Patient education intervention to improve diversity in breast cancer clinical trials.
Authors: Simmons Kristen , Podany Emily L , Hernandez-Herrera Anadulce , Hoyos Valentina , Henry Giselle , Sanchez Daisy , Coronel Cristina , Hildebrandt Rebecca , Bulsara Shaun , Hilsenbeck Susan G. , Niravath Polly Ann , Badr Hoda , Ellis Matthew James , Nemati Shafaee Maryam 
Published: September 2022

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Background: Patient education has been shown to improve clinical trial participation. Medically underserved, racial, and ethnic minorities have a lower participation rate in cancer clinical trials (CCT) than patients of high socioeconomic status (SES). Our comprehensive cancer center is notable for providing equal access to breast CCT (BCCT) through a private system (McNair) and a public safety net hospital system, Smith Clinic (SC). Our prior research has shown that SC cancer patients, who are 60% uninsured, predominantly low SES, and >80% racial minorities, are 40% less likely to enroll into BCCT compared to McNair patients who are > 95% insured and largely White. Methods: We developed a 7-minute video with testimonies of our current patients (who are of diverse racial and linguistic backgrounds) about their BCCT experience and testimonies of our research team discussing misconceptions surrounding BCCT and biospecimen collection. The video was designed to be culturally sensitive and used simplified terms in English, Spanish, and Vietnamese. We modified a validated questionnaire by UT Health San Antonio, Institute for Health Promotion Research to assess participants’ attitudes towards CCT participation before and after watching the video. We used a Wilcoxon Signed Rank test to measure the effect of the video on a 5-point Likert scale with 5 indicating “Extremely likely”, 3 “Moderately Likely” and 1 “Not Likely at all”. The primary outcome was a shift in likelihood of participation in a CCT by 1. Other outcomes included assessing the effects of English proficiency, residing in United States (US) for at least 10 years, race, stage of breast cancer diagnosis (high risk vs. early stage vs. metastatic disease) using Chi-squared tests. With 200 survey respondents, the study had 97% power to detect the desired primary outcome. The project was supported by a Pfizer education grant. Results: A total of 200 patients (73 at McNair and 127 at SC) watched the video and completed the surveys. 93 identified as Hispanic, 50 as African American, 14 as Asian, 47 as White, and 7 as other races. The mean pre-intervention score for likelihood of willingness to participate in a CCT was 3.34 (SD 1.45) at McNair and 2.81 (SD 1.28) at SC. The mean post-intervention score was 3.89 (SD 1.28) at McNair and 3.44 (SD 1.22) at SC. While the pre- and post-intervention scores were significantly different across the two sites (p = 0.01 and p = 0.015 respectively), the study did not meet its primary objective. English proficiency, residing in US for at least 10 years, race, and stage of breast cancer diagnosis were not significantly associated with the outcome. Conclusions: Our patient education video did not improve our patients’ willingness to participate in BCCT as much as we had hoped. This suggests that a comprehensive approach is required to improve our community’s engagement and close the disparity gap in BCCT enrollment.