Recruiting

CUSP2CT

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06314672

Conditions

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Accrual

Discussion

Educational Activity

Interview

Review

Study Details

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

Study ID

NCT06314672

Start date

Aug 22, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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)

experimental: Phase II (AEP, education, interviews)

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)

experimental: Phase III (interview)

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

Interventions

Accrual

Participate in AEP

Discussion

Participate in implementation discussions

Educational Activity

Participate in educational sessions/activities

Interview

Undergo interview

Review

Undergo data capture review

Survey Administration

Ancillary studies

Primary outcome measure

  • Change in referral rate to clinical trials (CTs) (short-term outcomes) [ Time Frame: Baseline to 24 months ]
  • Change in accrual of minorities to CTs (short-term outcomes) [ Time Frame: Baseline to 24 months ]
  • CT accrual and retention due to patient navigation (short-term outcomes) [ Time Frame: Baseline to 24 months ]
  • Identification of program gaps in trial accrual (long-term outcomes) [ Time Frame: Up to 24 months ]
  • Uptake of program in other clinics (long-germ outcomes) [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Electra D. Paskett, PhD

614-293-3917electra.paskett@osumc.edu

Principal Investigator:

Electra D. Paskett, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-06-09.