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Opbygning af Community Living Labs i sorte samfund for at fremme prostatasundhedslighed og reducere prostatacancerforskelle hos sorte mænd (CoLLab)

25. september 2026 opdateret af: Mayo Clinic

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

Rekruttering

Betingelser

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

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224-9980
        • Rekruttering
        • Mayo Clinic in Florida
        • Kontakt:
        • Ledende efterforsker:
          • Folakemi T. Odedina, Ph.D.
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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)
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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:
  • ikke-interventionsundersøgelse

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Folakemi T. Odedina, Ph.D., Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. maj 2024

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

2. august 2024

Først indsendt, der opfyldte QC-kriterier

2. august 2024

Først opslået (Faktiske)

7. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

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

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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