Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
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)
Interventions
PROCEDUREAccrual
Participate in AEP
PROCEDUREDiscussion
Participate in implementation discussions
OTHEREducational Activity
Participate in educational sessions/activities
OTHERInterview
Undergo interview
OTHERReview
Undergo data capture review
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in referral rate to clinical trials (CTs) (short-term outcomes) | Baseline to 24 months | Calculate change in clinical trial referrals |
| Change in accrual of minorities to CTs (short-term outcomes) | Baseline to 24 months | Calculate the change in clinical trial minority enrollments |
| CT accrual and retention due to patient navigation (short-term outcomes) | Baseline to 24 months | Calculate accrual and retention rates |
| Identification of program gaps in trial accrual (long-term outcomes) | Up to 24 months | Define gaps in trial accrual |
| Uptake of program in other clinics (long-germ outcomes) | Up to 24 months | Calculate the number of clinics who adapt program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probability of trial enrollment and retention | Up to 24 months | 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. |
Countries
United States
Contacts
Primary ContactThe Ohio State Comprehensive Cancer Center
Outcome results
None listed