Author: Sue Friedman, DVM, is Executive Director for Facing Our Risk of Cancer Empowered (FORCE) which is a lead organization in PCORnet’s ABOUT Patient Powered Research Network (PPRN). Friedman is a Co-Principal Investigator for ABOUT.
It’s an exciting time for hereditary cancer research as the pace of new personalized medicine treatments and targeted therapies has increased. But for these new therapies to translate into better health, they must be tested on specific populations through clinical trials. Unfortunately, less than 5% of adults with cancer enroll in clinical trials and about a fifth of adult cancer clinical trials fail to recruit enough participants to complete the research.
Matching patients to clinical trials for prevention, detection and treatment is even more challenging for groups that are a subset of a larger disease population, such as people with, or at high risk for hereditary breast, ovarian, pancreatic, melanoma and prostate cancers (HBOC) such as those enrolled in the ABOUT Network.
ABOUT is a PPRN within PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). ABOUT grew out of the work of a national nonprofit advocacy organization for individuals and families impacted by HBOC — Facing Our Risk of Cancer Empowered, Inc. (FORCE) — and a multiyear collaboration between FORCE and hereditary cancer researchers at the University of South Florida Morsani College of Medicine.
In 2015, FORCE, received a Celgene Innovative Impact Award to develop more HBOC patient-friendly resources to help our community learn about, and enroll in specific clinical trials. The project used the resources of ABOUT to engage in a pilot program that sought to improve clinical trial participation for hereditary breast and ovarian cancer by identifying patients’ information needs around clinical trials and developing patient-friendly education and clinical trial matching materials. The project had three key components: a survey, a custom research matching database and educational tools.
Community voice on research participation
The community engagement survey we designed for this project included over 1,100 cancer survivors and “previvors” (high-risk individuals who are survivors of a predisposition to cancer but who haven’t had the disease.) Not surprisingly, the results indicated that the technical language of clinical trials and the challenge for patients to determine whether they are eligible present substantial barriers. Many participants also expressed frustration that they did not get to learn the results of the research study in which they participated. Dissemination of research results is an active area of focus for FORCE and ABOUT and when we collaborate with researchers, we help them share their results back to the community.
Research study search tool
The project’s second component is our new and improved research study search tool. It searches two databases for studies enrolling people with HBOC: clinicaltrials.gov and FORCE’s own custom study database which is enriched with studies enrolling people with or at high risk for hereditary cancer. Users can look up studies by type:
- Prevention and detection
- Risk assessment
- Quality of life and wellbeing
- Registries, surveys and interviews
Searches may also be sorted by the type of cancer, specific genetic mutations, tumor markers and keywords.
The tool provides an easy-to-read, user-friendly description of the study, which defines inclusion and exclusion criteria, an overview of what is expected of participants, information about enrolling sites and the study contact information. The dynamic glossary feature provides definitions of research terms without leaving the webpage. All of these easy-to-read and user friendly features help address the challenges that survey respondents expressed regarding technical language and complicated eligibility criteria. Making the tool easily searchable by different categories helps reduce the difficulty of matching patients to clinical trials.
The third component, which also focuses on eliminating the barriers mentioned in the survey, is the development of new educational resources about:
- Why you should consider enrolling in research
- How to find research studies for which you are eligible
- Legal protections for participants
- Frequently asked questions about clinical trials.
We are now developing training modules so that our 200 volunteers can assist patients in using the tool and direct them to additional resources.
We are already integrating the research study search tool we developed through this project into ABOUT efforts, for example our most recent ABOUT participant newsletter included a “featured research” link to the study portal we created. ABOUT is also using what we learned through this project to inform people about the Athena WISDOM Study, a PCORI- funded study that aims to determine whether we can improve breast cancer screening by incorporating risk assessment into the process.
Athena WISDOM Study
The Athena WISDOM Study is a PCORI-funded study that aims to determine whether we can improve breast cancer screening by incorporating risk assessment into the process.
- Read PCORI’s Blog Post on the Athena WISDOM Study.
A patient advocate who was trained by FORCE has been actively engaged in the WISDOM study team, from writing its grant, planning recruitment efforts and participating in the future dissemination of study results. We are also excited about using our matching tool to enroll participants in the PCORI funded “Healthy Mind, Healthy You: A Study of Mindfulness” Cross-PPRN study.
We are well on our way to achieving our goal to better target study promotion to the most appropriate audiences and track use and outcomes. Ultimately, we hope that this work will further the mission of PCORI and PCORnet and bring patients and researchers together. Stay tuned for updates over the next year!
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.