We’ve been hearing from members of the Team of Advisors about how they’ve used the Partnership Principles in their health journeys. Recently, we sat down with John (Dockstoy), living with ALS, and David (Davidgewirtz), who’s living with lung cancer. John and David are both interested in research and have been involved in a few clinical trials. Below, they share their firsthand trial experiences, offer up some advice for others, and talk about the importance of collaboration and mutual respect with their care teams along the way.
Can you tell us a little about the clinical trials you’ve participated in?
John: I took part in trials at:
- Massachusetts General Hospital (September 2014) – phase 2, randomized, double-blind placebo-controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
- Bronx VA – Brain and nerve stimulation for hand muscles in spinal cord injury and ALS
- Weill Medical College of Cornell University – Safety of Capryclic Triglycerides in ALS: A Pilot Study
David: I was diagnosed with stage four metastatic lung cancer just about five years ago. June 2011. Since that time my only form of treatment has been targeted therapies which were available to me through clinical trials. The first clinical trial I received the drug Erlotinib known as Tarceva for three and a half years. The second clinical trial I am now on for about fifteen months targets a mutation that is responsible for resistance to Tarceva. The Clovis pharmaceutical company makes the drug with the code name C01686 which does not have FDA approval and Clovis recently disclosed that the drug has been withdrawn from future development. Both drugs have enabled me to live a very high quality of life and unless told nobody would know I had a terminal disease.
Clinical trials require the patient to be an active participant in the treatment modality. For me both clinical trials required that I have monthly visits to the clinic for blood work and scans every two months. The routine of my CT scans include my chest, abdomen, and pelvis plus a whole body bone scan. Normally I spend six hours at the hospital to compete these tests. That I am monitored very closely is a double edged sword. The downside is the frequency of scans exposes me to significant radiation which overtime is also associated with cancer. There is also generalized anxiety that comes with this routine. When you’re done with one cycle which includes a discussion with the oncologist about the radiology report, you automatically start to think about the next cycle. The silver lining in this cloud is that detection of new disease is caught very early and more often treatable than not – a really good benefit, which takes some of the sting out of the routine.
Have any of the partnership principles helped you get involved in these clinical trials?
John: I believe all principles apply. Respect is key; and alignment and teamwork from both parties involved.
David: “Know your needs” was the principal driver of why I entered a clinical trial. This principle requires that the expectations of the patient (me) are aligned in a partnership with the goals of the oncologist. In my situation there was a shared expectation of the value of clinical trial. In collaboration with my oncologist we discussed the likely benefits, side effects and the efficacy of the trial as a treatment plan for my advanced stage lung cancer. We shared the belief that the benefits of the trial far exceed the risks associated with taking Tarceva. We shared the value that (1) I would receive state-of-the-art treatment with the expectations that the drug Tarceva would (2) not not only control my cancer, but would extend my progression free survival of my disease.
How do you decide if a clinical trial is right for you?
John: Timing is a critical decision factor. What I mean by that is many clinical trials have two-year and three-year exclusion criteria. Also, location — most trials do not reimburse for travel or nominal reimbursement. You must believe that the trial will have a benefit, not only to you but for those to follow.
David: In collaboration with caregivers the patient must know his/her needs in terms of the benefits and risks of entering a clinical trial. This requires that the care team fully explain the benefits of the trial versus the risk of participating. A phase one trial poses the most risk to the patient with an uncertain outcome. In contrast, a phase three trial poses the least. For example, my first clinical trial was a phase three trial where I was given the drug Tarceva with expectation that my medium progression free survival would be 12 months. In my case I did not progress until 3.5 years. Truly a great outcome despite some manageable side effects or risks.
A patient also has the opportunity to enhance the understanding of their disease. All types of clinical data captured in the study helps organizations like PatientsLikeMe market data to pharmaceutical and insurance companies who are stakeholders needed to fast-track new drugs from the bench to the clinic. In the end, your participation along with others may save or prolong the quality of your life. This possibility was the primary driver for me to enroll in another clinical trial that has kept my cancer in check, now five years, with minimal side effects.
What advice do you have for other patients who want to learn more about participating in clinical trials?
John: Research, research, research! Scour the Internet for details, speak with friends and family, ask your doctor what they think and what they see on the horizon for new trials. Be prepared to look at what’s next in clinical trials so as one completes you can start up another.
David: The decision to participate in clinical trials encompasses many of our PatientsLikeMe partnership principles. For example, where you are in your treatments phase may dictate what principles are more important than others. If you are at the start of your treatment, then you must have a very good understanding of what a clinical trial can do for you — how much more quality time the treatment offers. You can only arrive at this decision point if you and your care team have a shared understanding of the benefits of participating in a clinical trial versus pursuing a different line of treatment. Through my experience with clinical trials you are well served if you operate under the assumption that participation is a shared responsibility. Alternatively, if you reach a milestone in your treatment where you must go to another line of treatment then it is critical to reflect, evaluate and reprioritize if your current care team is the right team to meet your needs. Finally, regardless of the phase you enter a clinical trial, you must self-educate yourself
That means you have done some basic research by:
- Reading about relevant clinical trials on sites like the National Cancer Institute, which has a listing and description of all clinical trials in the U.S. and worldwide.
- Preparing yourself for entering a clinical trial by visiting the government website that explains what patients and caregivers should know about participating in clinical trials.
- Participating in organizations like PatientsLikeMe that have communities where patients share their treatment experiences, side effects and their success and failures. Personally, these organizations have empowered me through emotional support and knowledge of other clinical trials that may become options for me while I travel on my journey.
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