Back to resultsFaith Moves Mountains: An Appalachian Cervical Cancer Prevention Project (FMM)
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lay health advisor visits and newsletter
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring Papanicolaou test, Cervical cancer screening, Randomized controlled trial, Faith-placed, Appalachia
Eligibility 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
Sites / Locations
- Faith Moves Mountains
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Intervention
Delayed Intervention
Arm Description
This group served as the treatment group for analysis of the primary outcome.
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.
Outcomes
Primary Outcome Measures
Proportion of participants self-reporting receipt of Pap test
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01372241
First Posted
June 8, 2011
Last Updated
April 20, 2017
Sponsor
Nancy Schoenberg
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01372241
Brief Title
Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project
Acronym
FMM
Official Title
An Appalachian Cervical Cancer Prevention Project
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nancy Schoenberg
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Papanicolaou test, Cervical cancer screening, Randomized controlled trial, Faith-placed, Appalachia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
345 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Intervention
Arm Type
Experimental
Arm Description
This group served as the treatment group for analysis of the primary outcome.
Arm Title
Delayed Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lay health advisor visits and newsletter
Intervention Description
The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.
Primary Outcome Measure Information:
Title
Proportion of participants self-reporting receipt of Pap test
Description
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.
Time Frame
One month post-intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Schoenberg, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Dignan, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faith Moves Mountains
City
Whitesburg
State/Province
Kentucky
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19320612
Citation
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.
Results Reference
background
PubMed Identifier
22498022
Citation
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.
Results Reference
derived
Learn more about this trial
Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project
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