Abstract OT3-03-01: Increasing participation in research - Breast cancer
Authors: BN Robinson, SM Swain
Journal: Cancer Research (2016)

Abstract PURPOSE: Increasing Black patients' participation in cancer clinical trials is particularly important because of the population's lower survival rate. Accrual to clinical trials remains low among the general population (1-3%), with recruitment of Blacks the lowest of all groups at 0.5-1.5%. INSPIRE-BrC aims to increase trial participation rates among Black breast cancer patients and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. METHODS: The study was approved by the Institutional Review Board at all sites and opened in March 16, 2014. Black breast cancer patients at five MedStar sites will view a 15 minute, culturally-tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. A pre-test/post-test method is used to determine the impact of the video on three variables -- likely participation in therapeutic clinical trials; attitudes toward therapeutic clinical trials (assessed based on the 6 barriers); and actual trial enrollment. Participants are followed for six months after participating in the intervention to assess clinical trial enrollment status. ELIGIBILITY CRITERIA: The study includes patients with invasive breast cancer, who are Black or African American and have never participated in a therapeutic clinical trial. Participants can be male or female and must be 18 years or older. EXPECTED FINDINGS: We hypothesize that the intervention will increase clinical trial enrollment compared to our 2012 clinical trial enrollment baseline rate of 6% (22/384) for Black breast cancer patients in five MedStar hospitals. The primary outcome measure is the proportion of Black breast cancer patients who agree to participate in a therapeutic clinical trial among those who sign consent to INSPIRE-BrC. Study findings have the potential to increase patient recruitment as a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among Black cancer patients. STATISTICAL METHODS: Bivariate associations between enrollment status and patient-level characteristics will be examined by t-tests for continuous variables and chi-square tests for categorical variables. Paired t-tests and McNemar's test for paired proportions will be used to measure the changes in attitudes and beliefs, measured based on pre-post test. Multiple logistic regression models will be used to predict enrollment status including many factors identified in the literature as predictors, which are, but not limited to age, gender, SES, insurance status, and stage. ACCRUAL: As of June 2, 2015, the total accrual across all five sites is 177 patients. INSPIRE enrollments as of June 2, 2015MedStar Franklin Square Medical Center10MedStar Georgetown University Hospital16MedStar Harbor Hospital12MedStar Union Memorial Hospital19MedStar Washington Hospital Center120Total177 The accrual goal is 200 patients. We anticipate meeting this goal in July 2015, and analyzing the data in January 2016. CONTACT: Brandi N. Robinson, MPH Program Manager Oncology Research MedStar Health Research Institute Washington Cancer Institute at MedStar Washington Hospital Center 110 Irving Street, NW, Room C-2149, Washington, DC 20010 Phone: (202) 877-3058 |Fax: (202) 877-4072 Brandi.n.robinson@medstar.net Citation Format: Robinson BN, Swain SM. Increasing participation in research - Breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-03-01.