The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Change in referral rate to clinical trials (CTs) (short-term outcomes)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Phase II (AEP, education, interviews)
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)
干预措施: Survey Administration (Other)
Phase I (interview, discussion, review, AEP, education)
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)
干预措施: Accrual (Procedure)
Phase I (interview, discussion, review, AEP, education)
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)
干预措施: Discussion (Procedure)
Phase I (interview, discussion, review, AEP, education)
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)
干预措施: Educational Activity (Other)
Phase I (interview, discussion, review, AEP, education)
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)
干预措施: Interview (Other)
Phase I (interview, discussion, review, AEP, education)
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)
干预措施: Review (Other)
Phase I (interview, discussion, review, AEP, education)
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)
干预措施: Survey Administration (Other)
Phase II (AEP, education, interviews)
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)
干预措施: Accrual (Procedure)
Phase II (AEP, education, interviews)
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)
干预措施: Educational Activity (Other)
Phase II (AEP, education, interviews)
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)
干预措施: Interview (Other)
Phase III (interview)
Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)
干预措施: Interview (Other)
结局指标
主要结局
Change in referral rate to clinical trials (CTs) (short-term outcomes)
时间窗: Baseline to 24 months
Calculate change in clinical trial referrals
Change in accrual of minorities to CTs (short-term outcomes)
时间窗: Baseline to 24 months
Calculate the change in clinical trial minority enrollments
CT accrual and retention due to patient navigation (short-term outcomes)
时间窗: Baseline to 24 months
Calculate accrual and retention rates
Identification of program gaps in trial accrual (long-term outcomes)
时间窗: Up to 24 months
Define gaps in trial accrual
Uptake of program in other clinics (long-germ outcomes)
时间窗: Up to 24 months
Calculate the number of clinics who adapt program
次要结局
- Probability of trial enrollment and retention(Up to 24 months)
研究者
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center