Decreasing Over Screening and Treatment of Cervical Precancers in Young Women

September 23, 2019 updated by: University of California, San Francisco

Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women

The goal of this study is to prevent over screening and over treatment of young women for cervical precancers, which can result in psychological distress and has been associated with future risk of premature deliveries. Current national guidelines recommend that routine screening be performed at less-frequent intervals and that excisional cervical therapies are discouraged in young women. The objectives of this study are to examine physician- and patient-based interventions designed to decrease over screening and over treatment by increasing adherence to US guidelines for women under 30 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, we compare two different intervention arms that are designed to prevent over screening and over treatment by increasing adherence to the new US cervical cancer screening guidelines and the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Specifically, the interventions will focus on the newly recommended cervical cancer screening intervals and decreasing the number of colposcopy procedures and cervical procedures for abnormal cytology.

This is a cluster randomized trial with individual clinics serving as the clusters. Clinics from the California Family PACT provider network who serve at least 200 female clients per year under 30 years of age will be randomized to one of two arms: 1) ASCCP mobile application (ProvAPP)-based intervention for providers, or 2) ProvAPP + Patient education Tool (Tab) intervention. These groups will be compared to a control comparison group of 28 clinics chosen using propensity score matching based on clinic characteristics such as county and private versus public from the Family PACT claims data. The ProvAPP intervention is for clinicians' mobile phones and will help them maneuver through current guidelines based on patient age and condition. An existing application from the ASCCP will be updated to include screening guidelines and to be more user-friendly. The patient-based Tab intervention will be a patient education tool accessible via URL on a tablet device at the time of check-in to assist in asking questions and evaluating treatment options. The tool will be developed with input from women age 21-29 as well as other stakeholders including Latinas Contra Cancer and the National Cervical Cancer Coalition. It is hypothesized that the ProvAPP+Tab approach will be most successful; all interventions will be more successful than no intervention.

Family PACT serves predominantly uninsured women and 40% of clients are Latina. We plan to enroll 7 sites (ProvAPP) and 7 sites (ProvAPP+Tab) into the other intervention arm with an average of 2,800 women to 3,500 women aged 21-29 years per arm (14 sites) with a similar number of sites and women randomly chosen for the comparison arm (28 sites) resulting in a total of 39 sites and 8,400-10,500 women. We will use Family PACT claims data to examine, by age, the number of and average interval between cytology specimens, colposcopy examinations, and the number of excisional procedures.

Study Type

Interventional

Enrollment (Actual)

42

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

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

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

21 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria - Patients:

  • English or Spanish speaking
  • Women
  • Age 21-29 years
  • History of one or more of the following: abnormal Pap smear, normal Pap smear, no Pap smear, cervical cancer

Exclusion Criteria - Patients:

  • Language other than English or Spanish
  • Male
  • Younger than 21 or older than 29

Inclusion Criteria - Clinics:

  • Family PACT provider
  • Not a Planned Parenthood affiliate
  • Located in one of ten identified Southern California study counties
  • Sends cytology/histology specimens to Quest Diagnostics West Hills
  • Clinical care visits occurred to at least 200 women age 21-29 years in fiscal year 2011/2012
  • Has a calculated average cytology interval of less than 30 months (based on last three years)

Exclusion Criteria - Clinics:

  • Not a Family PACT provider
  • Planned Parenthood affiliate
  • Not located in one of ten identified Southern California study counties
  • Sends cytology/histology specimens to a lab other than Quest Diagnostics West Hills
  • Clinical care visit occurred to less than 200 women age 21-29
  • Has a calculated average cytology interval of more than 30 months

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Provider Mobile Application (ProvAPP)
Mobile phone application for providers.
Other: Provider Mobile Application (ProvAPP)
Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
Experimental: ProvAPP + Patient Educational Tool (Tab)
Patient educational tool; plus the Mobile phone application for providers.
Other: ProvAPP + Patient Educational Tool (Tab)

Patient Educational Tool (Tab): A patient educational tool (mobile tablet) will educate women on cervical cancer screening and treatment. Patients' self-assessment using a tablet at the time of clinic check-in will help them to understand current guidelines and their choices for treatment if they have abnormal cytology. It will allow them to assess the risks and benefits of screening intervals and of treatment choices.

ProvAPP: Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
No Intervention: ProvAPP Control Group
Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data.
No Intervention: ProvAPP+Tab Control Group
Clinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Cervical Cancer Screening
Time Frame: Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention
Rate of women 21-29 years who received cervical cytology tests.
Change from baseline screening rate (3 months prior to intervention) to 15-18 months after start of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Colposcopy
Time Frame: Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention
Rate of women 21-29 years who receive colposcopy for cervical cancer screening over the total number of women 21-29 years.
Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Patient-Centered Outcomes Research Institute
American College of Obstetricians and Gynecologists
California Department of Health Services
Latinas Contra Cancer
National Cervical Cancer Coalition
American Society for Colposcopy and Cervical Pathology

Investigators

  • Principal Investigator: Anna-Barbara Moscicki, MD, University of California, San Francisco

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.

General Publications

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 (Actual)

July 24, 2014

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-12257
  • CD-1304-6551 (Other Grant/Funding Number: PCORI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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