- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03178383
Integration of Cancer Health Activities Into African American Churches
31. oktober 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
446
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
College Park, Maryland, Forente stater, 20742
- University of Maryland School of Public Health
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cheryl L Holt, PhD, Professor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2016
Primær fullføring (Faktiske)
30. juni 2022
Studiet fullført (Faktiske)
30. juni 2022
Datoer for studieregistrering
Først innsendt
18. mai 2017
Først innsendt som oppfylte QC-kriteriene
5. juni 2017
Først lagt ut (Faktiske)
6. juni 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. november 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. oktober 2022
Sist bekreftet
1. oktober 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RSG-16-022-01-CPPB
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Brystkreft
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbeidspartnereFullførtThe Clinical Application Guide of Conebeam Breast CTKina
-
Novartis PharmaceuticalsFullførtMetastatisk brystkreft (MBC) | Locally Advance Breast Cancer (LABC)Storbritannia, Spania
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkjentHR-positiv, HER2-negativ og PIK3CA Mutation Advanced Breast CancerKina
-
Cancer Institute and Hospital, Chinese Academy...Har ikke rekruttert ennå
-
Emory UniversityNational Cancer Institute (NCI)TilbaketrukketPrognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i hjernen | Metastatisk brystkarsinom | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)FullførtAnatomisk stadium IV brystkreft AJCC v8 | Prognostisk stadium IV brystkreft AJCC v8 | Metastatisk malign neoplasma i beinet | Metastatisk malign neoplasma i lymfeknutene | Metastatisk malign neoplasma i leveren | Metastatisk brystkarsinom | Metastatisk malign neoplasma i lungen | Metastatisk malign neoplasma... og andre forholdForente stater, Canada, Saudi-Arabia, Sør -Korea
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione... og andre samarbeidspartnereRekrutteringBrystkreft | Brystneoplasmer | Bryst sykdommer | Neoplasma i brystet | Brystsvulster | Brystkarsinom | Brystneoplasmer, mannlige | Brystkreft stadium IV | Hormonreseptorpositiv ondartet neoplasma i brystet | HR-positiv brystkreft | Hormonreseptorpositivt brystkarsinom | Hormonreseptor (HR)-positiv brystkreft | Hormonreseptorpositiv... og andre forholdItalia
-
University of California, DavisNational Cancer Institute (NCI)RekrutteringAnatomisk stadium III brystkreft AJCC v8 | Avansert malignt solid neoplasma | Stadium III lungekreft AJCC v8 | Stadium IV lungekreft AJCC v8 | Stadium III nyrecellekreft AJCC v8 | Stadium IV nyrecellekreft AJCC v8 | Klinisk stadium III kutant melanom AJCC v8 | Trinn IV tykktarmskreft AJCC v8 | Klinisk stadium... og andre forholdForente stater
Kliniske studier på Project HEAL 2.0
-
Duke UniversityFullførtMotstandsdyktighetForente stater
-
Cornell CollegeNational Institute of Mental Health (NIMH)Fullført
-
Chulalongkorn UniversityThai Red Cross AIDS Research Centre; International AIDS SocietyFullførtHIV-forebygging | Overholdelse, medisinering | Ungdomsadferd | Mobil helse | Seksuell helseThailand
-
Duke UniversityFullførtStoffbruk | Mental HelseForente stater
-
Centers for Disease Control and PreventionHealth Research AssociationAvsluttetKlamydiaForente stater
-
Michigan State UniversityUnited States Department of Agriculture (USDA); Blue Cross Blue Shield...Fullført
-
BrainQ Technologies Ltd.Fullført
-
Healables Ltd.Wolfson Medical CenterPåmelding etter invitasjon
-
Boston University Charles River CampusHar ikke rekruttert ennå
-
Midwest Evaluation & ResearchAnthem Strong FamiliesFullført