Clinical trial NCT01373320: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Cervical Cancer
Breast Cancer
Colorectal Cancer
Keywords: Smoking cessation
Cancer screening
Appalachia
Group-randomized trial
Faith-placed
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2011-06-14
Enrollment: 1415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proportion of participants reporting the health behavior of interest (depending on which intervention component(s) were selected)
timeFrame: Assessed approximately 4 months after baseline
Secondary outcomes:
measure: Change in stage of readiness to change the selected health behavior(s) from baseline
timeFrame: Assessed approximately 4 months after baseline
measure: Number of visits completed
timeFrame: Approximately 4 months after baseline
measure: Retention (i.e., number of participants who complete all planned assessment timepoints)
timeFrame: Approximately one year after baseline
Other outcomes:
Locations:
city: Whitesburg
country: United States
facility: Faith Moves Mountains
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Nancy Schoenberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: