Have you ever participated in a clinical trial? If so, what was the most important factor in helping you decide to enter the trial?
Yes, I have participated in several clinical trials in my 21 years as a breast cancer survivor (14 years Stage 4). The most important factor was trust in my oncologist to know what is best for me along with my own on-line research.
No. I never was at a point in my cancer that required that I go on a clinical trial.
Yes, through the advice of my diagnosing hematologist. In his words, "I'm not in the habit of passing on patients, but we have one of the top 5 CML researchers in this city. I've already spoken to him and he wants to see you tomorrow. Go and see what you think"
I have participated in two clinical trials, one related to breast cancer prevention and one related to reducing chance of recurrence of breast cancer. I participated in the first one because I am in at high-risk group for breast cancer (strong family history of ovarian cancer). I participated in the second one following surgery, chemo and radiation for triple negative breast cancer.
It would make my Stem Cell Transplant easier.
Yes. I figured that if more people would participate than there would be more knowledge in the cure for cancer.
Yes. As a mets patient, I entered the phase 3 trial to have a chance with a new drug targeted for my specific cancer. Also, I believe in looking out for future patients and hope my participation in a small way will help more people in the future.
Yes because of the possibility that I would get the study drug for a better outcome and closer follow-up; additional testing that I don't have to pay for.
I have never participated in a clinical trial. However I am enrolled in the Trials website and have a profile so that I get notices when a trial matches my profile. I have not found a trial that I qualify for, or that isn't too far away from my home. I work full-time and can't miss that much work due to traveling.
I was glad it was offered. Having small cell lung cancer was a difficult diagnosis knowing little research was available. Hoping that changes!
Yes, I am currently on a trial chemo and have been on it since April of 2013 - 14 months with excellent results and VERY minimal side effects. My oncologist encouraged me to get into this 3rd trial because he knew the drug was having good results with metastatic breast cancer.
Yes, I'm on my clinical trail now. The reason I decided to participate in the trail because I want the best treatment available and to help the research to find the best way to treat cancer for other patients that come after me.
Yes, location and qualify
Yes. Contributing to my own treatment as well as providing new options for others.
Yes. Assurances that the trial drug had shown results as good as the standard of care, and the assurance that I could end my involvement and go to the standard of care treatment if it was not going well.
I have applied for a clinical trial but not yet been accepted because I am at the outer edge of one of the qualifying criteria. They require an additional pre-approval CT scan, which I took this morning. A Medscape video of three oncologists discussing PARP inhibitors laid out the pros and cons for the targeted therapy for BRCA carriers and gave me the information I needed to feel positive about the trial.
I am involved in a phase 1 clinical trial right now. It sounded like a promising treatment for myeloma patients, and maybe even for me. My doctor felt it held more promise than the other few remaining courses of treatment.
I have signed up for several clinical trials but in each case have been turned down because I didn't fit all their criteria for acceptance. I believe in the importance of the trials for discovering better treatment and/or follow-up options.
Yes. To further science and help myself.
No, I've never been able to participate in a clinical trail.
Best option for me.
I had to decide between standard CMF protocol for breast cancer and FAC protocol with 3 arms looking a dose intensity and number of treatments. Since I was 29 I was concerned about which protocol was more likely to affect my fertility. Only after I found a doctor who understood how to conduct a real informed consent discussion, did I understand that it was a particular drug that was the same in both treatments. I come from a family that has participated in clinical research so it made sense to enroll.
No, but I have asked my oncologist to seek one out for me. He is reluctant to "rock the boat" until I have 2-3 years of PCR undetectable results for my CML.
Yes. I participated in a clinical trial for a breast implant when I had reconstruction. The surgeon recommended this particular implant and it was only available through a trial.
What was the biggest challenge or barrier?
Fear of the unknown.
No challenge, no barrier, if you can get the best, it's a no brainer. The clinical trial was with a relatively new drug at that stage; the newsiest of the new, so....
For the first trial, I had to travel from my home (80 miles) many times over the course of my participation. I dropped out when I was diagnosed with breast cancer. The travel was not a big problem for me because I am retired and I had the time and money to travel.
For the second trial I had to leave my original oncologist that I was not happy about, but she agreed it was probably worth it in my circumstance. In fact, my doctor tried to get a trial going in that cancer center. I ended up leaving the trial, because the drug upset my digestive system severely.
Getting it approved by insurance.
Not knowing if you were getting the placebo or the real deal.
The biggest challenge of the trial was the long-term chemotherapy that went along with the targeted therapies. Also the constant testing every 9 weeks is challenging.
The location of where I had to have my treatment; not super convenient, but doable
Finding a trial I qualify for that is close to my home.
I would say none.
The biggest challenge was that it all happened so fast: my prior drug stopped working and at the same appointment when I learned that, I was given all the information about the trial and signed up. When I had time to think about it I got very upset thinking I was going to be on a trial because this was the drug of last resort. I requested an emergency appointment with my oncologist to answer many questions - he was wonderful, spending 45 minutes explaining the trial and answering my questions. It was at that meeting that I learned that I was going to go on it because the trial drug was having good results and as he explained it to me, once the 3rd trial was completed, it could be two years or more before the drug would get FDA approval and I would miss that opportunity for the drug if I didn't take advantage of it now. And so glad I participated - I am having good results. So the challenge there for oncologists and trial/study coordinators is to really communicate why they are suggesting the trial.
The biggest challenge is the side effects of the medication and more blood tests and lab work.
Travel time and expenses.
The additional testing required.
One-third of participants will receive a real placebo.
The biggest barrier for me on all previous trials was that I have an unusual form of multiple myeloma that cannot be tracked by blood tests, so I was excluded from participation from the outset.
I'm always told that I do not qualify. I don't know if it was because I had other medical conditions or not. Sometimes it seemed that they were looking for women who were perfectly healthy except for the breast cancer.
If I didn't have insurance to cover cost when the trial was finished it would have been a waste of time and money of the trial. I also got support with paying for my medication so that was a fabulous help.
Getting real answers during informed consent. The first MD I fired because he just said make a decision. I needed more information to feel comfortable making one so that was the biggest issue.
Getting my oncologist to agree to put me on a dose reduction or dose cessation trial.
Nothing really. The surgeon had to work to find the implant as each site was only given so many. Some of the paperwork things were a pain. The trial paid for a breast MRI every 2 yrs. However, the billing people at the hospital where the MRI was done could never get the billing stuff right and I always had to fight with them over who was paying the bill. There was also a questionnaire I had to complete on how the implant made me feel. Some of the questions were inane.
What surprised you most about your clinical trial experience?
All but one of the clinical trials that I've been on lasted close to a year (or more) before progression.
The extensiveness in terms of other stuff; cardiac monitoring, ultrasounds of leg arteries, the sheer number of vials of blood they wanted. The professor has many PHD students and they all want a piece of me. My personal best is 18 vials in one sitting. So many times in the beginning, two and three times a week, they trashed my veins.
Nothing really surprised me about either trial. For the first trial, the trail doctor and nurses where terrific when I had a bad mammogram and positive biopsy. The contacted the surgeon who took me in and talked to me on the phone several times.
I had an adverse reaction, lost consciousness, and spent the next month in the hospital.
It really didn't change my treatment much. It added another half hour or so to my treatment.
The results. I currently have no evidence of disease. Also that it continues so long. I am 4 years in.
Not being able to find out if I received the study drug or placebo
The more personal relationship between myself, the clinical trial nurse and the entire team of doctors. I felt like I was being followed closer than if I wasn't in the trial. Participating made me feel like I was involved in my treatment plan and helping others.
I was under the impression that trial drugs were measured against placebos. My oncologist and the trial drug coordinator explained right away that I would be selected for the trial or would receive another standard of care chemo. This is a piece of information which really needs to get publicized because I cannot tell you how many people in the chemo infusion center have asked me about the "placebo" arm of the trial.
I can get free medication. My medication is very expensive which save me some money.
It made feel really good to know, that in some small way I was helping.
The placebo effect. Not knowing whether I had the trial drug or placebo did not seem to matter, although I thought I was getting the investigational medicine.
How effective it was and how few side effects I experienced.
So far the urgency has all been on my part.
That the process is both very rigid (protocol timing especially) and very sensitive to my body's response to the medication (and whatever else is going on.) Infusions, scans, labs, etc. have to be on specific days unless some reaction arises (lung problems, sudden rashes, etc.), which can put everything on hold until matters are on an even keel. I have a fantastic oncologist who is in close contact with the trial coordinator, and this may be the main source of this unexpected flexibility.
That is was such a small number of patients joining the trial. I responded so fast to treatment that it was surprising. Had CML.
Communication between study staff was often lacking which resulted in some unfortunate experiences. I know it takes a while to make studies flow smoothly but in retrospect that seemed to take a long time. Additionally, it helps if study staff doesn’t take offense as patients asking difficult questions. These are life and death decisions and we often need more information and time than the staff has available or want to spend.
I got paid to be in the study - $800 on a year with an MRI. That was an unexpected benefit.
What needs to be changed to make clinical trials more patient friendly?
Let us know how other people are doing on the trial to help us make a decision about going on the trial.
I chose not to do a clinical trial for my cervical cancer. The scheduling for trial tests was in the PM hours. The system is not designed to be convenient for the patient. Make the clinical trial part of the treatment.
Just remember that we are people. We are NOT our illness. I had issues with my eyes and issues with my skin [side effects to CML drugs are for many of us EXTREME] but it was me that had to suggest seeing an ophthalmologist and a dermatologist. Both VERY helpful. But my "team" would not have suggested it. Their attitude was, unfortunately, "oh yes, there are these side effects. Some people suffer them worse than others. But at least you're ALIVE, aren't you" Implication I should genuflect every time they pass, instead of complaining about it....
More options for where trials are held would be beneficial. Time and money was not an issue in either trial for me, but they would be a problem for many people.
Have insurance companies comply with trials.
It needs to be eligible to all patients and should be talked about in the beginning of treatment.
I think people (both doctors and patients) just need to be more aware of what is out there.
My clinical trial was handled very professionally and the trial nurse and physician are wonderful; always quick to respond to any need.
Make them available in every comprehensive cancer center, regardless of who/where the principal investigator is.
I would be willing to talk to patients, as I am sure fellow trial participants would.
Have more trials on the West Coast
I cannot think of anything. I was provided with lots of information. Every 3 weeks when I receive chemo, I have the trial coordinator visit with me during my infusion and we complete about 3 questionnaires each time. It takes about 15 minutes out of my chemo time, which is not a problem because I am sitting there anyway.
I don't have any problem with the one I'm on right now. Everyone is so nice & friendly.
More locations, or reimbursement for travel.
Medical centers making patients more aware.
From my experience, nothing.
Our own oncologists need to see clinical trials as their responsibility, both identifying patients who would qualify and benefit and identifying trials that would be particularly appropriate for them. Lost in a sea of clinical trials databases means many of us throw up our hands and say it's too complicated, especially when chemo and radiation have left us with fatigue and less impressive brain function.
If there were some kind of central clearing house, counselors to call who could direct patients who have unusual obstacles to trials where they might be accepted.
I'm on the email list for a breast cancer organization (located in California) and thus receive many notices about open cancer research studies in cities around the country, but rarely are any of the trials available in Dallas, or even in Texas. We need an organization that emails us about research trials available in Dallas. I think it would be a great way to recruit participants. I'm not in cancer treatment anymore, so I don't see fliers announcing open trials.
I think someone needs to be looking at what happens when you have other medical problems besides the cancer.
I had the best support team with both nurses and doctors involved with this trial so it couldn't have been any better.
There is usually a limited timeframe to make a decision, but there needs to be more education before really being able to make an informed decision. As someone who works in clinical research, it is often difficult to make physicians understand that informed consent is a process, not just getting someone to sign a 35 page consent form.
Easy access to new trials such as an update or newsletter on new trials coming up for different diseases.
This trial was fairly easy and it has since ended. But some of the paperwork things were a mess. Part of the problem in my case was this was a community hospital that was not used to participating in large clinical trials like a large university hospital would be. So the billing things were just a mess. Plus not all doctors recommend or know about clinical trials. It would be nice to have a clearinghouse that patients can use to look up trials on their own.