Abstract P5-14-02: Breast cancer clinical trial participation rate among patients of low socioeconomic status at a comprehensive cancer center
Authors: Shafaee Maryam Nemati , Podany Emily L , Sanchez Katherine , Higashiyama Nicole , Hoyos Valentina , Micheal Liz Binu , Otte Kristen , Pavlick Anne , Nangia Julie , Kuriakose Alphi , Osborne Kent C , Jibaja-Weiss Maria , Ellis Matthew J , Bulsara Shaun , Rimawi Mothaffar 
Published: March 2022

Abstract
Background: Patients with higher socioeconomic status (SES) are overrepresented in NCI-sponsored cancer clinical trials (CCT). Inadequate access, social and cultural barriers have been described as reasons for poor accrual of patients with low SES into clinical trials. Racial minorities including African Americans (AA) and Hispanics are underrepresented in CCT and often experience issues related to lack of access. On the other hand, survey studies throughout United States suggest equal willingness for participation in CCT among all racial categories. When access to CCT is not a barrier to enrollment, the rate of CCT participation by Racial and Ethnic minorities with low SES is not well studied. Methods: We performed a retrospective review of the database of new patients screened for breast CCT at Dan L Duncan Comprehensive Cancer Center (DLDCCC). DLDCCC is an ideal venue for studies on clinical trial diversity because it provides cancer care to two very different patient demographics: 1) Smith Clinic is a Harris Health System (HHS) cancer clinic where a majority of the patients are of low SES; half of our patients earn less than $25,000 annually, 60% are uninsured using a county financial assistance program called “Gold Card”, 65% are unable to speak proficient English, and 52% are Hispanic, 25% AA, 9% Caucasian and 5% Asian, 2) Baylor St Luke’s Medical Center (BSLMC) serves predominantly Caucasian patients with &gt;95% of the patients having federal or commercial insurance. Cancer clinical trials are available at both sites, and all patients across the two clinics have equal opportunity for enrollment. The database dates back to 5/2015 and includes 3,084 patients. Using the chi-squared test, we compared the rate of trial availability, trial eligibility and enrollment for breast CCT between two patient populations receiving care at Smith clinic vs. BSLMC. We tabulated the rate of trial participation decline at each clinic per year from 5/2015 to 6/2021. The study had IRB approval from Baylor College of Medicine.Results: Among the 3,084 new-to-practice patients, 1,664 patients were seen at BSLMC and 1,420 were seen at Smith Clinic. Clinical trials were available for 758 (53.4%) patients at Smith clinic and 742 (44.6%) patients at BSLMC, p&lt;0.001. Patients were eligible for clinical trials at a similar rate at each site: 193 (25.5%) at Smith Clinic and 182 (24.5%) at BSLMC clinic. Patients at Smith Clinic were more likely to decline clinical trial enrollment compared to BSLMC (62.2% vs. 41.8%, P&lt;0.001). The rate of CCT participation decline was consistent across the years, 2015-2021. Conclusion: While access to clinical trials has been considered a major rate limiting step towards improving diversity in clinical trials, our experience at DLDCCC Breast Clinics suggests that patients with low SES more frequently refuse trial enrollment even when they have access and are trial eligible. Factors underlying our population’s excess reluctance for enrollment onto CCT at Smith clinic compared to BSLMC is currently under investigation, to be reported at the SABCS.
Citation Format: Maryam Nemati Shafaee, Emily L Podany, Katherine Sanchez, Nicole Higashiyama, Valentina Hoyos, Liz Binu Micheal, Kristen Otte, Anne Pavlick, Julie Nangia, Alphi Kuriakose, Kent C Osborne, Maria Jibaja-Weiss, Matthew J Ellis, Shaun Bulsara, Mothaffar Rimawi. Breast cancer clinical trial participation rate among patients of low socioeconomic status at a comprehensive cancer center [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-14-02.