- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06541210
Opbygning af Community Living Labs i sorte samfund for at fremme prostatasundhedslighed og reducere prostatacancerforskelle hos sorte mænd (CoLLab)
Opbygning af Community Living Labs (CoLLab) i sorte samfund med det mål at fremme prostatasundhedslighed og reducere prostatacancerforskelle hos sorte mænd
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
Undersøgelse Kontakt Backup
- Navn: Quincy Wimberly
- Telefonnummer: 904-953-0974
- E-mail: Wimberly.Quincy@mayo.edu
Studiesteder
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Florida
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Jacksonville, Florida, Forenede Stater, 32224-9980
- Rekruttering
- Mayo Clinic in Florida
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Kontakt:
- Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
-
Ledende efterforsker:
- Folakemi T. Odedina, Ph.D.
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Kontakt:
- Quincy Wimberly
- Telefonnummer: 904-953-0974
- E-mail: Wimberly.Quincy@mayo.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
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AIMS 1 AND 3: Between the ages of 21 and 80.
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AIMS 1 AND 3: Able to complete the survey in English.
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AIMS 1 AND 3: Reside in the Jacksonville, FL and/or surrounding counties.
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AIMS 1 AND 3: Willing and able to consent to the study.
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AIM 2: Black adult of any gender.
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AIM 2: Must be between the ages of 30 and 80.
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AIM 2: Able to speak English.
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AIM 2: Reside in the Jacksonville, FL and/or surrounding counties.
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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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Ancillary studies Access CoLLab Learning Health System to use any of the services
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Create real-life user centric CoLLab Learning Health System (program production)
Tidsramme: 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. |
Up to 12 months
|
|
Impact of the CoLLab Learning Health Systems
Tidsramme: 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. |
Baseline; up to 12 months
|
|
Feasibility of Replication - cost analysis
Tidsramme: Up to 24 months
|
Will be assessed using cost analysis of direct and indirect costs. |
Up to 24 months
|
|
Feasibility of Replication - qualitative
Tidsramme: Up to 24 months
|
Will be assessed qualitatively based on interviews of key personnel and users |
Up to 24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Folakemi T. Odedina, Ph.D., Mayo Clinic
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Prostatiske neoplasmer
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Fællesskabets sundhedsydelser
Andre undersøgelses-id-numre
- 23-007988
- 23-007988 (Anden identifikator: Mayo Clinic in Florida)
- NCI-2024-06410 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CoLLab (Anden identifikator: Mayo Clinic)
- W81XWH-22-PCRP-IDA (Andet bevillings-/finansieringsnummer: Department of Defense)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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