Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314672
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-10-31
Brief Title:
Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University CUSP2CT Project Trial
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
The Ohio State University Connecting Underrepresented Populations to Clinical Trials CUSP2CT Project
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 racialethnic 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 racialethnic minorities to preventioncontrol 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 hematologicand others and examine factors at the system ie 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 OSUCCCJames 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 OSUCCCJames 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
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 hematologicand others and examine factors at the system ie 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 OSUCCCJames 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 OSUCCCJames 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-02217 | REGISTRY | None | None |
| U01CA274999 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU01CA274999 |