Prostate CarcinomaCoLLabNCT06541210
Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men
A study testing Community Health Service and Questionnaire Administration in people with Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Community Health Service and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Quincy Wimberly, 904-953-0974, Wimberly.Quincy@mayo.edu
About this study
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
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:
- 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
- Being tested
- Community Health Service, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health ServiceOther
Also called non-interventional study
Access CoLLab Learning Health System to use any of the services
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Community Health Service; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline; up to 12 months
Feasibility of Replication - cost analysis
Will be assessed using cost analysis of direct and indirect costs.
Measured: Up to 24 months
Feasibility of Replication - qualitative
Will be assessed qualitatively based on interviews of key personnel and users
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start4 May 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Folakemi T. Odedina, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541210
- Sponsor's protocol ID
- 23-007988
- Other IDs
- W81XWH-22-PCRP-IDA, NCI-2024-06410, CoLLab, 23-007988
- Acronym
- CoLLab
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06541210
- Acronym / sponsor ID
- CoLLab / 23-007988
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 4 May 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (CoLLab Learning Health System) | Experimental | Other: Community Health Service, Other: Questionnaire AdministrationParticipants access CoLLab Learning Health System to use any of the services at least twice monthly for up to 1 year. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- AIMS 1 AND 3: Participants must be one of the following key personnel:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health ServiceAlso: non-interventional studyAccess CoLLab Learning Health System to use any of the services | Other | Health services research (CoLLab Learning Health System) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (CoLLab Learning Health System) |
Primary outcome
Create real-life user centric CoLLab Learning Health System (program production)
Time frame: Up to 12 months
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.
Impact of the CoLLab Learning Health Systems
Time frame: Baseline; up to 12 months
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.
Feasibility of Replication - cost analysis
Time frame: Up to 24 months
Will be assessed using cost analysis of direct and indirect costs.
Feasibility of Replication - qualitative
Time frame: Up to 24 months
Will be assessed qualitatively based on interviews of key personnel and users
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 42139705Odedina 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Folakemi T. Odedina, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Service and Questionnaire Administration in people with Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create real-life user centric CoLLab Learning Health System (program production) (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06541210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.