FORCE has a strong commitment to promoting research to benefit our community. We advocate for more research funding, educate people about available studies, and report findings back to our community.
by Lisa Rezende, PhD
Patients rightly demand better options for themselves and their families. Research is critical for discovering new ways to find, prevent, and treat hereditary cancers—the path from a great idea to an approved method of prevention, screening, or treatment involves years of research. The final steps on that path are clinical research studies or clinical trials that require patient participation. As part of our new Project IMPACT (Implementing a Patient-centered Approach to Clinical Trials) supported by a Celgene Innovation Impact Award, FORCE asked our community what influenced their decisions to participate in clinical trials. Here we present the first part of our survey results.
Our survey was open from June 1 through September 8, 2016. It was advertised through FORCE social media and email list, and promoted by other advocacy groups. Over 1,700 people responded to the survey. Of those, 1,180 people completed the survey. Respondents were overwhelmingly female (98%), with most (59%) between the ages of 45 and 64. Of those who answered questions on their health history, 87% had a mutation in a gene that increased cancer risk and 59% had been diagnosed with cancer.
percentage of people reporting mutations
percentage of people reporting cancer diagnosis
The survey was open to people who had both participated in clinical research and those who had not. Based on their history of cancer or presence of an inherited mutation, most respondents would qualify for a clinical research study. We found that while many (42%) respondents had participated in clinical research, the majority (58%) had not.
percentage of people who had vs. had not participated in research
Respondents reported participating in a variety of different types of clinical research studies, including disease treatment, prevention, and detection, as well as research registries, quality of life studies, family history studies, and donating tissue/tumor banks.
types of people research studies that respondents participated in
We asked those who participated in research how they heard about the study. The graph below compares the responses of people who have participated in disease prevention research (blue) to those who have participated in treatment research (pink), and then compares those to all respondents (purple). It is clear that most people reported hearing about clinical research studies from their doctors. This was particularly notable for people who participated in treatment studies; 80% of these respondents reported hearing about the study from their doctors.
how people learned about the research they participated in
Many respondents participated in more than one study and/or heard about the same study from multiple sources, so the numbers above exceed 100%.
People participate in research for a number of reasons. We asked individuals who participated in at least one clinical research study how different factors affected their decisions. Most respondents were either strongly or moderately influenced by the possibility that the research would help themselves (82%) or their family (78%). Other factors that had considerable influence were:
More detailed analysis of the factors that influence study participation will be presented in later reports.
factors that influenced decision to participate
Most of our respondents (93%) said they would participate in a research study again, with only a few (0.4%) stating they would not, and the rest saying they were unsure.
Even though most patients were willing to participate again, we did hear a number of comments regarding what participants would change about clinical research. For example, many patients expressed the desire to be informed of the results of the study, as summed up by the following respondents’ statements:
“I wish I had received information on what was found. Six years later, I never found out the results. The staff promised to get me info but I heard nothing further.”
“I wish that results of the research that are published were available to participants without having access to expensive subscriptions to costly medical journals.”
Others expressed the desire to know after the study had completed to which group they had been randomized. One respondent noted:
“I think it’s reasonable that the participants get to know if they have taken placebos or the real medication after the study is finished.”
Finally, participants expressed the need for more costs to be covered by the study. One person told us:
“I feel more of my medical costs should have been covered…plus the doctors involved should have been more open about what they were doing at my expense.”
We asked our respondents if they had ever declined participating in a specific research study. Overall, about 15% of respondents said they had declined specific studies. When we looked at people who had previously participated in research, we found a similar but slightly larger group (21%) had declined.
has respondent ever declined participation in a research study?
Respondents were asked to what degree different factors affected their decision to decline participation in a specific study. About 63% said that feeling the time was not right to participate in a study either moderately or strongly affected their decisions. Other factors that strongly or moderately influenced decisions include: being told they were not eligible for the study (58%), concern about the time the study would take (57%), desire to not get a placebo (53%), required travel (52%), not wanting to be randomized to one of the study groups (50%), belief that the study would not help them (46%), and concern that insurance would not cover costs associated with the study (41%).
reasons why respondents declined research studies
Many respondents further explained their reasoning in their comments. Many expressed concerns about side effects of the drug:
“Potential cardiac risk. Cardiac family history.”
“The treatment was too toxic and there were other options less toxic that were available.”
Others spoke of the burden of gathering all the information needed for the trial:
“Too much information was needed about background and I was too sick to get the documents done.”
“One of the requirements for participation was that I needed to know exactly what kind of ovarian cancer my cousin had. As my female cousin had already passed away from ovarian cancer, I did not feel comfortable contacting her brother/sister asking them for the specifics of their sister’s cancer.”
Our survey found that most people who have participated in clinical research were satisfied with their experience and would participate in future trials. Reasons for participating include the belief that the trial will help themselves or their family members.
In our next report, we will discuss what information patients need to better understand, whether or not they want to participate in a clinical trial. In the coming year, we will use these results to improve the clinical research information that we present to the FORCE community.