Clinical trial NCT03178383: Integration of Cancer Health Activities Into African American Churches
Official title: Integration of Cancer Health Activities Into African American Churches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Colorectal Cancer
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Community Ministry of Prince George's County
name: Access to Wholistic and Productive Living Institute
First posted: 2017-06-06
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Integration of health-relation practices assessed via church survey
timeFrame: Change from baseline to 12 and 24 months
Secondary outcomes:
measure: Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
timeFrame: Up to 4 months
measure: Efficacy: Increased knowledge of cancer as assessment by participant surveys
timeFrame: Up to 12 months
measure: Efficacy: Increased self-report of cancer screening as assessment by participant surveys
timeFrame: Up to 12 months
measure: Adoption
timeFrame: At recruitment/enrollment
measure: Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: College Park
country: United States
facility: University of Maryland School of Public Health
state: Maryland
Study officials:
affiliation: Professor
name: Cheryl L Holt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.