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

NCT ID: NCT01373320

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer Cervical Cancer Breast Cancer Colorectal Cancer

Keywords

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Smoking cessation Cancer screening Appalachia Group-randomized trial Faith-placed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Early Intervention

Participants in this group are nested in churches which were randomly assigned to the treatment group.

Group Type EXPERIMENTAL

Lay health advisor interactions

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Nancy Schoenberg

OTHER

Sponsor Role lead

Responsible Party

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Nancy Schoenberg

Sponsor/PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nancy Schoenberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Faith Moves Mountains

Whitesburg, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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R24MD002757

Identifier Type: NIH

Identifier Source: secondary_id

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R24MD002757

Identifier Type: NIH

Identifier Source: org_study_id

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