Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program

Not Applicable

Completed

• Conditions: Lung Cancer; Cervical Cancer; Breast Cancer; Colorectal Cancer
• Interventions: Behavioral: Lay health advisor interactions

• Registration Number: NCT01373320
• Lead Sponsor: Nancy Schoenberg

Brief Summary

The study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants.

Detailed Description

The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to cancer prevention. In the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1415

Inclusion Criteria

• For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent
• For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent
• For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent
• For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent

Exclusion Criteria

• For smoking cessation: None
• For cervical cancer screening: History of cervical cancer; history of hysterectomy
• For breast cancer screening: History of breast cancer
• For colorectal cancer screening: History of colorectal cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Intervention	Lay health advisor interactions	Participants in this group are nested in churches which were randomly assigned to the treatment group.

Primary Outcome Measures

Name	Time	Method
Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)	Assessed approximately 4 months after baseline	For smoking cessation: Self-reported smoking status. For cancer screenings: Self-reported receipt of cervical, breast, and/or colorectal cancer screening. This assessment occurs after the Early Treatment group has completed the intervention.

Secondary Outcome Measures

Name	Time	Method
Number of visits completed	Approximately 4 months after baseline	This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.
Retention (i.e., number of participants who complete all planned assessment timepoints)	Approximately one year after baseline	Retention numbers will be assessed as a process measure outcome. Participants who complete all study assessment timepoints will be coded as "1," while participants who drop out will be coded "0." Number/percentage of participants who remained enrolled and complete all study procedures and assessments will be used as an indicator of feasibility in the community setting.
Change in stage of readiness to change the selected health behavior(s) from baseline	Assessed approximately 4 months after baseline	Measured using reliable and valid instruments which were pretested in focus groups comprised of members of the target population. Positive change (i.e., increasing stage of readiness) from baseline to post-test will be coded as "1," while negative or no change will be coded "0." This assessment occurs after the Early Treatment group has completed the intervention.

Trial Locations

Locations (1)

Faith Moves Mountains; 🇺🇸 Whitesburg, Kentucky, United States