- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03178383
Integration of Cancer Health Activities Into African American Churches
31. oktober 2022 opdateret af: University of Maryland, College Park
The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels.
It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time.
This project will make important contributions to research in evidence-based medicine and sustainability.
In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This population-based application responds to the American Cancer Society Research Scholar Grant, Priority Program in Cancer Control.
Recent years have seen a growing research interest in learning how to get known-effective health education strategies to reach more people who could benefit from them.
An important part of this growing movement is a focus on sustained impact, or continued program benefit after the funding period is over.
It is believed that the best way to achieve this sustained impact is through integrating the program into the host community at multiple levels.
This innovative strategy has not been systematically tested in community-based settings, where the most vulnerable people can be reached.
Since churches have a historical and ever-growing role in health promotion particularly among African Americans, they are an ideal place to reach this group for cancer education.
The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels.
It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time.
The educational strategy is one that has been used successfully in previous work: Project Health through Early Awareness and Learning (HEAL).
Project HEAL is a series of three cancer early detection workshops (breast, prostate, colorectal) delivered through trained and certified lay peer community health advisors in African American churches.
14 churches will be randomly chosen to conduct either the standard Project HEAL program or an integrated Project HEAL strategy where the churches build the program into their organization in multiple ways (e.g., allocating volunteer or paid staff, space, or funds; policy change; ministry development).
The project will be conducted in three phases: 1) refining the integrated approach with community and stakeholder feedback; 2) pilot testing the integrated approach in 2 churches; and 3) conducting the study to comparatively evaluate the standard vs. the integrated approaches in 14 churches.
A scientifically rigorous evaluation plan will be used to look at outcomes at both the individual and the church level.
This project will make important contributions to research in evidence-based medicine and sustainability.
In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
446
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
College Park, Maryland, Forenede Stater, 20742
- University of Maryland School of Public Health
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Advisory Panel members: adults ages 21+
- Pastors, representing each of the 14 churches enrolled in the project: active pastor of churches enrolled in the study
- Community Health Advisors
- Self-identified African American
- Adults ages 21+
- Regularly attend church services
- Able to complete Project HEAL training
- Able to recruit 40+ participants for a breast, prostate, or colorectal cancer educational workshop
- Able to lead the breast, prostate, and colorectal cancer workshops
- Workshop Participants
- Self-identified African American
- Adults ages 21+
- Have no history of breast, prostate, or colorectal cancer
Exclusion Criteria:
- Workshop Participants: Men and women who have had breast, prostate, or colorectal cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Integrated Approach
In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g.
men's, women's, seniors).
|
In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g.
men's, women's, seniors).
|
Aktiv komparator: Standard Comparison
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
|
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Integration of health-relation practices assessed via church survey
Tidsramme: Change from baseline to 12 and 24 months
|
Intervention impact on institutionalization at 12 and 24 months
|
Change from baseline to 12 and 24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Tidsramme: Up to 4 months
|
Participants from priority population engaged in intervention
|
Up to 4 months
|
Efficacy: Increased knowledge of cancer as assessment by participant surveys
Tidsramme: Up to 12 months
|
Cancer-related knowledge
|
Up to 12 months
|
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Tidsramme: Up to 12 months
|
Self-reported cancer screening
|
Up to 12 months
|
Adoption
Tidsramme: At recruitment/enrollment
|
Cooperation rate of churches
|
At recruitment/enrollment
|
Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff
Tidsramme: Up to 4 months
|
Adherence to intervention protocol
|
Up to 4 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cheryl L Holt, PhD, Professor
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.
Generelle publikationer
- Knott CL, Chen C, Bowie JV, Mullins CD, Slade JL, Woodard N, Robinson-Shaneman BR, Okwara L, Huq MR, Williams R, He X. Cluster-randomized trial comparing organizationally tailored versus standard approach for integrating an evidence-based cancer control intervention into African American churches. Transl Behav Med. 2022 May 26;12(5):673-682. doi: 10.1093/tbm/ibab088.
- Knott CL, Bowie J, Mullins CD, Santos SLZ, Slade J, Rosenberg E, Woodard N, Williams R, Williams RM. An Approach to Adapting a Community-Based Cancer Control Intervention to Organizational Context. Health Promot Pract. 2020 Mar;21(2):168-171. doi: 10.1177/1524839919898209. Epub 2020 Jan 20.
Hjælpsomme links
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)
1. juli 2016
Primær færdiggørelse (Faktiske)
30. juni 2022
Studieafslutning (Faktiske)
30. juni 2022
Datoer for studieregistrering
Først indsendt
18. maj 2017
Først indsendt, der opfyldte QC-kriterier
5. juni 2017
Først opslået (Faktiske)
6. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. november 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2022
Sidst verificeret
1. oktober 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RSG-16-022-01-CPPB
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 .
Kliniske forsøg med Brystkræft
-
Cairo UniversityIkke rekrutterer endnu
-
Abouqir General HospitalAlexandria UniversityRekrutteringBreast Udseende Rekonstruktion DisproportionEgypten
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbejdspartnereAfsluttetDen kliniske anvendelsesvejledning af Conebeam Breast CTKina
-
ETOP IBCSG Partners FoundationAfsluttetBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAfsluttetBreast Cancer Invasive NosSpanien
-
Ontario Clinical Oncology Group (OCOG)Afsluttet
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...UkendtBRCA1 mutation | Breast Cancer Invasive NosPolen
-
Aga Khan UniversityAfsluttetBrystkræft | Perforatorklap | Brysttumor | Oncoplasty | Breast-QPakistan
-
University Health Network, TorontoAfsluttetBreast Cancer Invasive Nos | Primær invasiv brystkræftCanada
-
KU LeuvenNovartisUkendtER Positive, HER2 Negative Breast Cancer NeoplasmaBelgien
Kliniske forsøg med Project HEAL 2.0
-
Acandis GmbHRekrutteringIntrakraniel aneurismeTyskland
-
Cornell CollegeNational Institute of Mental Health (NIMH)AfsluttetSpiseforstyrrelseForenede Stater
-
Duke UniversityAfsluttetModstandsdygtighedForenede Stater
-
Michigan State UniversityUnited States Department of Agriculture (USDA); Blue Cross Blue Shield...Afsluttet
-
Chulalongkorn UniversityThai Red Cross AIDS Research Centre; International AIDS SocietyAfsluttetHIV-forebyggelse | Overholdelse, Medicin | Teenagers adfærd | Mobil sundhed | Seksuel sundhedThailand
-
University of California, San DiegoStanford University; California HIV/AIDS Research ProgramAfsluttet
-
Northwestern UniversityTrukket tilbage
-
Acandis GmbHRekrutteringIntrakraniel aneurisme | Flow omlederTyskland
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)Afsluttet
-
Fisher and Paykel HealthcareNorth Texas Lung & Sleep ClinicAfsluttetObstruktiv søvnapnøForenede Stater