Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial

The Ohio State University

Status: Enrolling

Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Review; Other: Interview; Procedure: Accrual; Procedure: Discussion; Other: Educational Activity; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06314672

NCI-2023-02217 (Registry Identifier)

OSU-22318

U01CA274999 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 208 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Phase I: 9 counties in the OSUCCC catchment area
• Phase II: Patients, providers, and hospital systems/referral centers that directly addresses challenges identified in Phase I
• Phase II: The project will involve the OSUCCC, the OSU James Cancer Network sites and the Columbus and Dayton NCORP sites

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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208 participants in 3 patient groups

Phase I (interview, discussion, review, AEP, education)

Experimental group

Description:

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)

Treatment:

Other: Survey Administration

Other: Educational Activity

Procedure: Discussion

Procedure: Accrual

Other: Interview

Other: Review

Phase II (AEP, education, interviews)

Experimental group

Description:

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)

Treatment:

Other: Survey Administration

Other: Educational Activity

Procedure: Accrual

Other: Interview

Phase III (interview)

Experimental group

Description:

Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)

Treatment:

Other: Interview