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Colorectal Cancer Control in Appalachian Churches

Primary Purpose

Colorectal Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
one-on-one education, group education, small media
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring screening, prevention, community health education

Eligibility Criteria

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

Inclusion Criteria: Members of church congregations in the Ohio River Valley of West Virginia

Sites / Locations

  • West Virginia University

Outcomes

Primary Outcome Measures

colorectal cancer screening

Secondary Outcome Measures

physical activity
diet
knowledge

Full Information

First Posted
August 27, 2005
Last Updated
March 13, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT00137683
Brief Title
Colorectal Cancer Control in Appalachian Churches
Official Title
Colorectal Cancer Control in Appalachian Churches
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
West Virginia University

4. Oversight

5. Study Description

Brief Summary
The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer (CRC) among members of rural Appalachian churches. The sampling frame consists of all of the churches in a 7 county area of western West Virginia. Eligible churches will have at least 180 active members, will not share a common pastor, and will have no CRC control activities. Using a 2x2 experimental design, churches will be divided into two separate clusters, those with and without an existing parish nurse program. Then churches from each cluster will be randomized to one of two conditions, a natural helper or a control condition.
Detailed Description
The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer (CRC) among members of rural Appalachian churches. Many regions of Appalachia have high poverty, low education, and high unemployment. Health disparities are great in this region and social and behavioral factors put many individuals at high risk for increased mortality from CRC. The sampling frame consists of all churches in a 7 county area of western West Virginia. Eligible churches will have at least 180 active members, will not share a common pastor, and have no CRC control activities. Using a 2x2 experimental design, churches will be divided into two separate clusters, those with and without an existing parish nurse program. Then churches from each cluster will be randomized to one of two conditions, a natural helper or control condition. Eligible church members will be adult males and females who are identified through member lists provided by the recruited churches. Because the primary outcome variable is CRC screening, at least half of the recruited church members must be age 50 and older, report no history of CRC, and have not recently completed CRC screening. Interested members will be asked to complete an informed consent form detailing participation in either the intervention or control arm of the study. The control group will be offered other health promotion interventions through the church and the CRC educational materials after data collection is completed. Data will be collected before and after the intervention activities. Study participants will complete a paper and pencil survey at the church at each measurement point (baseline, follow-up). The baseline survey will assess sociodemographics, psychosocial information, stage of change, self-efficacy, health beliefs, barriers to change, health behavior knowledge and practices involving diet, physical activity, and CRC screening. The follow-up survey will assess body mass index, dietary intake, physical activity level, and CRC screening by FOBT, flexible sigmoidoscopy, and colonoscopy. The primary hypothesis to be tested is that the combination of these two community-based intervention strategies will be most effective overall. To evaluate the effectiveness of the intervention strategies, the proportions in outcome measures between each intervention, the combined intervention, and control groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
screening, prevention, community health education

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
one-on-one education, group education, small media
Primary Outcome Measure Information:
Title
colorectal cancer screening
Secondary Outcome Measure Information:
Title
physical activity
Title
diet
Title
knowledge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Members of church congregations in the Ohio River Valley of West Virginia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Tessaro, DrPH
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

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Colorectal Cancer Control in Appalachian Churches

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