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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03178383
Other study ID # RSG-16-022-01-CPPB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date June 30, 2022

Study information

Verified date October 2022
Source University of Maryland, College Park
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 446
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Project HEAL
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
Project HEAL 2.0
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).

Locations

Country Name City State
United States University of Maryland School of Public Health College Park Maryland

Sponsors (4)

Lead Sponsor Collaborator
University of Maryland, College Park Access to Wholistic and Productive Living Institute, American Cancer Society, Inc., Community Ministry of Prince George's County

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Integration of health-relation practices assessed via church survey Intervention impact on institutionalization at 12 and 24 months Change from baseline to 12 and 24 months
Secondary Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs Participants from priority population engaged in intervention Up to 4 months
Secondary Efficacy: Increased knowledge of cancer as assessment by participant surveys Cancer-related knowledge Up to 12 months
Secondary Efficacy: Increased self-report of cancer screening as assessment by participant surveys Self-reported cancer screening Up to 12 months
Secondary Adoption Cooperation rate of churches At recruitment/enrollment
Secondary Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff Adherence to intervention protocol Up to 4 months
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