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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-22-PCRP-IDA | Other Grant/Funding Number | Department of Defense | |
| NCI-2024-06410 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CoLLab | Other Identifier | Mayo Clinic | |
| 23-007988 | Other Identifier | Mayo Clinic in Florida |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Service | Other | Access CoLLab Learning Health System to use any of the services |
|
| 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 |
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Inclusion Criteria:
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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Quincy Wimberly | Contact | 904-953-0974 | Wimberly.Quincy@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Folakemi T. Odedina, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Questionnaire Administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003153 | Community Health Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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