Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project

NCT ID: NCT01372241

Last Updated: 2017-04-21

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

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.

Detailed Description

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Project development relied on principles of community based participatory research. Participants were recruited from faith institutions in four distressed Appalachian Kentucky counties. Investigators at the University of Kentucky worked closely with local staff who implemented study procedures in the field.

Conditions

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Cervical Cancer

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

This group served as the treatment group for analysis of the primary outcome.

Group Type EXPERIMENTAL

Lay health advisor visits and newsletter

Intervention Type BEHAVIORAL

The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.

Delayed Intervention

This group served as a wait-list control group, eventually receiving the intervention after the treatment group completed the intervention and the primary outcomes were assessed for both groups.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lay health advisor visits and newsletter

The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Outside of cervical cancer screening guidelines at the time of study initiation
* Able to provide informed consent

Exclusion Criteria

* History of cervical cancer
* History of hysterectomy
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

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

Mark Dignan, 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

References

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Schoenberg NE, Hatcher J, Dignan MB, Shelton B, Wright S, Dollarhide KF. Faith Moves Mountains: an Appalachian cervical cancer prevention program. Am J Health Behav. 2009 Nov-Dec;33(6):627-38. doi: 10.5993/ajhb.33.6.1.

Reference Type BACKGROUND
PMID: 19320612 (View on PubMed)

Studts CR, Tarasenko YN, Schoenberg NE, Shelton BJ, Hatcher-Keller J, Dignan MB. A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia. Prev Med. 2012 Jun;54(6):408-14. doi: 10.1016/j.ypmed.2012.03.019. Epub 2012 Apr 3.

Reference Type DERIVED
PMID: 22498022 (View on PubMed)

Other Identifiers

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R01CA108696

Identifier Type: NIH

Identifier Source: org_study_id

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