Trial Title:
Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial
NCT ID:
NCT06314672
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Accrual
Description:
Participate in AEP
Arm group label:
Phase I (interview, discussion, review, AEP, education)
Arm group label:
Phase II (AEP, education, interviews)
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Participate in implementation discussions
Arm group label:
Phase I (interview, discussion, review, AEP, education)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Educational Activity
Description:
Participate in educational sessions/activities
Arm group label:
Phase I (interview, discussion, review, AEP, education)
Arm group label:
Phase II (AEP, education, interviews)
Intervention type:
Other
Intervention name:
Interview
Description:
Undergo interview
Arm group label:
Phase I (interview, discussion, review, AEP, education)
Arm group label:
Phase II (AEP, education, interviews)
Arm group label:
Phase III (interview)
Intervention type:
Other
Intervention name:
Review
Description:
Undergo data capture review
Arm group label:
Phase I (interview, discussion, review, AEP, education)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Phase I (interview, discussion, review, AEP, education)
Arm group label:
Phase II (AEP, education, interviews)
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.
Detailed 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)
Criteria for eligibility:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Electra D. Paskett, PhD
Phone:
614-293-3917
Email:
electra.paskett@osumc.edu
Investigator:
Last name:
Electra D. Paskett, PhD
Email:
Principal Investigator
Start date:
August 22, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06314672
http://cancer.osu.edu
