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

NCT06314672 | Recruiting DMC

• 3 other identifiers: OSU-22318NCI-2023-02217U01CA274999
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (5)

• Change in referral rate to clinical trials (CTs) (short-term outcomes)

  Calculate change in clinical trial referrals

  Baseline to 24 months

• Change in accrual of minorities to CTs (short-term outcomes)

  Calculate the change in clinical trial minority enrollments

  Baseline to 24 months

• CT accrual and retention due to patient navigation (short-term outcomes)

  Calculate accrual and retention rates

  Baseline to 24 months

• Identification of program gaps in trial accrual (long-term outcomes)

  Define gaps in trial accrual

  Up to 24 months

• Uptake of program in other clinics (long-germ outcomes)

  Calculate the number of clinics who adapt program

  Up to 24 months

Secondary Outcomes (1)

• Probability of trial enrollment and retention

  Up to 24 months

Study Arms (3)

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

EXPERIMENTAL

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

Phase II (AEP, education, interviews)

EXPERIMENTAL

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

Phase III (interview)

EXPERIMENTAL

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

Other: Interview

Interventions

Accrual PROCEDURE

Participate in AEP

Phase I (interview, discussion, review, AEP, education); Phase II (AEP, education, interviews)

Discussion PROCEDURE

Participate in implementation discussions

Also known as: Discuss

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

Educational Activity OTHER

Participate in educational sessions/activities

Phase I (interview, discussion, review, AEP, education); Phase II (AEP, education, interviews)

Interview OTHER

Undergo interview

Phase I (interview, discussion, review, AEP, education); Phase II (AEP, education, interviews); Phase III (interview)

Review OTHER

Undergo data capture review

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

Survey Administration OTHER

Ancillary studies

Phase I (interview, discussion, review, AEP, education); Phase II (AEP, education, interviews)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Electra D Paskett, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: March 18, 2024
• Study Start: August 22, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)