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

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01139242
First received: June 4, 2010
Last updated: June 7, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Behavioral: Body & Soul nutritional intervention
Behavioral: Experimental: newsletters and peer counseling
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Increasing CRC Screening in Urban African American Communities Via Churches

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Higher incidence of CRC screening, if needed, among experimental participants. [ Time Frame: One year ] [ Designated as safety issue: No ]
    Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.


Enrollment: 955
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Body & Soul nutritional intervention
This is a standardized intervention to increase fruit and vegetable consumption among church members through pastoral and peer counseling and church activities/menus.
 Behavioral: Body & Soul nutritional intervention
Pastoral and peer counseling, and church activities/menus to promote increased fruit and vegetable consumption among church members.
Experimental: Newsletters/peer counseling
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.
 Behavioral: Experimental: newsletters and peer counseling
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139242

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Marci K Campbell, PhD UNC - Chapel Hill
  More Information

No publications provided

Responsible Party: Marci Campbell, UNC-Chapel Hill
ClinicalTrials.gov Identifier: NCT01139242     History of Changes
Other Study ID Numbers: 05-1271, U48-DP000059-02S1
Study First Received: June 4, 2010
Last Updated: June 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
CRC screening status
physical activity level
fruit and vegetable consumption
Early Detection of Cancer
Colorectal Cancer (CRC) screening status

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013