An interventional study of Accrual and Discussion in Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Health services research
This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials.
PRIMARY OBJECTIVES:
I. Conduct a baseline assessment of referral patterns and accrual of racial and ethnic minorities to clinical trials at Ohio State University Comprehensive Cancer Center (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 levels (agreed or refused participation) that influence referral and accrual. (Phase I) II. Implement a multi-level intervention in a stepped wedge design in referral in 10 counties in the OSUCCC catchment area using the Accrual to Clinical Trials framework. (Phase II) III. Evaluate the impact of the intervention on referral (primary outcome) and accrual (secondary outcomes) to clinical trials. (Phase III)
OUTLINE: Counties are cluster randomized to 1 of 3 steps in Phase II of the study.
PHASE I (DEVELOPMENT): Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. Accrual enhancement program (AEP) strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)
PHASE II (IMPLEMENTATION): Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)
PHASE III (EVALUATION): Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)
Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. AEP strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)
Procedure: Accrual · Procedure: Discussion · Other: Educational Activity · Other: Interview · Other: Review · Other: Survey Administration
Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)
Procedure: Accrual · Other: Educational Activity · Other: Interview · Other: Survey Administration
Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)
Other: Interview
Participate in AEP
Participate in implementation discussions
Also known as: Discuss
Participate in educational sessions/activities
Undergo interview
Undergo data capture review
Ancillary studies
Change in referral rate to clinical trials (CTs) (short-term outcomes)
Calculate change in clinical trial referrals
Time frame: Baseline to 24 months
Change in accrual of minorities to CTs (short-term outcomes)
Calculate the change in clinical trial minority enrollments
Time frame: Baseline to 24 months
CT accrual and retention due to patient navigation (short-term outcomes)
Calculate accrual and retention rates
Time frame: Baseline to 24 months
Identification of program gaps in trial accrual (long-term outcomes)
Define gaps in trial accrual
Time frame: Up to 24 months
Uptake of program in other clinics (long-germ outcomes)
Calculate the number of clinics who adapt program
Time frame: Up to 24 months
Probability of trial enrollment and retention
Recent regression models used for stepped wedge designs that flexibly model the effect curve of the intervention over time. Effect estimates and 95% confidence intervals will accompany significance tests, and graphical displays of the final effect curve will aid in understanding the efficacy of the intervention.
Time frame: Up to 24 months
Plan to share: No
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Ohio State University Comprehensive Cancer Center