- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03178383
Integration of Cancer Health Activities Into African American Churches
31 de octubre de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
446
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Maryland
-
College Park, Maryland, Estados Unidos, 20742
- University of Maryland School of Public Health
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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).
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Integration of health-relation practices assessed via church survey
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Periodo de tiempo: 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
Periodo de tiempo: Up to 12 months
|
Cancer-related knowledge
|
Up to 12 months
|
|
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Periodo de tiempo: Up to 12 months
|
Self-reported cancer screening
|
Up to 12 months
|
|
Adoption
Periodo de tiempo: 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
Periodo de tiempo: Up to 4 months
|
Adherence to intervention protocol
|
Up to 4 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cheryl L Holt, PhD, Professor
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de julio de 2016
Finalización primaria (Actual)
30 de junio de 2022
Finalización del estudio (Actual)
30 de junio de 2022
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2017
Primero enviado que cumplió con los criterios de control de calidad
5 de junio de 2017
Publicado por primera vez (Actual)
6 de junio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de noviembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
31 de octubre de 2022
Última verificación
1 de octubre de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RSG-16-022-01-CPPB
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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