Colorectal Cancer Control in Appalachian Churches

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Control in Appalachian Churches

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00137683
• Other study ID #: CDC-NCCDPHP-9998
• Secondary ID: U57/CCU320638
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: August 27, 2005
• Last updated: March 13, 2012
• Start date: September 2001
• Est. completion date: March 2005

Study information

• Verified date: March 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Members of church congregations in the Ohio River Valley of West Virginia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• one-on-one education, group education, small media

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorectal cancer screening
Secondary	physical activity
Secondary	diet
Secondary	knowledge