- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137683
Colorectal Cancer Control in Appalachian Churches
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Members of church congregations in the Ohio River Valley of West Virginia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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colorectal cancer screening
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Secondary Outcome Measures
Outcome Measure |
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physical activity
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diet
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knowledge
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Irene Tessaro, DrPH, West Virginia University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCDPHP-9998
- U57/CCU320638
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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