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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-02217 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U01CA274999 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Phase III (interview) | Experimental | Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accrual | Procedure | Participate in AEP |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Electra D Paskett, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Discussion | Procedure | Participate in implementation discussions |
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| Educational Activity | Other | Participate in educational sessions/activities |
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| Interview | Other | Undergo interview |
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| Review | Other | Undergo data capture review |
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| Survey Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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