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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nancy Schoenberg, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01373320
First received: June 10, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Lung Cancer
Cervical Cancer
Breast Cancer
Colorectal Cancer
Behavioral: Lay health advisor interactions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change in stage of readiness to change the selected health behavior(s) from baseline [ Time Frame: Assessed approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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.

  • Number of visits completed [ Time Frame: Approximately 4 months after baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Approximately one year after baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 1415
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Intervention
Participants in this group are nested in churches which were randomly assigned to the treatment group.
Behavioral: Lay health advisor interactions

For smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor.

For all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening.

No Intervention: Delayed 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373320

Locations
United States, Kentucky
Faith Moves Mountains
Whitesburg, Kentucky, United States
Sponsors and Collaborators
Nancy Schoenberg
Investigators
Principal Investigator: Nancy Schoenberg, Ph.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Nancy Schoenberg, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01373320     History of Changes
Other Study ID Numbers: R24MD002757, R24MD002757
Study First Received: June 10, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Smoking cessation
Cancer screening
Appalachia
Group-randomized trial
Faith-placed

Additional relevant MeSH terms:
Breast Neoplasms
Uterine Cervical Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014