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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373320
• Other study ID #: R24MD002757
• Secondary ID: R24MD002757
• Status: Completed
• Phase: N/A
• First received: June 10, 2011
• Last updated: October 21, 2013
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1415
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Lung Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Faith Moves Mountains	Whitesburg	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Nancy Schoenberg	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessed approximately 4 months after baseline	No
Secondary	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.	Assessed approximately 4 months after baseline	No
Secondary	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.	Approximately 4 months after baseline	No
Secondary	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.	Approximately one year after baseline	No