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

Sponsor

University of Maryland, College Park (Other)

Overall Status

Completed

CT.gov ID

NCT02076958

Collaborator

(none)

457

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Information Dissemination Evidence-Based Public Health	Behavioral: Community Health Advisor education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

457 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

Implementation of Evidence-Based Cancer Early Detection in Black Churches

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Traditional/classroom

Community health advisors trained using traditional/classroom methods and provided with technical assistance/support as needed

Behavioral: Community Health Advisor education

Experimental: Technology

Community health advisors trained using technology/online methods and provided minimal technical assistance/support

Behavioral: Community Health Advisor education

Outcome Measures

Primary Outcome Measures

Adherence to program delivery protocol - Implementation of the 3-workshop series. [Up to 10 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.