- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076958
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
Status
Completed
Intervention / Treatment
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
- Holt CL, Tagai EK, Scheirer MA, Santos SL, Bowie J, Haider M, Slade JL, Wang MQ, Whitehead T. Translating evidence-based interventions for implementation: Experiences from Project HEAL in African American churches. Implement Sci. 2014 May 31;9:66. doi: 10.1186/1748-5908-9-66.
- Santos SL, Tagai EK, Wang MQ, Scheirer MA, Slade JL, Holt CL. Feasibility of a web-based training system for peer community health advisors in cancer early detection among african americans. Am J Public Health. 2014 Dec;104(12):2282-9. doi: 10.2105/AJPH.2014.302237. Epub 2014 Oct 16.
- Holt CL, Shelton RC, Allen JD, Bowie J, Jandorf L, Zara Santos SL, Slade J. Development of tailored feedback reports on organizational capacity for health promotion in African American churches. Eval Program Plann. 2018 Oct;70:99-106. doi: 10.1016/j.evalprogplan.2018.07.002. Epub 2018 Jul 21.
- Holt CL, Tagai EK, Santos SLZ, Scheirer MA, Bowie J, Haider M, Slade J. Web-based versus in-person methods for training lay community health advisors to implement health promotion workshops: participant outcomes from a cluster-randomized trial. Transl Behav Med. 2019 Jul 16;9(4):573-582. doi: 10.1093/tbm/iby065.
- Scheirer MA, Santos SL, Tagai EK, Bowie J, Slade J, Carter R, Holt CL. Dimensions of sustainability for a health communication intervention in African American churches: a multi-methods study. Implement Sci. 2017 Mar 28;12(1):43. doi: 10.1186/s13012-017-0576-x.
- Santos SL, Tagai EK, Scheirer MA, Bowie J, Haider M, Slade J, Wang MQ, Holt CL. Adoption, reach, and implementation of a cancer education intervention in African American churches. Implement Sci. 2017 Mar 14;12(1):36. doi: 10.1186/s13012-017-0566-z.
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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