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Clinical Trials/NCT01373320
NCT01373320CompletedNot Applicable

Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program

Nancy Schoenberg1 site in 1 country1,415 target enrollmentStarted: March 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,415
Locations
1
Primary Endpoint
Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Early Intervention

Experimental

Participants in this group are nested in churches which were randomly assigned to the treatment group.

Intervention: Lay health advisor interactions (Behavioral)

Delayed Intervention

No Intervention

Participants in this group are nested in churches which were randomly assigned to the wait-list control group. They receive an educational luncheon focused on stress reduction during the intervention window for the Early Intervention group, and subsequently receive the intervention(s) for their selected target health behaviors at a later date.

Outcomes

Primary Outcomes

Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)

Time Frame: 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 Outcomes

  • Number of visits completed(Approximately 4 months after baseline)
  • Retention (i.e., number of participants who complete all planned assessment timepoints)(Approximately one year after baseline)
  • Change in stage of readiness to change the selected health behavior(s) from baseline(Assessed approximately 4 months after baseline)

Investigators

Sponsor
Nancy Schoenberg
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Nancy Schoenberg

Sponsor/PI

University of Kentucky

Study Sites (1)

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