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
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
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Four tailored newsletters and peer counseling calls to promote CRC screening among church members out-of-date according to screening guidelines.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Among church members who were out-of-date for CRC screening at baseline, a higher percentage of experimental participants will have been screened at the time of follow-up.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
NCT ID
NCT01139242
First Posted
June 4, 2010
Last Updated
June 7, 2010
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention
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
Learn more about this trial
Increasing Colorectal Cancer Screening in Urban African American Communities Via Churches
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