Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men

Not Applicable

Recruiting

• Conditions: Prostate Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06541210
• Lead Sponsor: Mayo Clinic

Brief Summary

This clinical trial the possibility of establishing a Community Living Labs (CoLLab) Learning Health System to facilitate access to prostate health Risk, Education, and Assessment in the Community with Help (REACH) services in Black men and compares the impact to American Legion Posts with no CoLLab set up at the individual and community levels. Cancer is the second leading cause of death for Black men and Black men are less likely to receive prostate cancer screening. CoLLab Learning Health System utilizes community health workers (CHW) that are well-trained to form a bridge between communities and clinicians. In fact, Black men who work with CHW's typically have better access to health services, gain knowledge about cancer, cancer prevention, treatment and may have better overall health outcomes. Establishing a CoLLab Learning Health System at American Legion Posts may improve access to clinical trials and prostate cancer services in Black men.

Detailed Description

PRIMARY OBJECTIVES:

I. Co-create real-life user centric CoLLab Learning Health System at three American Legion Posts, compared to an American Legion Post with no CoLLab set-up. American Legion Post 197 will serve as the hub and Post 244 and Post 194 as the spokes.

II. Assess and evaluate the impact of the CoLLab Learning Health Systems compared to the comparison Post at the individual and community levels.

III. Explore the feasibility of replicating the CoLLab Learning Health System in Black communities nationally.

OUTLINE:

Participants access CoLLab Learning Health System to use any of the services at least twice monthly for up to 1 year.

Study Timeline

• Study Start: 2024-05-04
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• AIMS 1 AND 3: Participants must be one of the following key personnel:

  • Community PI (n=1),
  • CoLLab Program Manager (n=1)
  • CoLLab Site Managers (n=3)
  • CoLLab CAB members (n=21)
  • 2 Community Health Workers (CHWs) per Post site (n=6)

• AIMS 1 AND 3: Between the ages of 21 and 80.

• AIMS 1 AND 3: Able to complete the survey in English.

• AIMS 1 AND 3: Reside in the Jacksonville, FL and/or surrounding counties.

• AIMS 1 AND 3: Willing and able to consent to the study.

• AIM 2: Black adult of any gender.

• AIM 2: Must be between the ages of 30 and 80.

• AIM 2: Able to speak English.

• AIM 2: Reside in the Jacksonville, FL and/or surrounding counties.

• AIM 2: Willing and able to consent to the study.

Exclusion Criteria

• AIMS 1 AND 3: Younger than 21years or older than 80 years.
• AIMS 1 AND 3: Not a resident of NE Florida. Unwilling or unable to consent to the study.
• AIM 2: Younger than 30 years or older than 80 years.
• AIM 2: Not a resident of NE Florida.
• AIM 2: Unwilling or unable to consent to the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Participants complete surveys and may participate in an interview on study.

Primary Outcome Measures

Name	Time	Method
Create real-life user centric CoLLab Learning Health System (program production)	Up to 12 months	Qualitative data collection will be employed during a town hall meeting with the CoLLab Community Advisory Board (CAB) to ensure that we get unbiased and objective feedback from participants.
Impact of the CoLLab Learning Health Systems	Baseline; up to 12 months	Will be assessed using pre-test and post-test survey scores from a Prostate Health Resources Questionnaire, which consists of 6 multiple choice questions, 8 true/false/don't know questions, 13 questions answered on a 5-point scale (e.g., very favorable to unfavorable or strongly agree to strongly disagree), and 20 yes/no questions.
Feasibility of Replication - cost analysis	Up to 24 months	Will be assessed using cost analysis of direct and indirect costs.
Feasibility of Replication - qualitative	Up to 24 months	Will be assessed qualitatively based on interviews of key personnel and users

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States