Implementation of Evidence-Based Cancer Early Detection in Black Churches

Information Dissemination Clinical Trial

— Project HEAL  

Official title:

Implementation of Evidence-Based Cancer Early Detection in Black Churches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076958
• Other study ID #: R01CA147313
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: October 2018

Study information

• Verified date: May 2022
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

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

• 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

Related Conditions & MeSH terms

• Evidence-Based Public Health
• Information Dissemination

Intervention

Behavioral:
• Community Health Advisor education

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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

External Links

•   Community Health Awareness, Messages and Prevention (CHAMP) Lab