Enhancing Minority Participation in Clinical Trials (EMPaCT):Phase II

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The objective of EMPaCT Phase II is to increase recruitment and retention of racial/ethnic minorities into therapeutic clinical trials through the well-established EMPaCT consortium and in partnership with the American Cancer Society, with the ultimate goal of reducing cancer-related health disparities. Two Strategies will be employed to achieve this objective: a) education and training approach, implemented through Web-based modules; and b) intervention approach, which will establish a patient navigation and clinical trial support system. These strategies will be pursued through the following specific aims: 1. Establish a Web-portal that: a) includes Web-based training modules customized for investigators, research staff, referring physicians, and patient navigators; b) provides resources for recruitment and retention; and c) serves as communications and information hub, in order to address identified barriers to recruitment and retention of minorities into therapeutic cancer clinical trials. 2. Implement and evaluate a patient navigation program designed to increase recruitment and retention of minority patients into therapeutic cancer clinical trials. 3. Development and pilot implementation of a) of clinical trials ombudsman at each of the five regional sites 1 to a) implement and evaluate the use of a standardized real-time tracking system of minority accrual into therapeutic clinical trials and b) to provide oversight and evaluation of patient navigation program c) develop and pilot evidence based recruitment and retention models in project years 3-5. The proposed specific aims are based on the findings of qualitative and quantitative assessments of barriers and facilitators of minority recruitment and retention into cancer clinical trials. These assessments were implemented by the EMPaCT consortium over 2 years across all five sites and were guided by a conceptual framework that highlights the multiple levels upon which barriers and facilitators occur.