OSUCCC CUSP2CT

Ohio State University, Columbus OH

Investigators

Abstract

PROJECT SUMMARY The overall goal of The Ohio State University (OSU) Accrual to Clinical Trials (ACTs) project is to increase the referral and accrual of participants to NCI’s National Clinical Trials Network (NCTN) prevention/control and treatment trials at the OSU Comprehensive Cancer Center (OSUCCC). This research is grounded in the socioecologic model developed by the Centers for Population Health and Health Disparities (Warnecke, et al. Am J Public Health 2008) and utilizes the theoretical model, Accrual to Clinical Trials (Paskett, et al. Clin Adv Hematol Oncol 2003). The OSUCCC serves the catchment area of the state of Ohio where over 95% of our patients with cancer reside. Working closely with the OSUCCC Center Community and Engagement (CCOE), OSUCCC National Outreach Network, community partner organizations, community providers in the OSUCCC referral area, James Hospital Network sites, NCI Community Oncology Research Program (NCORP) sites in Ohio, and the OSUCCC Clinical Trials Office, our goal will be accomplished by completing the following specific aims: 1) Conduct a baseline assessment of referral patterns and accrual of participants to clinical trials at OSUCCC by cancer disease group (breast, gastrointestinal, genitourinary, thoracic, hematologic, and others) and examine factors at the system (i.e., eligible clinical trial protocol, clinic context and culture), provider (trial discussed with patient), and patient level (agreed or refused participation) that influence referral and accrual (Phase I); 2) Implement a multi-level intervention in a stepped wedge design in referring practices in 9 counties with high counts of cancer cases in the OSUCCC catchment area using the Accrual to Clinical Trials framework (Paskett, et al. Clin Adv Hematol Oncol 2003), in Phase II. The intervention will include an outreach component, directed at community members and community practices, and an in-reach component, involving patients, providers, and the hospital system (at both referral centers and the OSUCCC) that directly addresses problems identified in Phase I; and 3) to evaluate the impact of the intervention on referral (primary outcome) and accrual patterns (secondary outcomes) in Phase III to clinical trials. Both qualitative and quantitative methods will be used. Dissemination of the key findings of our multi-level intervention is a high priority of this project.