Intervention to Improve Follow-up of Abnormal Pap Test
July 25, 2018 updated by: The University of Texas Medical Branch, Galveston
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions.
However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care.
This is a problem especially among minorities and women of lower socioeconomic status.
The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test.
The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients.
The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control).
All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up.
Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities.
Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up.
Adherence to initial follow-up will be the primary outcome.
Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review.
Additionally, the investigators will evaluate psychological outcomes including anxiety and distress.
Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier.
The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results.
The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results.
Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.
Study Type
Interventional
Enrollment (Actual)
341
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- University of Texas Medical Branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
Exclusion Criteria:
- Women who are currently pregnant
- Have a current diagnosis of cervical cancer; or
- Who are unable to understand English or Spanish.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Multiple component intervention based in the unified theory of behavior
|
|
Active Comparator: Active Control
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Partial intervention (full intervention minus cultural-specific component)
|
|
No Intervention: Standard Care Only
Clinical standard of care at time of study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to Initial Follow-up (Yes/no)
Time Frame: adherence rates at initial follow-up appointment, 2 weeks to 3 months
|
Attendance at initial appointment to follow-up abnormal Pap test result
|
adherence rates at initial follow-up appointment, 2 weeks to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Trait Anxiety Inventory (STAI)-State Scale
Time Frame: + 7-30 days post-intervention
|
State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)
|
+ 7-30 days post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Carmen R Breitkopf, PhD, University of Texas Medical Branch, Galveston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 17, 2007
First Posted (Estimate)
December 18, 2007
Study Record Updates
Last Update Posted (Actual)
August 23, 2018
Last Update Submitted That Met QC Criteria
July 25, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-245
- R01CA107015 (U.S. NIH Grant/Contract)
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