Abstract P3-10-02: Increasing participation in research - breast cancer (Inspire-BrC)
Authors: Swain S , Robinson BN , Newman AF , Tefera E , Herbolsheimer P , Nunes R , Gallagher C , Randolph-Jackson P , Omogbehin A , Dilawari A , Pohlmann P , Mohebtash M , Ottaviano Y , Mohapatra A , Lynce F , Mete M 
Published: March 2017

Background: Increasing Black patients' participation in cancer clinical trials is important because of the population's lower survival rate. Accrual for Blacks is the lowest of all groups at 0.5-1.5%. Our study aims to increase trial participation rates among Black breast cancer patients by testing the effectiveness of a culturally tailored video intervention on the decision to participate in a clinical trial.

Methods: We hypothesized that the intervention would increase clinical trial enrollment by 6 percentage points compared to our 2012 enrollment baseline of 6% (22/384). Self- identified Black patients with invasive breast cancer at 5 MedStar Hospitals watched a 15' video about clinical trials, targeting six cultural and attitudinal barriers to participation. The Attitudes and Intention to Enroll in therapeutic clinical Trials (AIET) pre-/post-/follow-up tests with 31 items was used to determine the impact of the video on three domains: actual trial enrollment; likely participation in trials; and attitudes toward trials. The pre-test was conducted at baseline; post-test immediately after video; and follow-up 7-21 days after the intervention. Participants were followed for 6 months to assess trial enrollment status. Descriptive statistics were used to describe study subjects with respect to basic characteristics; means and standard deviations for continuous variables; and frequencies and percentages for categorical variables. Repeated measures analysis of variance was used to examine whether the changes in attitudinal barriers were statistically significant over time. The primary outcome measure was the proportion of Black breast cancer patients who signed consent and/or enrolled in a therapeutic clinical trial.

Results: From Mar/2014 to Sept/2015, 279 patients were approached to join INSPIRE-BrC prior to discussion about therapeutic clinical trials; 52 declined participation. 208 signed consent and 200 completed it. Average age was 59 yrs (SD=12), 75% were stage I-III; 29% were married; 85% had 1 or more children; 29% attended some college or technical school; 53% had private insurance, 31% Medicare, 16% Medicaid; and 53% had a household income &lt;$40,000/yr. A total of 41 INSPIRE-BrC participants (20.5%) signed consent and 29 (14.5%) enrolled onto a therapeutic study (one-sided p=0.027 vs H0: P=0.06). Pre-video, 52% of patients expressed that it was likely they would participate in a hypothetical therapeutic clinical trial; immediately post-video, 67% (p=&lt;0.001) and 7-21 days after the intervention, 64% (p=0.003). Among 31 AIET items, 25 (81%) showed statistically significant and positive change after the intervention. Specifically, trust in the doctor increased and, suspicion in trials decreased (p&lt;0.001). Further, patient views on fairness for treatment of poor people and Blacks became significantly more positive (p&lt;0.001).

Conclusion: Study findings show that the video is a promising tool for rapid dissemination of a theory-driven, evidence-based model to enhance clinical trial accrual among Black cancer patients. The video also has the potential to positively change attitudes about clinical trial participation.

The study was supported by the Breast Cancer Research Foundation.

Citation Format: Swain S, Robinson BN, Newman AF, Tefera E, Herbolsheimer P, Nunes R, Gallagher C, Randolph-Jackson P, Omogbehin A, Dilawari A, Pohlmann P, Mohebtash M, Ottaviano Y, Mohapatra A, Lynce F, Mete M. Increasing participation in research - breast cancer (Inspire-BrC) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-10-02.