Skip to main content

Summary

Eligibility
for females ages 21–29
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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.

Official Title

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

Details

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) mobile application (APP)-based intervention for providers, or 2) patient-centered approach (PCA) intervention plus APP-based intervention for providers. These groups will be compared to a comparison group of 26 clinics chosen using propensity score matching based on clinic characteristics such as county and private versus public from the Family PACT claims data. The APP 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 PCA intervention will be patients' education and self-assessment using a tablet at the time of check-in to assist in asking questions and evaluating treatment options. The tablet program 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 PCA+APP 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 6 sites (APP) and 7 sites (PCA+APP) 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 (26 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.

Keywords

Cervical Cancer Pap smear Screening Women Human papillomavirus Cervical precancer Guideline adherence

Eligibility

You can join if…

Open to females ages 21–29

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles
    Los Angeles, California, 90095, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02270021
Lead Scientist
Anna-Barbara Moscicki
Study Type
Interventional
Last Updated
July 1, 2017