Clinical trial NCT06541210: Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men
Official title: Building Community Living Labs (CoLLab) in Black Communities With the Goal of Advancing Prostate Health Equity and Reducing Prostate Cancer Disparities in Black Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Create real-life user centric CoLLab Learning Health System (program production)
timeFrame: Up to 12 months
measure: Impact of the CoLLab Learning Health Systems
timeFrame: Baseline; up to 12 months
measure: Feasibility of Replication - cost analysis
timeFrame: Up to 24 months
measure: Feasibility of Replication - qualitative
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Folakemi T. Odedina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: