Intervention to Improve Follow-up of Abnormal Pap Test
2 other identifiers
interventional
341
1 country
1
Brief Summary
This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
1 active site
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
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
August 15, 2014
CompletedAugust 23, 2018
July 1, 2018
6.5 years
December 14, 2007
May 19, 2014
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to Initial Follow-up (Yes/no)
Attendance at initial appointment to follow-up abnormal Pap test result
adherence rates at initial follow-up appointment, 2 weeks to 3 months
Secondary Outcomes (1)
State Trait Anxiety Inventory (STAI)-State Scale
+ 7-30 days post-intervention
Study Arms (3)
Intervention
EXPERIMENTALCulturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Active Control
ACTIVE COMPARATORnontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Standard Care Only
NO INTERVENTIONClinical standard of care at time of study
Interventions
Multiple component intervention based in the unified theory of behavior
Partial intervention (full intervention minus cultural-specific component)
Eligibility Criteria
You may qualify if:
- Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
You may not qualify if:
- Women who are currently pregnant
- Have a current diagnosis of cervical cancer; or
- Who are unable to understand English or Spanish.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Related Publications (1)
Breitkopf CR, Dawson L, Grady JJ, Breitkopf DM, Nelson-Becker C, Snyder RR. Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial. Health Psychol. 2014 Apr;33(4):307-316. doi: 10.1037/a0032722. Epub 2013 Jun 3.
PMID: 23730719RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carmen Radecki Breitkopf
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen R Breitkopf, PhD
University of Texas Medical Branch, Galveston
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
October 1, 2005
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
August 23, 2018
Results First Posted
August 15, 2014
Record last verified: 2018-07