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

NCT06541210 | Recruiting

• 4 other identifiers: 23-007988W81XWH-22-PCRP-IDANCI-2024-06410CoLLab
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Health services research (CoLLab Learning Health System)

EXPERIMENTAL

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

Questionnaire Administration OTHER

Ancillary studies

Health services research (CoLLab Learning Health System)

Community Health Service OTHER

Access CoLLab Learning Health System to use any of the services

Also known as: non-interventional study

Health services research (CoLLab Learning Health System)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Community Health Services

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Folakemi T. Odedina, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Quincy Wimberly

CONTACT

904-953-0974; Wimberly.Quincy@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: May 4, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)