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Increasing Colorectal Cancer Screening in Urban African American Communities Via Churches (ACTS)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Body & Soul nutritional intervention
Experimental: newsletters and peer counseling
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring CRC screening status, physical activity level, fruit and vegetable consumption, Early Detection of Cancer, Colorectal Cancer (CRC) screening status

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Members of African-American churches who are at least 50 years old.

Exclusion Criteria:

  • Non-members of African-American churches; members who are under 50 years of age.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Body & Soul nutritional intervention

    Newsletters/peer counseling

    Arm Description

    This is a standardized intervention to increase fruit and vegetable consumption among church members through pastoral and peer counseling and church activities/menus.

    Four tailored newsletters and peer counseling calls to promote CRC screening among church members out-of-date according to screening guidelines. For those up-to-date, promotion is of increased physical activity.

    Outcomes

    Primary Outcome Measures

    Higher incidence of CRC screening, if needed, among experimental participants.
    Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 4, 2010
    Last Updated
    June 7, 2010
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01139242
    Brief Title
    Increasing Colorectal Cancer Screening in Urban African American Communities Via Churches
    Acronym
    ACTS
    Official Title
    Increasing CRC Screening in Urban African American Communities Via Churches
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an intervention study to increase colorectal cancer screening and physical activity in members of African-American churches who are 50 years old and older. The control arm receives the Body & Soul program, a program to increase fruit and vegetable intake. The investigators hypothesize that those receiving the intervention, which includes four tailored newsletters and peer counseling, will be more likely to be screened if not up-to-date, and more likely to increase physical activity if screening was up-to-date at baseline, than controls.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer
    Keywords
    CRC screening status, physical activity level, fruit and vegetable consumption, Early Detection of Cancer, Colorectal Cancer (CRC) screening status

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    955 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Body & Soul nutritional intervention
    Arm Type
    Other
    Arm Description
    This is a standardized intervention to increase fruit and vegetable consumption among church members through pastoral and peer counseling and church activities/menus.
    Arm Title
    Newsletters/peer counseling
    Arm Type
    Experimental
    Arm Description
    Four tailored newsletters and peer counseling calls to promote CRC screening among church members out-of-date according to screening guidelines. For those up-to-date, promotion is of increased physical activity.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Body & Soul nutritional intervention
    Intervention Description
    Pastoral and peer counseling, and church activities/menus to promote increased fruit and vegetable consumption among church members.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Experimental: newsletters and peer counseling
    Intervention Description
    Four tailored newsletters and peer counseling calls to promote CRC screening in church members who are out-of-date with screening. Four tailored newsletters and peer counseling calls to others to increase physical activity.
    Primary Outcome Measure Information:
    Title
    Higher incidence of CRC screening, if needed, among experimental participants.
    Description
    Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Members of African-American churches who are at least 50 years old. Exclusion Criteria: Non-members of African-American churches; members who are under 50 years of age.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marci K Campbell, PhD
    Organizational Affiliation
    UNC - Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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