Bridging Disciplinary Boundaries (January 11 - 14, 2007)

Rationale: Ethnic minority patients with cancer are significantly underrepresented in randomized clinical trials. This paper reports on socio-culturally grounded strategies to enhance the recruitment of low-income, predominantly Latina women with cancer that have resulted in relatively high rates of participation in two NIH funded clinical trials of social work interventions. Methods: Improving Patient Access and Adherence to Cancer Treatment (IMPAACT) and Alleviating Depression Among Patients with Cancer (ADAPt-C) are two randomized clinical trials testing the effectiveness of a structured case management and patient navigation intervention model and a socio-culturally tailored collaborative approach to depression care implemented in an urban public sector oncology care system. Based on known barriers to participation, we implemented participant and investigator focused strategies. Facilitating strategies included: communication and human subjects consent process adapted for low-literacy, and monolingual speaking; study recruiters were bilingual and bicultural; recruitment was conducted at a time during their regular clinic visit that was patient convenient; clinic nursing and medical staff support for study recruitment was successfully obtained; baseline data collection accommodated patient preferences –e.g., in the clinic or via telephone, daytime, evenings or weekends; incentives included the opportunity to receive modest service enhancements for usual care patients and considerable additional services for intervention patients; telephone outcome interviews at patient convenience; and recruiter follow-up to maintain current telephone number or address. Results: Targeted IMPAACT enrollment of 500 patients was completed within 25 months; enrollment of targeted 350 ADAPt-C patients within 22 months. The 850 enrolled cancer patients were predominantly Latina (81.5%), Spanish-speaking (73%), and foreign-born (86.7%). Participation rates were ADAPt-C 79.9%; IMPAACT 80.5%. Only 13% of the 974 patients who met study inclusion criteria refused to participate. Of the 124 “refusers”, 88 were Latina, 14 Asian, 10 White, 6 African American, and 5 “Other.” Common self-reported reasons for non-participation were: patient living in another state most of the time and inability to frequently travel or frequent travel to native country; family gate-keeping; reluctance and discomfort with signing consent forms; wanting immediate monetary incentive; daily stressors/ practical responsibilities; not wanting to be in usual care arm of study, physical limitations (i.e. “feeling sick” , “pain”, “too tired”); desire to keep feelings private; feeling depressed or anxious; pessimism about participating; or just “not interested.” Implications: The high rate of study participation in these trials suggests that socio-culturally grounded recruitment strategies are effective in facilitating recruitment low-income, ethnic minority patients in a public sector oncology care system. Reducing population disparities in randomized clinical trials is a critical factor in the development of evidence-based knowledge for practice, particularly with respect to learning about culturally competent practice.