NCT03178383

Brief Summary

The proposed project will compare two ways to apply a known-effective cancer educational strategy through African American churches: 1) a standard method vs. 2) a new method in which the churches integrate the strategy into their organizational structure and practice at multiple levels. It will be determined whether this "integrated approach" results in more effective and sustained cancer education and screening activities at both the church and individual levels over time. This project will make important contributions to research in evidence-based medicine and sustainability. In a climate of limited resources, identifying sustainable and effective ways to increase cancer awareness and screening in African American men and women is more important than ever.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
446

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

6 years

First QC Date

May 18, 2017

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Integration of health-relation practices assessed via church survey

    Intervention impact on institutionalization at 12 and 24 months

    Change from baseline to 12 and 24 months

Secondary Outcomes (5)

  • Reach: Number of participants from priority population engaged in intervention as assessed by enrollment logs

    Up to 4 months

  • Efficacy: Increased knowledge of cancer as assessment by participant surveys

    Up to 12 months

  • Efficacy: Increased self-report of cancer screening as assessment by participant surveys

    Up to 12 months

  • Adoption

    At recruitment/enrollment

  • Implementation: Extent to which intervention is implemented as intended as assessed by a fidelity checklist completed by staff

    Up to 4 months

Study Arms (2)

Integrated Approach

EXPERIMENTAL

In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g. men's, women's, seniors).

Behavioral: Project HEAL 2.0

Standard Comparison

ACTIVE COMPARATOR

Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.

Behavioral: Project HEAL

Interventions

Project HEALBEHAVIORAL

Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.

Standard Comparison

In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g. men's, women's, seniors).

Integrated Approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Adults ages 21+
  • Regularly attend church services
  • Able to complete Project HEAL training
  • Able to recruit 40+ participants for a breast, prostate, or colorectal cancer educational workshop
  • Able to lead the breast, prostate, and colorectal cancer workshops
  • Workshop Participants
  • Self-identified African American
  • Adults ages 21+
  • Have no history of breast, prostate, or colorectal cancer

You may not qualify if:

  • Workshop Participants: Men and women who have had breast, prostate, or colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Public Health

College Park, Maryland, 20742, United States

Location

Related Publications (2)

  • Knott CL, Chen C, Bowie JV, Mullins CD, Slade JL, Woodard N, Robinson-Shaneman BR, Okwara L, Huq MR, Williams R, He X. Cluster-randomized trial comparing organizationally tailored versus standard approach for integrating an evidence-based cancer control intervention into African American churches. Transl Behav Med. 2022 May 26;12(5):673-682. doi: 10.1093/tbm/ibab088.

  • Knott CL, Bowie J, Mullins CD, Santos SLZ, Slade J, Rosenberg E, Woodard N, Williams R, Williams RM. An Approach to Adapting a Community-Based Cancer Control Intervention to Organizational Context. Health Promot Pract. 2020 Mar;21(2):168-171. doi: 10.1177/1524839919898209. Epub 2020 Jan 20.

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Cheryl L Holt, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

June 6, 2017

Study Start

July 1, 2016

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations