Patient education intervention to improve breast cancer clinical trials participation.
Authors: Nemati Shafaee Maryam , 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 
Published: June 2022

e18532

Background: Patient education has been shown to improve clinical trial participation. Medically underserved, racial, and ethnic minorities have 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 through a private system (Baylor McNair) and a public safety net hospital (Harris Health Smith Clinic). Our prior research has shown that breast cancer patients at Smith Clinic (SC) who are 60% uninsured, predominantly of low SES, and 80% racial and ethnic minorities are 40% less likely to enroll compared to McNair patients where patients are > 95% insured and largely Caucasian. Methods: We developed a 7-minute video consisting of current patients’ testimonies of their CCT experience along with the research team discussing misconceptions regarding CCT 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 for measuring 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 stated likelihood of participation in a CCT by 1 point. Using Chi-squared test, we assessed whether English proficiency or residing in the United States (US) for more than 10 years affected the results. Patients’ reason for refusing CCT was documented. With 200 survey responders, 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. 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. There were also no significant differences in the willingness to participate in CCT with regards to time spent in the US or English proficiency. Most frequent reasons for refusal were concern about extra costs, extra time commitment and the need to discuss the trial with family members. Conclusions: Our in-house developed patient education video did not improve patients’ willingness to participate in CCT 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 the treatment and outcomes of breast cancer.