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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Maryland
ClinicalTrials.gov Identifier:
NCT02076958
First received: February 27, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 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 Intervention
Information Dissemination
Evidence-Based Public Health
Behavioral: Community Health Advisor education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Implementation of Evidence-Based Cancer Early Detection in Black Churches

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Adherence to program delivery protocol - Implementation of the 3-workshop series. [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of training events (workshops) [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Number of CHA trainees [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Completion of CHA training [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Self-report of modifications or problems with program delivery [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of booster CHA training sessions over two-year period [ Time Frame: 12-month; 24-month ] [ Designated as safety issue: No ]
  • Change in number of survey completion from baseline to 12-month to 24-month [ Time Frame: Baseline; 12-month; 24-month ] [ Designated as safety issue: No ]
  • Number of educational sessions participants attended [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Change in knowledge of cancer early detection from workshop 1 to workshop 3 [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Change in perceived benefits of screening [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Change in perceived barriers to screening [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Change in self-efficacy for screening [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Change in self-report of screening from baseline to 12-month to 24-month [ Time Frame: Baseline; 12-month; 24-month ] [ Designated as safety issue: No ]
  • Ratings of program [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Percent of eligible congregation that enrolled in the project [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of participants that attended educational sessions [ Time Frame: Up to 10 months ] [ Designated as safety issue: No ]
  • Enrollment of churches [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Number agreed/total approached

  • Number of additional training cycles completed over two year period [ Time Frame: 12-months; 24-months ] [ Designated as safety issue: No ]
  • Amount of supplemental funding church receives for additional health education over two years [ Time Frame: 12-month; 24-month ] [ Designated as safety issue: No ]
  • Number of continued health education activities including cancer education over two year period [ Time Frame: 12-month; 24-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 574
Study Start Date: March 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076958

Locations
United States, Maryland
University of Maryland School of Public Health
College Park, Maryland, United States, 20742
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Cheryl L Holt, PhD University of Maryland School of Public Health
  More Information

Additional Information:
No publications provided

Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT02076958     History of Changes
Other Study ID Numbers: R01CA147313
Study First Received: February 27, 2014
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Implementation
Cancer
Early detection
Faith-based
Community health advisor

ClinicalTrials.gov processed this record on September 22, 2014