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Trial record 2 of 447 for:    cervical cancer University of California

Decreasing Over Screening and Treatment of Cervical Precancers in Young Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Latinas Contra Cancer
National Cervical Cancer Coalition
California Department of Health Services
American College of Obstetricians and Gynecologists
American Society for Colposcopy and Cervical Pathology
Quest Diagnostics
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02270021
First received: October 14, 2014
Last updated: December 1, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention
Cervical Cancer
Device: Mobile Application (APP)
Device: Patient-Centered Approach (PCA) + APP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Rate of Cervical Cancer Screening [ Time Frame: Change from baseline screening rate (3 months prior to intervention) to 3-6 months after start of intervention ]
    Rate of women 21-29 years who received cervical cytology tests over the total number of women 21-29 years.

  • Rate of Cervical Cancer Screening [ Time Frame: Change from baseline screening rate (3 months prior to intervention) to 9-12 months after start of intervention ]
    Rate of women 21-29 years who received cervical cytology tests over the total number of women 21-29 years.

  • 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 over the total number of women 21-29 years.


Secondary Outcome Measures:
  • Cervical Cancer Screening Test Interval [ Time Frame: Change from baseline screening interval to 3-15 months after start of intervention ]
    Cervical cytology test interval among women who received their second cervical cytology test from the same provider 3-15 months after the intervention started.

  • Rate of LEEP/Cryotherapy [ Time Frame: Change from baseline LEEP/cryotherapy rate (3 months prior to intervention) to 3-6 months after start of intervention ]
    Rate of women 21-29 years who receive LEEP (loop electrosurgical excision procedure) or cryotherapy to treat cervical dysplasia over the total number of women 21-29 years.

  • Rate of LEEP/Cryotherapy [ Time Frame: Change from baseline LEEP/cryotherapy rate (3 months prior to intervention) to 9-12 months after start of intervention ]
    Rate of women 21-29 years who receive LEEP (loop electrosurgical excision procedure) or cryotherapy to treat cervical dysplasia over the total number of women 21-29 years.

  • Rate of LEEP/Cryotherapy [ Time Frame: Change from baseline LEEP/cryotherapy rate (3 months prior to intervention) to 15-18 months after start of intervention ]
    Rate of women 21-29 years who receive LEEP (loop electrosurgical excision procedure) or cryotherapy to treat cervical dysplasia over the total number of women 21-29 years.

  • Rate of Colposcopy [ Time Frame: Change from baseline colposcopy rate (3 months prior to intervention) to 3-6 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.

  • Rate of Colposcopy [ Time Frame: Change from baseline colposcopy rate (3 months prior to intervention) to 9-12 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.

  • 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.


Estimated Enrollment: 10500
Study Start Date: July 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobile Application (APP)
Mobile phone application for providers.
Device: Mobile Application (APP)
Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
Experimental: Patient-Centered Approach (PCA) + APP
Patient educational tool; plus the Mobile phone application for providers.
Device: Patient-Centered Approach (PCA) + APP

Patient-Centered Approach (PCA): 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.

APP: Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.

No Intervention: Comparison 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.

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) 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 7 clinics chosen at random (those not randomized) using 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 7 sites into each of the two intervention arms 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 (7 sites) resulting in a total of 21 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.

  Eligibility

Ages Eligible for Study:   21 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02270021

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Latinas Contra Cancer
National Cervical Cancer Coalition
California Department of Health Services
American College of Obstetricians and Gynecologists
American Society for Colposcopy and Cervical Pathology
Quest Diagnostics
Investigators
Principal Investigator: Anna-Barbara Moscicki, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02270021     History of Changes
Other Study ID Numbers: 13-12257  CD-1304-6551 
Study First Received: October 14, 2014
Last Updated: December 1, 2015

Keywords provided by University of California, San Francisco:
Pap smear
Screening
Women
Human papillomavirus
Cervical precancer
Guideline adherence

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions

ClinicalTrials.gov processed this record on February 17, 2017