Back to resultsFaith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
Primary Purpose
Lung Cancer, Cervical Cancer, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lay health advisor interactions
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring Smoking cessation, Cancer screening, Appalachia, Group-randomized trial, Faith-placed
Eligibility 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
Sites / Locations
- Faith Moves Mountains
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Intervention
Delayed Intervention
Arm Description
Participants in this group are nested in churches which were randomly assigned to the treatment group.
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 Outcome Measures
Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)
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
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
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)
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.
Full Information
NCT ID
NCT01373320
First Posted
June 10, 2011
Last Updated
October 21, 2013
Sponsor
Nancy Schoenberg
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT01373320
Brief Title
Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
Official Title
Faith Moves Mountains: A CBPR Appalachian Wellness & Cancer Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nancy Schoenberg
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Cervical Cancer, Breast Cancer, Colorectal Cancer
Keywords
Smoking cessation, Cancer screening, Appalachia, Group-randomized trial, Faith-placed
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1415 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Intervention
Arm Type
Experimental
Arm Description
Participants in this group are nested in churches which were randomly assigned to the treatment group.
Arm Title
Delayed Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lay health advisor interactions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)
Description
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.
Time Frame
Assessed approximately 4 months after baseline
Secondary Outcome Measure Information:
Title
Change in stage of readiness to change the selected health behavior(s) from baseline
Description
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.
Time Frame
Assessed approximately 4 months after baseline
Title
Number of visits completed
Description
This process measure will reflect the number of visits/classes attended by participants, as a means of assessing participation rate and feasibility.
Time Frame
Approximately 4 months after baseline
Title
Retention (i.e., number of participants who complete all planned assessment timepoints)
Description
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.
Time Frame
Approximately one year after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Schoenberg, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faith Moves Mountains
City
Whitesburg
State/Province
Kentucky
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
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