLL patients for the last 9 years at the Moores UCSD Cancer Center in La Jolla, CA.
Terry Evans – CLL Patient
In June, 2000, through a routine blood test I was diagnosed with Chronic Lymphocytic Leukemia. I was watch and wait for over seven years. During this time I had blood tests every six months, and check-ups by a very qualified local hematologist to make sure I didn’t have any other ‘B’ symptoms like swollen lymph nodes, night sweats, fatigue or weight loss. During those seven years I had minimal symptoms and the major issue was my increasing white blood count (WBC), which by September 2007 had increased to over 600,000. People with poor prognostic markers, like 11q deleted 17p, ZAP 70 positive, and unmutated have a much poorer prognosis. I have ALL of these makers and here I still am. Based on OLD statistics I had about 5-7 years of life left when I was diagnosed in 2000. Now, 14 years later I am still going strong, and expect to be here another 14.
Originally published in The CLL Tribune Q4 2015.