Abstract A18: Increasing Participation in Research - Breast Cancer

Abstract

Abstract Increasing Participation in Research – Breast Cancer (INSPIRE-BrC) aims to increase therapeutic clinical trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. The study was opened in mid-March of 2014. 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 to 3%), with recruitment of blacks the lowest of all groups at 0.5 to 1.5%. Clinical trials are key to developing new methods to prevent, detect, and treat cancer. Methods: INSPIRE-BrC is a prospective nonrandomized clinical trial. A sample size of 123 black patients with breast cancer at five MedStar sites (two in the District of Columbia and three in the Baltimore area) will view a 15 minute, culturally tailored video about clinical trials, which targets six cultural and attitudinal barriers to participation. The six cultural and attitudinal barriers to participation that have been documented in literature and verified by the MedStar Washington Hospital Center, Washington Cancer Institute experience are: 1) Fear and distrust of the medical establishment (doctors, scientists and the government); 2) Concern about the ethical conduct of investigators (e.g., Tuskegee Syphilis Study); 3) Fear of losing one's rights by signing a research informed consent document ; 4) Worry that investigators will treat poor or minority patients unfairly (e.g., the patient becomes a guinea pig); 5) Loss of privacy; and 6) Lack of knowledge and awareness of clinical trials (e.g., what would be done, what would be expected from them and what are the expected risks and benefits of the research presented at participant's comprehension level). 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 six barriers); and actual trial enrollment. We will use the Attitudes and Intention to Enroll in therapeutic clinical Trials (AIET) questionnaire in which items were all adapted from existing scales that measured concepts similar to those assessed in this study. Each of six attitudinal barriers measured represent a subscale on the AIET consisting of five items, each assessed on a 5-point Likert-type scale. Responses are scored 1=Strongly Disagree; 2=Somewhat Disagree; 3=Not sure/Neither; 4=Somewhat Agree; 5=Strongly Agree. 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 patients with breast cancer in five MedStar hospitals. The primary outcome measure is the proportion of black patients with breast cancer 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 patients with cancer. INSPIRE- BrC Enrollment as of July 28, 2014 MedStar Franklin Square Medical Center - 5 MedStar Georgetown University Hospital - 6 MedStar Harbor Hospital -7 MedStar Union Memorial Hospital - 7 MedStar Washington Hospital Center - 40 Total - 65 Citation Format: Brandi N. Robinson, Sandra M. Swain. Increasing Participation in Research - Breast Cancer. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A18.