This application poses a novel recruitment method designed to overcome some of the sociocultural barriers experienced by women as they consider the clinical trials process by applying the results and theories of outreach and health behavior research. The goal of the study is to investigate the feasibility of overcoming sociocultural barriers to clinical trials participation for breast cancer patients through the systematic use of survivors serving as role models.
The specific aims of the research are 1) to develop (a recruitment and training program to instruct breast cancer survivors from various cultural backgrounds, who were also clinical trial participants, to serve as role models) and assist in the information and accrual process; 2) to develop a systematic approach for the role models to contact women eligible for clinical trial participation in order to discuss the process, experiences, and potential benefits of participation; and 3) to evaluate the feasibility of using these methods at the institutional and cooperative group level. It is hypothesized that training culturally appropriate cancer survivors as role models to contact prospective breast cancer clinical trial participants will improve the accrual process for patients, increase the number of patients participating, alleviate physician constraints, and provide a systematic mechanism for applying this process and model to other clinical research settings. Based on prior outreach research, this study will recruit a minimum of six breast cancer survivors, one each from lower, middle and upper income African American and Caucasian backgrounds to serve as role models. These survivors will be trained to talk with other women about their experiences as clinical trial participants, and the benefits and problems of that experience. The study will investigate two methods of contacting patients - direct/person-to-person and telephone. Qualitative and quantitative evaluation of the two-year study will be based on encounter surveys, focus group discussions, participation outcome measures, and process evaluation, such as attrition, staff evaluations, and qualitative ethnographic notes. The proposed study is the initial, single institution phase of a planned two-phase study which will investigate the survivor model prospectively in a cooperative group setting.
