- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03178383
Integration of Cancer Health Activities Into African American Churches
31 octobre 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
446
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Maryland
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College Park, Maryland, États-Unis, 20742
- University of Maryland School of Public Health
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Integration of health-relation practices assessed via church survey
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Délai: 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
Délai: Up to 12 months
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Cancer-related knowledge
|
Up to 12 months
|
|
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Délai: Up to 12 months
|
Self-reported cancer screening
|
Up to 12 months
|
|
Adoption
Délai: 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
Délai: Up to 4 months
|
Adherence to intervention protocol
|
Up to 4 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Cheryl L Holt, PhD, PROFESSOR
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2016
Achèvement primaire (Réel)
30 juin 2022
Achèvement de l'étude (Réel)
30 juin 2022
Dates d'inscription aux études
Première soumission
18 mai 2017
Première soumission répondant aux critères de contrôle qualité
5 juin 2017
Première publication (Réel)
6 juin 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 novembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 octobre 2022
Dernière vérification
1 octobre 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RSG-16-022-01-CPPB
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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