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

Building Community Living Labs (CoLLab) in Black Communities With the Goal of Advancing Prostate Health Equity and Reducing Prostate Cancer Disparities in Black Men

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Community Health Service

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Quincy Wimberly; Phone Number: 904-953-0974; Email: Wimberly.Quincy@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Folakemi T. Odedina, Ph.D.
      • Contact: Quincy Wimberly; Phone Number: 904-953-0974; Email: Wimberly.Quincy@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Adults who identify as Black and key personnel

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Community Health Service; Access CoLLab Learning Health System to use any of the services; Other Names: non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create real-life user centric CoLLab Learning Health System (program production)	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.	Up to 12 months
Impact of the CoLLab Learning Health Systems	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.	Baseline; up to 12 months
Feasibility of Replication - cost analysis	Will be assessed using cost analysis of direct and indirect costs.	Up to 24 months
Feasibility of Replication - qualitative	Will be assessed qualitatively based on interviews of key personnel and users	Up to 24 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Folakemi T. Odedina, Ph.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services; Health Care Facilities Workforce and Services; Community Health Services
• Other Study ID Numbers: 23-007988 (Other Identifier: Mayo Clinic in Florida); NCI-2024-06410 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CoLLab (Other Identifier: Mayo Clinic); W81XWH-22-PCRP-IDA (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No