Personal Stories

PATIENT PROFILE: My Experience in a Clinical Trial

John Smith

HP: How did you find out about the GM-CSF clinical trial?

JS: I had turned 50 and my primary care physician recommended I have a colonoscopy. I got the results back to find out I had stage I colon cancer and would need to undergo surgery. I had been to another surgeon first, and then decided to go to Columbia for a second opinion. I had visited one of Columbia's colorectal surgeons to find out more information about laparoscopic colorectal surgery, and by chance found out that they were conducting a clinical trial that could help boost my immune system. I didn't go looking for a clinical trial; I went looking for the best doctor for me and I found a clinical trial in the process.

HP: Had you ever participated in a clinical trial before? What was your motivating factor for participating in this trial?

JS: No, I hadn't. Doctors at Columbia carefully explained the trial to me and provided me with very specific literature on the study, so I knew what I was getting into. I was introduced to the research team as well—they were very thorough, which really impressed me. The trial offered me an opportunity to boost my immune system and potentially reduce the tumor recurrence rate. I thought it could be beneficial and wanted to give it a try. I was also aware of the colorectal surgery team's reputation. I had done some research on them. In addition, I realized this could benefit not just me, but other people one day. Although the study was blind to me, because it was randomized, I still wanted to contribute to it.

HP: Did you have any initial fears or concerns about participating in the clinical trial?

JS: Sure, there are always possible side effects that one might be concerned about. But I asked a lot of questions and thought the risks were low. In the end, I definitely thought there were more advantages to the trial than disadvantages. I didn't really see a downside to it. The truth is, I didn't really have any fears around the trial—there were enough other real fears on my mind that dealt with the cancer itself.

HP: In brief, what did the trial entail?

JS: Initially, I had to have some skin tests to see what my baseline immune reaction was. There were three sets of skin tests total—baseline, pre-surgery, and then post-surgery. Basically, the trial entailed receiving injections of the drug GM-CSF before and after surgery, in the hopes of boosting my immune system. And this was done in a very accommodating manner; the research team came to my home before surgery to give me the injections. They did this because it was more convenient for me. They really treated me with care and respect.

HP: Did you experience any side effects or adverse reactions during the trial?

JS: None.

HP: How long did the clinical trial take?

JS: From the time I had the skin tests until the surgery was over, totaled probably three weeks. I am no longer in the trial. Post-surgery there was follow-up for a couple months, but that's it. I have to have a CAT scan and a colonoscopy this summer—a full year after the trial, so we can keep a close eye on things.

HP: What is the status of your health now?

JS: The surgery to remove the tumor went very well. My CAT scan this summer will be able to provide more information. As for the trial, since it was a blind study to me, there is not much I can definitively say. However, I personally believe I got the drug since my post-surgery skin test immune response was so large. I do know it boosted my confidence because I thought my immune system was being boosted. And that helped me maintain a positive attitude throughout the process.

HP: Was the clinical trial a unique experience for you in any way?

JS: It was unique in that it kind of gave me a special status. I feel the trial fostered a stronger doctor-patient relationship in some way. Also, I think the trial shifted the focus from the cancer to something positive—my immune system being boosted. It served as a positive distraction for me, and as an added hope in some form.

HP: What advice would you give to someone who is considering participating in a clinical trial?

JS: I would say really learn what the trial is about first, and ask all the questions you have so that you are more comfortable with your decision. There is a great chance that it might be beneficial to yourself and others—and that makes it well worth investigating and participating in.