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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372241
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : April 21, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nancy Schoenberg, University of Kentucky

Brief Summary:
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 or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Lay health advisor visits and newsletter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Appalachian Cervical Cancer Prevention Project
Study Start Date : December 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01372241

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United States, Kentucky
Faith Moves Mountains
Whitesburg, Kentucky, United States
Sponsors and Collaborators
Nancy Schoenberg
National Cancer Institute (NCI)
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Principal Investigator: Nancy Schoenberg, Ph.D. University of Kentucky
Principal Investigator: Mark Dignan, Ph.D. University of Kentucky
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nancy Schoenberg, Sponsor/PI, University of Kentucky Identifier: NCT01372241    
Other Study ID Numbers: R01CA108696 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: June 2011
Keywords provided by Nancy Schoenberg, University of Kentucky:
Papanicolaou test
Cervical cancer screening
Randomized controlled trial
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases