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

NCT ID: NCT06541210

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-04
• Study Completion Date: 2027-09-30

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.

Conditions

Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Health services research (CoLLab Learning Health System)

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

Group Type: EXPERIMENTAL

Community Health Service

Intervention Type: OTHER

Access CoLLab Learning Health System to use any of the services

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Community Health Service

Access CoLLab Learning Health System to use any of the services

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

non-interventional study

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Folakemi T. Odedina, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Quincy Wimberly

Role: CONTACT

Wimberly.Quincy@mayo.edu

904-953-0974

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Quincy Wimberly

Role: backup

Wimberly.Quincy@mayo.edu

904-953-0974

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

W81XWH-22-PCRP-IDA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NCI-2024-06410

Identifier Type: REGISTRY

Identifier Source: secondary_id

CoLLab

Identifier Type: OTHER

Identifier Source: secondary_id

23-007988

Identifier Type: OTHER

Identifier Source: secondary_id

23-007988

Identifier Type: -

Identifier Source: org_study_id