comscoreHopeful82014's Story: How to Find a Clinical Trial and Prepare for Participation

Hopeful82014's Story: How to Find a Clinical Trial and Prepare for Participation

In search of a new treatment approach, Hopeful82014 found a clinical trial option and has advocated for herself throughout the process.

Hopeful82014 is a member of the Community.

I started reading and following clinical trials very shortly after my diagnosis both out of curiosity about what advances might be coming and out of concern for my particular situation. My neoadjuvant treatment followed a trial protocol that my surgeon is involved in, although I followed it off trial. I am by nature interested in new approaches, particularly since the standard of care in my situation would have had a negative impact on my quality of life without equivalent benefit.

I had learned of a NeuVax clinical trial for which I met the baseline criteria through the website. There was a participating cancer center in our city so I thought it might be worth investigating after surgery. Unfortunately, the trial closed prior to my surgery. However, the trial coordinator did direct me to another one that was currently open and recruiting, also near at hand. In fact, it is housed in the same facility as my breast surgeon and she is one of the local investigators.

The criteria for this study were narrower but I met them. This trial is investigating the use of Herceptin in combination with either NeuVax or a placebo. It's designed for high-risk women who express small amounts of HER2 and whose haplotype is deemed responsive to both Herceptin and NeuVax.

My surgeon, my MO, the MO from whom I obtained a second opinion, and my radiologist all felt this would be a good option for me and encouraged me to apply. One told me that even if I got the placebo rather than NeuVax she felt treatment with Herceptin could be very helpful and, since I express smaller amounts of it than those considered HER2 positive, this would be the only way I would qualify to receive it.

The first step was speaking by phone with the local trial coordinator to determine baseline eligibility. He then emailed the trial prospectus and the first and second phase consent forms for my review. A week later I met with the coordinator to discuss the trial, the consent forms and go over any questions. At that point a small blood sample was drawn to test for the presence of one or more of the required alleles that would indicate that I might respond to the trial treatments. My medical records were already available to the study, which saved time.

About a week later I received a call from the coordinator informing me that I did indeed have the required alleles and was eligible to continue on to the next step. We discussed the trial protocol again in detail and he went over the timeline for the various tests (blood work and EKG) prior to beginning the trial treatments. I was very pleased to have my eligibility confirmed, particularly since I have a friend who did not have the required alleles and thus can't take part in the trial. Frankly, I felt rather badly that I am able to participate and she is not.

Since the actual trial follows completion of standard of care treatment, I won't begin until after completing radiation. I will need to start within 90 days after the end of radiation, which creates a fairly flexible timeline for me.

Of course, nothing goes smoothly for very long when you're dealing with cancer. Because the trial is facilitated by an institution that is outside of my insurance coverage, it was necessary to apply for an exception. My surgeon's office started that process the day they learned of my eligibility. The insurer recently denied coverage on the grounds of lack of medical necessity and that fact that treatment is considered experimental.

The story doesn't end there, however. My surgeon is appealing the process and hopes for a better outcome on this round. It could take a while to complete as many appeals as it takes and the uncertainty is, of course, stressful and frustrating.

I would be willing to pay for the rather minor expenses not covered by the study sponsor. However, should there be any adverse events that require medical treatment and/or hospitalization those wouldn't be covered and we simply can't afford that risk.

At this time I'm in limbo and hoping to get good news regarding the coverage so that I can count on beginning the actual trial once I complete radiation. The clock is ticking, however, and I'm concerned that I may miss out on what could be a very helpful treatment.

Other than the frustrations created by my insurer I have found the process quite straightforward and comfortable. The coordinator has been very helpful, encouraging and kind and I've learned a lot just through the application process.

If I ultimately enter the trial it will require visits every three weeks for a year, plus additional surveillance for any health issues arising from treatment. After that I will need to make visits for vaccine boosters every six months for two more years, for a total participation of 36 months. Since the study center is conveniently located for me this doesn't present any obstacles. I'll also have a treatment diary in which to notate any side effects, problems, or questions. Of course, it's a time commitment and one never knows how one will react to any given treatment. I realize there may be downsides but from my point of view the potential benefit is greater both for me and for those who may benefit from the research in the long term. I find the prospect of adding to our knowledge base exciting and gratifying.

My recommendations are to ask your doctors about trials, to visit regularly, to follow up on anything of interest and to be both pleasantly persistent and patient when dealing with coordinators and their staffs. Be prepared for disappointment but hope for the best. Talk it over with your significant other or a trusted friend/adviser. If you do participate, approach it with a spirit of inquiry and hope and a sense of being part of something larger. I will add my thanks to all of those whose participation in previous trials has benefited all of us and those who are currently part of a trial.

The opinions expressed in this article are the author's own and do not necessarily represent those of nor are they intended as a substitute for the medical advice of physicians.