Abstract A034: Extending the reach of genetic counseling to the safety net: Study design and recruitment challenges of a randomized trial
Authors: Guerra Claudia , Lee Robin , Stewart Susan L , Kaplan Celia , Joseph Galen , Tsoh Janice , Dixit Niharika , Cedermaz Heather , Kim Jin , Campbell Jane , Wang Lily X , Khoury Amal , Hellman-Wylie Cindy , Pasick Rena J 
Published: September 2020

Abstract
Genetic counseling (GC) for hereditary breast and ovarian cancer is available mainly in academic settings. Despite equal risk, most low income public hospital patients remain unaware and untested. Remote counseling may be a solution, but research has been limited to phone counseling for insured patients. Our study compares in-person, phone, and video conference GC among high-risk patients in 3 public hospitals to determine the comparative effectiveness of GC delivered across modes with regard to patients’ knowledge, cancer distress, decisional conflict, perceived stress, risk perception, satisfaction, and recall. We also assessed whether patients have a preference for counseling mode and how that affects outcomes. This report describes the study design and lessons learned regarding recruitment. We conducted a multicenter partially randomized preference noninferiority trial with English-, Spanish-, and Cantonese-speaking patients assigned by randomization or patients´ preference to one of the three GC modes. High-risk patients were identified using a family history screener in clinics or by physician referral. Study staff verified risk by phone, invited participation, conducted informed consent, and administered a baseline survey. Enrollees were asked whether they could be randomized or if they preferred one GC mode. They were then given a GC appointment and called again within 2 weeks of counseling for a follow-up survey. Power calculations required 270 randomized patients. A total of 23,401 screener forms yielded 824 likely to be high-risk; 656 completed baseline surveys. Race/ethnic composition was 40% Latinx, 25% white, 19% African American, and 8% Asian. Of these, 531 were counseled, and 505 completed final surveys (283 from randomized patients). The majority (64%) of non-randomized patients chose counseling by phone, 33% chose in person, 3% chose video. • At every step, participation exceeded our projections, showing that diverse low-income patients were interested in participating in research that they deemed relevant. • Our greatest recruitment challenges were due more to settings than to patients. Collection of screeners varied greatly by month and/or clinic. Oncologists valued the risk services offered by the study, but intensive engagement was necessary with front-line staff/supervisors because of their job demands. • Partial randomization functioned well. Prior studies showed that many high-risk women refuse randomization for GC. Adding a preference arm necessitated a larger sample, but greater inclusiveness yields more generalizable findings. • Recruitment of Chinese-speaking patients was low (2.5%) due largely to structural barriers which we continue to explore. Practice-based safety net research presents numerous challenges that require close partnerships, extensive planning, and highly skilled staff capable of sensitive personnel engagement. The work is rewarded by real-world findings, the sine qua non in efforts to eliminate cancer disparities.
Citation Format: Claudia Guerra, Robin Lee, Susan L Stewart, Celia Kaplan, Galen Joseph, Janice Tsoh, Niharika Dixit, Heather Cedermaz, Jin Kim, Jane Campbell, Lily X Wang, Amal Khoury, Cindy Hellman-Wylie, Rena J Pasick. Extending the reach of genetic counseling to the safety net: Study design and recruitment challenges of a randomized trial [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A034.