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Completed

NCT Number: NCT02076958

Implementation of Evidence-Based Cancer Early Detection in Black Churches

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Public Health

College Park, Maryland, 20742, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Health Advisor education

Behavioral

Primary outcomes

  1. Adherence to program delivery protocol - Implementation of the 3-workshop series.

    Time frame: Up to 10 months

Secondary outcomes

  1. Number of training events (workshops)

    Time frame: Up to 10 months

  2. Number of CHA trainees

    Time frame: Baseline

  3. Completion of CHA training

    Time frame: Baseline

  4. Self-report of modifications or problems with program delivery

    Time frame: Up to 12 months

  5. Number of booster CHA training sessions over two-year period

    Time frame: 12-month; 24-month

  6. Change in number of survey completion from baseline to 12-month to 24-month

    Time frame: Baseline; 12-month; 24-month

  7. Number of educational sessions participants attended

    Time frame: Up to 10 months

  8. Change in knowledge of cancer early detection from workshop 1 to workshop 3

    Time frame: Up to 10 months

  9. Change in perceived benefits of screening

    Time frame: Up to 10 months

  10. Change in perceived barriers to screening

    Time frame: Up to 10 months

  11. Change in self-efficacy for screening

    Time frame: Up to 10 months

  12. Change in self-report of screening from baseline to 12-month to 24-month

    Time frame: Baseline; 12-month; 24-month

  13. Ratings of program

    Time frame: Up to 10 months

  14. Percent of eligible congregation that enrolled in the project

    Time frame: Baseline

  15. Number of participants that attended educational sessions

    Time frame: Up to 10 months

  16. Enrollment of churches

    Time frame: Baseline

    Number agreed/total approached

  17. Number of additional training cycles completed over two year period

    Time frame: 12-months; 24-months

  18. Amount of supplemental funding church receives for additional health education over two years

    Time frame: 12-month; 24-month

  19. Number of continued health education activities including cancer education over two year period

    Time frame: 12-month; 24-month

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Registry information

Acronym: Project HEAL

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2014
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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