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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01372241
First received: June 8, 2011
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Cervical Cancer
 Behavioral: Lay health advisor visits and newsletter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Appalachian Cervical Cancer Prevention Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Proportion of participants self-reporting receipt of Pap test [ Time Frame: One month post-intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 345
Study Start Date: December 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372241

Locations
United States, Kentucky
Faith Moves Mountains
Whitesburg, Kentucky, United States
Sponsors and Collaborators
University of Kentucky
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nancy Schoenberg, Ph.D. University of Kentucky
Principal Investigator: Mark Dignan, Ph.D. University of Kentucky
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nancy Schoenberg, Ph.D., Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT01372241     History of Changes
Other Study ID Numbers: R01CA108696
Study First Received: June 8, 2011
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Papanicolaou test
Cervical cancer screening
Randomized controlled trial
Faith-placed
Appalachia

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013