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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nancy Schoenberg, University of Kentucky Identifier:
First received: June 8, 2011
Last updated: April 20, 2017
Last verified: June 2011
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Prevention
Official Title: An Appalachian Cervical Cancer Prevention Project

Resource links provided by NLM:

Further study details as provided by Nancy Schoenberg, University of Kentucky:

Primary Outcome Measures:
  • 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.

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.

Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01372241

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nancy Schoenberg, Sponsor/PI, University of Kentucky Identifier: NCT01372241     History of Changes
Other Study ID Numbers: R01CA108696 ( U.S. NIH Grant/Contract )
Study First Received: June 8, 2011
Last Updated: April 20, 2017

Keywords provided by Nancy Schoenberg, University of Kentucky:
Papanicolaou test
Cervical cancer screening
Randomized controlled trial

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female processed this record on July 19, 2017