Intervention to Improve Follow-up of Abnormal Pap Test

Study Overview
=================
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.

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.

Official Title
-----------------
Intervention to Improve Follow-up of Abnormal Pap Test

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Behavioral: Intervention
* Behavioral: Active control


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling | Behavioral: Intervention<br>* Multiple component intervention based in the unified theory of behavior<br>|
| Active Comparator: Active Control<br>nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling | Behavioral: Active control<br>* Partial intervention (full intervention minus cultural-specific component)<br>|
| No Intervention: Standard Care Only<br>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) | 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 | State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels) | + 7-30 days post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unified theory of behavior, Pap test, cervical dysplasia, women's health