CClinicalTrials.gg
RecruitingNCT06541210CoLLabUpdated Sep 29, 2026

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

An interventional study of Community Health Service and Questionnaire Administration in Prostate Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Carcinoma

Browse trials for

03

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • 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: Community Health Service · Other: Questionnaire Administration

Interventions

  • OtherCommunity Health Service

    Access CoLLab Learning Health System to use any of the services

    Also known as: non-interventional study

  • OtherQuestionnaire Administration

    Ancillary studies

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 months

  2. 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.

    Time frame: Baseline; up to 12 months

  3. Feasibility of Replication - cost analysis

    Will be assessed using cost analysis of direct and indirect costs.

    Time frame: Up to 24 months

  4. Feasibility of Replication - qualitative

    Will be assessed qualitatively based on interviews of key personnel and users

    Time frame: Up to 24 months

06

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    Recruiting
07

References and documents

Publications

  • Odedina FT, Bolajoko O, Wimberly Q, Lee D, Willis F, Moutlrie T, Ford W, Green D, Merriweather A, Turner J, Fudge M. Feasibility of Establishing Community Living Labs (CoLLabs) to Improve Access to Prostate Health Resources, Education, Amenities, and Community Health: Protocol for a Pragmatic Clinical Trial. JMIR Res Protoc. 2026 May 15;15:e89330. doi: 10.2196/89330. PubMed 42139705 ↗
08

Registry details

Key details

Study ID
NCT06541210
Lead sponsor
Mayo Clinic
Collaborators
Congressionally Directed Medical Research Programs
Responsible party
Sponsor
First posted
Aug 7, 2024
Start date
May 4, 2024
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Quincy Wimberly
Contact
Wimberly.Quincy@mayo.edu
904-953-0974
Folakemi T. Odedina, Ph.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion