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NCT06314672 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

Official title:
The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) Project

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06314672
Other study ID # OSU-22318
Secondary ID NCI-2023-02217U0
Status Recruiting
Phase N/A
First received
Last updated
Start date August 22, 2023
Est. completion date December 31, 2025

Study information
Verified date March 2024
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 208
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Accrual
Participate in AEP
• Discussion
Participate in implementation discussions
Other:
• Educational Activity
Participate in educational sessions/activities
• Interview
Undergo interview
• Review
Undergo data capture review
• Survey Administration
Ancillary studies

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in referral to clinical trials (CTs) (short-term outcomes) Calculate change in clinical trial referrals Baseline to 24 months
Primary Change in accrual of minorities to CTs (short-term outcomes) Calculate the change in clinical trial minority enrollments Baseline to 24 months
Primary CT accrual and retention due to patient navigation (short-term outcomes) Calculate accrual and retention rates Baseline to 24 months
Primary Identification of program gaps in trial accrual (long-term outcomes) Define gaps in trial accrual Up to 24 months
Primary Uptake of program in other clinics (long-germ outcomes) Calculate the number of clinics who adapt program Up to 24 months
Secondary 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. Up to 24 months
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