by Dawn Yun
It’s been almost a year since I was diagnosed with a rare cancer and began a clinical trial.
Both seem surreal.
I went with a friend to a highly regarded hospital to see Dr. Ryan,* one of the nation’s top authorities for this cancer.
It was an eight-hour diagnosis of long waits and short body inspections. At the end “the team” of doctors concluded I had Stage 1 Mycosis Fungoides, or Cutaneous T-Cell Lymphoma, an unusual, inoperable, and chronic cancer that begins in the lymph system and manifests on the skin. Annually it affects about 1,000 people nationwide.
Immediately after my diagnosis, a half circle of doctors surrounded me and asked me if I would participate in an upcoming clinical trial with a topical chemotherapy drug. It was already a treatment being used off-label for this cancer, but because the FDA had not approved it for this use, insurance companies rarely covered it. The drug manufacturer charged $500 to $700 per tube.
I would be seeing a top specialist, help others by getting the drug approved, and receive the drug for free.
I said yes.
I was given information about the disease and a consent form to read and sign, and asked to come back in two weeks. When I returned I was told that two more confirmation biopsies were needed before I could begin.
This is an embarrassing disease. Rashes, that are called tumors, are on my behind, back, stomach, breasts, and thighs. The young doctor/coordinator of the study took biopsies from my stomach and rear.
In the study I would randomly receive the drug in one of two forms: a very greasy ointment or a less oily one. I was to apply it every day and see my doctors once a month for 12 months and then every three months for the next six months.
The biopsies came back positive, and a few weeks later I brought my best friend, Amy, with me for my first appointment.
I sat in my thin, worn hospital gown while six to eight medical staffers stood in the small room. Dr. Ryan entered and told Amy she had to leave.
I was then asked to stand and remove my clothes, and the doctors picked three areas on my body to follow for the length of the study.
I felt humiliated as I stood naked while everyone stared, touched, measured, and discussed—me. I did not like this at all.
I was asked if I wanted to put the medication over my entire body or just on the places that had cancer. I said the latter.
I was shown how to apply the medicine. The appointment lasted two hours. Then my blood was drawn four times over the next six hours.
Other than being toxic, they said the medication didn’t really have any side effects. I was to apply it nightly and wait five minutes before getting dressed.
I quickly learned that there was no way that it would absorb into my skin in five minutes or even ten. My pajamas stuck to my body. The medicine also had an unpleasant chemical smell to it. Sometimes it burned and tingled when applied. It made my skin redder and itchy, hallmarks of the disease.
I learned from the Internet that, sometimes, if you apply the drug over your entire body, it can bring cancer out in areas where tumors hadn’t been found. I decided at my next appointment I would tell Dr. Ryan I was ready to put the medication over my entire body. If there was more cancer, I wanted to know.
At my next visit, I learned that the original doctor/coordinator had left for a fellowship at another hospital and had been replaced by a part-time college student studying to be a doctor’s assistant. At first I thought she was a doctor and told her about my decision to begin using the medication all over my body. She said the rules of the study forbade changing medication doses. I never brought it up again.
Dr. Ryan and her team came in and asked me to remove my gown. They instructed me to stand in front of a light blue blanket while they photographed my naked body. I felt like a prisoner. There were close-ups and long shots of my behind, then the front of my body. I stared off into middle distances that were never far enough away.
Dr. Ryan inspected the three areas they were to follow. Then they measured, assigned numbers, and had conversations about my body.
It was bizarre.
Still, I felt fortunate to have an expert of Dr. Ryan’s stature as my doctor. I could see she was concerned, and I was getting great care.
Putting the medication on nightly and getting naked and photographed monthly became my world. My universe soon developed into one of anxiety and panic attacks.
It was hard for me to write, which is my job, take care of my family, and also deal with this third element—the clinical trial.
I asked Dr. Ryan if she would continue to be my doctor at the end of the study.
“Only if you’ll have us,” she said sweetly. Dr. Ryan explained that many people who are patients enter a study, return to being patients, then become study subjects again.
Suddenly, I realized that I was simply a number to them. I could barely get through each day because all I could do was obsess about the trial. I began seeing a psychiatrist monthly just to discuss the study. Not cancer, not other physical problems, not my personal situation—just the study. These doctors cared about statistics, not my emotions.
On the Web I found a site that perfectly summed up my feelings. It said that the mistake people make when signing up for a clinical trial is they think they’re getting a medical patient appointment. Instead, they’re getting a research subject appointment.
And they are two very different things.
For three months Dr. Ryan disappeared and left the study in the hands of a young, far less experienced physician who was on a lymphoma fellowship. Dr. Ryan returned only after I repeatedly asked that she do so. Her visits were very quick.
I felt that the clinical trial I had signed up for was no longer the one I was in.
In the tenth month of an 18-month trial, I seriously doubted whether I would continue and made arrangements to see another specialist at a different hospital.
I want to be a patient, not a subject. That said, I believe clinical studies are important and people should be in them. You can help yourself and others. But you should know what you’re getting into when you agree to participate in a medical trial so you don’t feel like you’re on trial.
- Ask to speak to others who have been in trials so you will know what to expect.
- Carefully read the consent form for your trial. If there is anything you don’t understand, ask. If you still don’t understand, ask again and again until you do.
- Ask if medical doses can be changed during the study. For example, you may find a medicine is working but causing an irritation, and using it every other day rather than every day might be better.
- Know how much time will be required of you. Find out how often you will have to see your doctors, pick up medication, or have procedures.
- Know who will be your main trial caregiver throughout the study. I signed up because of Dr. Ryan, who was a specialist, only to find that once I was in the trial, it would be turned over to a less experienced doctor. If I had known that, I would not have participated.
- Find out if you can bring a friend or family member to your initial and subsequent visits. Having someone familiar in the room can make appointments less stressful, plus they can take notes for you.
- Don’t be afraid to e-mail or call your trial doctor whenever you have a question. Don’t feel you are imposing. It’s important that you get immediate answers so you don’t have needless worries.
- During a trial, if a health concern develops in another area of your body that has nothing to do with the trial, such as a gastronomic pain, and your trial is to test a lymphoma drug, do tell your clinical trial doctor about it, but do not expect her to have an answer to its cause. She may well refer you to a gastroenterologist to figure it out. Her concentration and funding is on the lymphoma trial, not your stomach pains. Of course, there might be a connection between the drug you are taking and stomach pains. In my case there was not, and I was told to see a gastroenterologist.
- Notice how your trial doctor interprets your information. Is she interested in what you’re learning about the trial medication you’re taking or how you’re doing after a procedure was performed? If she seems not to care, that’s a red flag. A trial doctor should be very interested in hearing your experiences. That should be an important part of any trial, not just pushing approval of a medicine or procedure.
- A clinical study can be emotional. You’re dealing with your disease and you’re being inspected. You’re under a microscope. Consider getting therapy to talk about your health and trial experiences.
- Know all the side effects of a medication or procedure. Trial consent form language can be vague, so ask doctors for specifics.
- If a trial doctor wants to perform a procedure that you’re uncomfortable with, say NO. In my case, I did not want to have another biopsy taken. I agreed because I thought I had to do it to continue in the trial. I later learned the biopsy wasn’t necessary.
- Don’t feel that you don’t have a voice during a medical trial just because you are receiving medical care and medications for free. You may not be paying for your visits, but your participation is your currency.
- If being in the study becomes too overwhelming, consider dropping out. Don’t feel bad if you do. You may think you’re letting the doctors down, as well as other patients who would benefit from the FDA’s approval of the drug you’re taking. Remember, before you can help others, you have to take care of yourself. Don’t feel you didn’t help. You did. A study takes into account that some people will not continue. Information from your participation will be used even if you drop out early.
Dawn Yun is a journalist, author, and speaker based in San Rafael, California. Her work has been featured in USA Today, USA Weekend, and the San Francisco Chronicle, and on NPR. She writes and speaks on medical issues from the patient’s perspective. She is also the founder of Writing Mamas Salon (www.writingmamas.com), a writing group for mothers with chapters nationwide.