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NCT01372241 Clinical Trial

Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project

Cervical Cancer Clinical Trial

— FMM  

Official title:
An Appalachian Cervical Cancer Prevention Project

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01372241
Other study ID # R01CA108696
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated April 20, 2017
Start date December 2005
Est. completion date August 2009

Study information
Verified date June 2011
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 345
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 64 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lay health advisor visits and newsletter
The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.

Locations
Country Name City State
United States Faith Moves Mountains Whitesburg Kentucky

Sponsors (2)
Lead Sponsor Collaborator
Nancy Schoenberg National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. One month post-intervention
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