WASHINGTON—In an effort to improve the quality of life for Latina women with breast cancer, the Patient-Centered Outcomes Research Institute (PCORI) has awarded a three-year contract to a researcher at Georgetown University here. The organization notes that quality-of-life issues for Latina breast cancer survivors remain a little-studied area in the United States despite the growth in the nation's Latina population.
The new study that the grant will fund, believed to be the first of its kind, builds on lessons learned by community-based organizations in helping Latino families cope with post-traumatic stress disorder following 9/11.
PCORI, an independent, nonprofit organization authorized by Congress in 2010 and established by the Government Accountability Office (GAO), funds clinical comparative effectiveness research, with the goal of enhancing evidence-based health care decision-making. As part of that mission, PCORI funds studies that address disparities in U.S. health care. The project on Latina breast cancer survivors has been awarded $1,975,625 over the three-year project period.
“One in three Latina women will face cancer in their lifetimes, and there is documented evidence that Latinas with cancer have a lower quality of life,” said principal investigator Kristi Graves, PhD, Assistant Professor of Oncology and a member of the Cancer Control Program at Georgetown University Lombardi Comprehensive Cancer Center.
Speaking at a meeting of PCORI's Board of Governors in Washington that was open to dial-in listeners, Graves described the project, which involves working with Latina breast cancer survivors by partnering with four community-based organizations in Washington, New York, and California, which will include researchers, clinicians, patients, caregivers, and advocates.
The project will use a psychological support intervention developed by Latina survivors and employed successfully at Nueva Vida, a community-based support organization.
Graves noted that many Latina survivors lack health insurance or access to uninterrupted cancer care, including follow-up care, and that there is a need to improve adherence to follow-up care among Latina breast cancer survivors.
“Clinicians don't always feel confident in providing referrals to support services. We hope to provide empirical support for a program to enhance provider confidence in referrals to support programs.”
In addition to language and literacy barriers, the survivors may have feelings of isolation and beliefs that cancer is a death sentence, Graves said. Compounding Latina survivors' problems, she said, is the fact that their caregivers (family members or friends) often feel they lack the coping skills to help support the survivor.
Design of the Study
Graves described her study design for the PCORI Board of Governors. “No other research has tested this program,” she noted. The design includes 200 people (100 survivor/caregiver pairs).
Survivors diagnosed at any stage of disease or at any length of time since diagnosis may participate. The pairs will be assigned by chance to the intervention or to usual care (usual care includes case management or support groups); the psychological intervention consists of attending eight group sessions, held twice a month.
Each session will be led by a trained facilitator and will cover a different topic: communication, stress management, and treatment side effects or the impact of treatment on the family. Topics will be based on the needs of survivors and their caregivers, with suggestions and contributions from oncologists.
The study will employ quality-of-life test measures, Graves said. “There was an initial concern for us for the patients in usual care; we built that into our numbers. We felt we needed to randomize to make it robust.”
Interestingly, survivors and caregivers will meet at the same time, but in different rooms, said Graves. This separation is important, she said, because it allows survivors to share their feelings about what they are experiencing without fear of burdening the caregiver, and vice versa.
This way, survivors can develop skills individually that make a beneficial difference in their relationship. “After each session, everyone comes together to discuss the topic,” Graves said. Study participants will complete surveys before the intervention, immediately after, and six months later.
Graves said she believes the study “will be a very robust test of the intervention.”
PCORI Board of Governors Chair Grayson Norquist, MD, MSPH, Chair of the Department of Psychiatry and Human Behavior at the University of Mississippi Medical Center, asked how the intervention might be implemented on a broad basis if the results are successful in improving quality of life.
Graves responded that the intervention could be quickly employed through outreach efforts to more than 150 “local and national groups that provide care and support to tens of thousands of Latino families facing cancer.” Gilda's Clubs, for example, she said, have told her that they will help to disseminate the quality-of-life intervention to their affiliates if the study results are positive. And, she noted, “I've been working with Nueva Vida for years on smaller projects. That mattered.”
PCORI Executive Director Joe V. Selby, MD, MPH, said the organization has to date approved 197 funding awards totaling $273.5 million to researchers in 36 states and the District of Columbia, and by the end of this year that figure will be $400 million, and the expectation is that it will rise to $500 million in 2014.