NCT01372241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
Last Updated

April 21, 2017

Status Verified

June 1, 2011

Enrollment Period

3.7 years

First QC Date

June 8, 2011

Last Update Submit

April 20, 2017

Conditions

Cervical Cancer

Keywords

Papanicolaou testCervical cancer screeningRandomized controlled trialFaith-placedAppalachia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Early Intervention

EXPERIMENTAL

This group served as the treatment group for analysis of the primary outcome.

Behavioral: Lay health advisor visits and newsletter

Delayed Intervention

NO 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.

Interventions

Lay health advisor visits and newsletterBEHAVIORAL

The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.

Early Intervention

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Outside of cervical cancer screening guidelines at the time of study initiation
  • Able to provide informed consent

You may not qualify if:

  • History of cervical cancer
  • History of hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faith Moves Mountains

Whitesburg, Kentucky, United States

Location

Related Publications (2)

  • 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.

    PMID: 19320612BACKGROUND

  • 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.

    PMID: 22498022DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nancy Schoenberg, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Mark Dignan, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor/PI

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 13, 2011

Study Start

December 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 21, 2017

Record last verified: 2011-06

Locations

US(1)