PURPOSE: To assess @entity5 clinical trial recruitment and reasons for nonaccrual among a rural, medically underserved population served by a community-based @entity5 care center. METHODS: We prospectively tracked clinical trial enrollment incidence among all new @entity1 presenting at the Rapid City Regional Cancer Care Institute. Evaluating physicians completed questionnaires for each @entity1 regarding clinical trial enrollment status and primary reasons for nonenrollment. @entity1 who identified as American Indian were referred to a program where @entity1 were assisted in navigating the medical system by trained, culturally competent staff. RESULTS: Between September 2006 and January 2008, 891 new @entity5 @entity1 were evaluated. Seventy-eight @entity1 (9%; 95% confidence intervals, 7-11%) were enrolled on a clinical treatment trial. For 73% (95% confidence intervals, 69-75%) of @entity1 (646 of 891) lack of relevant protocol availability or protocol inclusion criteria restrictiveness was the reason for nonenrollment. Only 45 (5%; 95% confidence intervals, 4-7%) @entity1 refused enrollment on a trial. Of the 78 enrolled on a trial, 6 (8%; 95% confidence intervals, 3-16%) were American Indian. Three additional American Indian @entity1 were enrolled under a nontreatment @entity5 control trial, bringing the total percentage enrolled of the 94 American Indians who presented to the clinic to 10% (95% confidence intervals, 5-17%). LIMITATIONS: Eligibility rates were unable to be calculated and cross validation of the number in the cohort via registries or ICD-9 codes was not performed. CONCLUSION: Clinical trial participation in this medically underserved population was low overall, but approximately 3-fold higher than reported national accrual rates. Lack of availability of protocols for common @entity5 sites as well as stringent protocol inclusion criteria were the primary obstacles to clinical trial enrollment. Targeted interventions using a @entity1 Navigation program were used to engage AI @entity1 and may have resulted in higher clinical trial enrollment among this racial/ethnic group.

Involving American Indians and medically underserved rural populations in XXXX clinical trials.

@entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'Patient']
@entity5 :: (MESH:D009369,Disease) :: ['cancer']
