Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project (FMM)

April 20, 2017 updated by: Nancy Schoenberg

An Appalachian Cervical Cancer Prevention Project

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Whitesburg, Kentucky, United States
        • Faith Moves Mountains

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Intervention
This group served as the treatment group for analysis of the primary outcome.
Behavioral: Lay health advisor visits and newsletter
The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants self-reporting receipt of Pap test
Time Frame: One month post-intervention
This measure is obtained at multiple timepoints during the study, but as the primary outcome it will be analyzed at the timepoint one month following the Early Intervention group's completion of the intervention.
One month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nancy Schoenberg

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Nancy Schoenberg, Ph.D., University of Kentucky
  • Principal Investigator: Mark Dignan, Ph.D., University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (Estimate)

June 13, 2011

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA108696 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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