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Trial record 2 of 136 for:    cervical cancer University of California

Decreasing Over Screening and Treatment of Cervical Precancers in Young Women

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ClinicalTrials.gov Identifier: NCT02270021
Recruitment Status : Active, not recruiting
First Posted : October 21, 2014
Last Update Posted : July 14, 2017
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

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Mobile Application (APP) Device: Patient-Centered Approach (PCA) + APP Not Applicable

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women
Actual Study Start Date : July 24, 2014
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 procedures since intervention start date.

  2. 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 procedures since intervention start date.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02270021     History of Changes
Other Study ID Numbers: 13-12257
CD-1304-6551 ( Other Grant/Funding Number: PCORI )
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

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