There is a striking racial and ethnic disparity in incidence and mortality of cancer yet minorities remain markedly underrepresented in clinical trials. This pilot study set out to determine the impact of a 15-min culturally tailored educational video on three outcomes relating to clinical trials: likely participation, attitudes (assessed based on six barriers), and actual enrollment. Breast cancer patients with Stage I-III, if diagnosed within previous 6 months, or metastatic disease who self-identified as black or African American were invited to participate. The primary outcome measure was the decision to participate in a therapeutic clinical trial after the intervention. Patients’ intention to enroll on a therapeutic clinical trial and the change in attitudes toward clinical trials were measured by the previously developed Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) questionnaire. Of the 200 patients that participated, 39 (19.5%) patients signed consent to participate in a therapeutic clinical trial; 27 (13.5%) patients enrolled, resulting in a 7.5% increase from our baseline comparison of 6% clinical trial enrollment rate in black cancer patients (p < .001). Pre-test versus post-test assessment demonstrated the proportion of patients expressing likelihood to enroll in a therapeutic trial following the intervention increased by 14% (p < .001). Among 31 AIET items, 25 (81%) showed statistically significant and positive change post-intervention. The findings suggest the promising utility of a culturally tailored video intervention for improving black patients’ attitudes regarding clinical trial participation and resultant enrollment. Future efforts should continue to target facilitators of population-specific recruitment, enrollment, and retention in therapeutic and non-therapeutic clinical trials.

BackgroundClinical trials test new ways to prevent, detect, diagnose, or treat diseases. Researchers have found that minority patients are willing to participate in clinical trials, yet these patients have barriers which hinder their access to trials.MethodsTo explore African American women's participation in breast cancer clinical trials, eight focus groups were conducted with breast cancer patients, family members/care givers, religious leaders, and healthcare providers to gather information on the perspectives and opinions on the topic. The focus group conversations were transcribed, and transcripts were imported into QSR International's NVivo 10 software. The transcripts were organized into folders based on four categories. The content analysis performed was based on recordings and notes.ResultsThe following themes were generated as a result of conducting these focus groups and gathering information on the perspectives and opinions about participating in clinical trials, based on the groups who participated: Promoting participation in research; Personal experience with cancer; Support and support services; Awareness, knowledge, and experience with clinical trials; Providers' roles in clinical trials.ConclusionThe data collected in this study present several actionable themes that, if addressed by individual researchers and the medical community at large, could increase participation in clinical trials by African American patients. They also provide a deeper and more nuanced understanding of the factors influencing African American patients' decisions around participating in clinical trials.

53 Background: 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. INSPIRE-BrC aims to increase trial participation rates among black patients with breast cancer and examine the relationship between the intervention and attitudes/beliefs on the decision to participate. Methods: A sample size of 123 black patients with breast cancer 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. 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. [Table: see text]

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.