Overview

This trial is active, not recruiting.

Conditions information dissemination, evidence-based public health
Treatment community health advisor education
Sponsor University of Maryland
Start date March 2011
End date February 2017
Trial size 574 participants
Trial identifier NCT02076958, R01CA147313

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose screening
Arm
(Active Comparator)
Community health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed
community health advisor education
(Experimental)
Community health advisors trained using technology/online methods and provided minimal technical assistance/support
community health advisor education

Primary Outcomes

Measure
Adherence to program delivery protocol - Implementation of the 3-workshop series.
time frame: Up to 10 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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

Additional Information

Official title Implementation of Evidence-Based Cancer Early Detection in Black Churches
Principal investigator Cheryl L Holt, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Maryland.