Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program
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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 |
- 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.
- 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.
| Estimated Enrollment: | 1260 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | December 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 |
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
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: | September 18, 2012 |
| 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 May 19, 2013