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

ConditionsHematopoietic and Lymphoid System NeoplasmMalignant Solid Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Accrual

    Procedure/Surgery

    Participate in AEP

  • Discussion

    Procedure/Surgery

    Participate in implementation discussions

  • Educational Activity

    Other intervention

    Participate in educational sessions/activities

  • Interview

    Other intervention

    Undergo interview

  • Review

    Other intervention

    Undergo data capture review

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

208 Participants
are divided into 3 treatment groups
Group A: Phase I (interview, discussion, review, AEP, education)Experimental treatment 6 interventions
Group B: Phase II (AEP, education, interviews)Experimental treatment 4 interventions
Group C: Phase III (interview)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Calculate change in clinical trial referrals

Time frame
Baseline to 24 months
2

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

Calculate the change in clinical trial minority enrollments

Time frame
Baseline to 24 months
3

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

Calculate accrual and retention rates

Time frame
Baseline to 24 months
4

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

Define gaps in trial accrual

Time frame
Up to 24 months

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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