Implementation of Evidence-Based Cancer Early Detection in Black Churches (Project HEAL)

May 16, 2022 updated by: University of Maryland, College Park
The aim of the proposed project is to identify an optimal implementation strategy using a set of evidence-based interventions that aim to increase early detection of breast, prostate, and colorectal cancer among African Americans as a model. These three interventions will be packaged and interwoven into a single branded project, Project HEAL (Health through Early Awareness and Learning) which will be delivered through trained Community Health Advisors (CHA) in African-American church settings. The implementation and sustainability will be evaluated using the RE-AIM Framework. Fourteen African American churches in Prince George's County, MD will be randomized to a traditional classroom training approach or an online training approach, in which the CHA training approach and level of technical assistance is varied (in-person classroom training of CHAs + monitoring/evaluation + technical assistance and training vs. online training of CHAs + monitoring and evaluation only, respectively). By varying the training methodology and level of technical assistance, we will be able to determine what level of technical assistance leads to successful implementation and sustainability. We will also identify church organizational capacity characteristics that lead to successful implementation and sustainability. The specific aims of this research are to: (1) Package the three interventions into a single branded project (Project HEAL), develop a local cancer screening resource guide, and pilot test the materials and training. (2) Implement Project HEAL in 14 churches in Prince George's County, Maryland. We will evaluate the implementation outcomes involving treatment fidelity and identify church organizational capacity characteristics that led to successful implementation. We will compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance necessary for successful implementation. (3) Evaluate the sustainability of Project HEAL over a two-year period of time. We will identify church organizational capacity characteristics that led to sustainability, and compare the two implementation strategies (traditional vs. online) to determine the optimal level of technical assistance for successful sustainability.

Study Overview

Study Type

Interventional

Enrollment (Actual)

457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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
    • over 21 years of age
    • regularly attend church services
    • able to complete Project HEAL training
    • have regular access to the Internet and feel comfortable completing online training activities
    • able to recruit 30 participants for the 3-part workshop series
    • able to lead the 3-part workshop series
  • Workshop participants: Self-identified African American men and women ages 40-75 for women who are able to complete self-administered paper-and-pencil surveys.

Exclusion Criteria:

  • Workshop participants: Men and women who have had breast, prostate, or colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional/classroom
Community health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed
Experimental: Technology
Community health advisors trained using technology/online methods and provided minimal technical assistance/support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to program delivery protocol - Implementation of the 3-workshop series.
Time Frame: Up to 10 months
Up to 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of training events (workshops)
Time Frame: Up to 10 months
Up to 10 months
Number of CHA trainees
Time Frame: Baseline
Baseline
Completion of CHA training
Time Frame: Baseline
Baseline
Self-report of modifications or problems with program delivery
Time Frame: Up to 12 months
Up to 12 months
Number of booster CHA training sessions over two-year period
Time Frame: 12-month; 24-month
12-month; 24-month
Change in number of survey completion from baseline to 12-month to 24-month
Time Frame: Baseline; 12-month; 24-month
Baseline; 12-month; 24-month
Number of educational sessions participants attended
Time Frame: Up to 10 months
Up to 10 months
Change in knowledge of cancer early detection from workshop 1 to workshop 3
Time Frame: Up to 10 months
Up to 10 months
Change in perceived benefits of screening
Time Frame: Up to 10 months
Up to 10 months
Change in perceived barriers to screening
Time Frame: Up to 10 months
Up to 10 months
Change in self-efficacy for screening
Time Frame: Up to 10 months
Up to 10 months
Change in self-report of screening from baseline to 12-month to 24-month
Time Frame: Baseline; 12-month; 24-month
Baseline; 12-month; 24-month
Ratings of program
Time Frame: Up to 10 months
Up to 10 months
Percent of eligible congregation that enrolled in the project
Time Frame: Baseline
Baseline
Number of participants that attended educational sessions
Time Frame: Up to 10 months
Up to 10 months
Enrollment of churches
Time Frame: Baseline
Number agreed/total approached
Baseline
Number of additional training cycles completed over two year period
Time Frame: 12-months; 24-months
12-months; 24-months
Amount of supplemental funding church receives for additional health education over two years
Time Frame: 12-month; 24-month
12-month; 24-month
Number of continued health education activities including cancer education over two year period
Time Frame: 12-month; 24-month
12-month; 24-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cheryl L Holt, PhD, University of Maryland School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • R01CA147313 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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