Overcoming Barriers to Early Phase Clinical Trials

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DESCRIPTION (provided by applicant) Patient accrual is a longstanding obstacle to clinical research. Despite widespread importance placed on clinical trials of all phases, research estimates that less than 5% of new cancer patients are enrolled on clinical trials of all phases and types. The barriers to clinical trials enrollment are multi-faceted, with physician, patient, and system components. Similar barriers seem to affect the entire country and, specifically, all NCI-designated Cancer Centers. This is particularly the case in early phase clinical trials, where therapeutic effectiveness is less definitive than in later phase studies. This application proposes to explore four major barriers to early phase clinical trials - lack of insurance coverage, communication issues, physician time constraints, and trust/understanding issues - utilizing simple and reproducible models that, if effective, could be easily translated in other Cancer Centers, or in other disease areas. The specific aims of this proposal are: 1) To determine if there is a significant difference in treatment cost for patients treated on early phase clinical trials versus an alternative commercially available chemotherapeutic agent(s) or best supportive care, and to assess the effectiveness of using the resulting data in overcoming insurance coverage barriers to accrual, 2) To evaluate the extent to which new communication models/technologies can bolster early phase clinical trials accrual, 3) To assess the ability of a new staffing model to overcome the barrier of physician and staff time constraints and to increase accrual to early phase clinical trials, and 4) To test whether a coaching intervention engenders trust and communication in minority patients thereby enhancing accrual to early phase clinical trials.