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Integration of Cancer Health Activities Into African American Churches

Primary Purpose

Breast Cancer, Prostate Cancer, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project HEAL
Project HEAL 2.0
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Approach

Standard Comparison

Arm Description

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).

Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.

Outcomes

Primary Outcome Measures

Integration of health-relation practices assessed via church survey
Intervention impact on institutionalization at 12 and 24 months

Secondary Outcome Measures

Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Participants from priority population engaged in intervention
Efficacy: Increased knowledge of cancer as assessment by participant surveys
Cancer-related knowledge
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Self-reported cancer screening
Adoption
Cooperation rate of churches
Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff
Adherence to intervention protocol

Full Information

First Posted
May 18, 2017
Last Updated
October 31, 2022
Sponsor
University of Maryland, College Park
Collaborators
American Cancer Society, Inc., Community Ministry of Prince George's County, Access to Wholistic and Productive Living Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03178383
Brief Title
Integration of Cancer Health Activities Into African American Churches
Official Title
Integration of Cancer Health Activities Into African American Churches
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
American Cancer Society, Inc., Community Ministry of Prince George's County, Access to Wholistic and Productive Living Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Colorectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Approach
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard Comparison
Arm Type
Active Comparator
Arm Description
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
Intervention Type
Behavioral
Intervention Name(s)
Project HEAL
Intervention Description
Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
Intervention Type
Behavioral
Intervention Name(s)
Project HEAL 2.0
Intervention Description
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).
Primary Outcome Measure Information:
Title
Integration of health-relation practices assessed via church survey
Description
Intervention impact on institutionalization at 12 and 24 months
Time Frame
Change from baseline to 12 and 24 months
Secondary Outcome Measure Information:
Title
Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs
Description
Participants from priority population engaged in intervention
Time Frame
Up to 4 months
Title
Efficacy: Increased knowledge of cancer as assessment by participant surveys
Description
Cancer-related knowledge
Time Frame
Up to 12 months
Title
Efficacy: Increased self-report of cancer screening as assessment by participant surveys
Description
Self-reported cancer screening
Time Frame
Up to 12 months
Title
Adoption
Description
Cooperation rate of churches
Time Frame
At recruitment/enrollment
Title
Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff
Description
Adherence to intervention protocol
Time Frame
Up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl L Holt, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Public Health
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34255087
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.
Results Reference
derived
PubMed Identifier
31959002
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.
Results Reference
derived
Links:
URL
http://bit.ly/CHAMPLab
Description
CHAMP Lab Website

Learn more about this trial

Integration of Cancer Health Activities Into African American Churches

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