Decreasing Over Screening and Treatment of Cervical Precancers in Young Women
Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women
2 other identifiers
interventional
42
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2014
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedSeptember 25, 2019
September 1, 2019
3.8 years
October 14, 2014
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Cervical Cancer Screening
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 Outcomes (1)
Rate of Colposcopy
Change from baseline colposcopy rate (3 months prior to intervention) to 15-18 months after start of intervention
Study Arms (4)
Provider Mobile Application (ProvAPP)
EXPERIMENTALMobile phone application for providers.
ProvAPP + Patient Educational Tool (Tab)
EXPERIMENTALPatient educational tool; plus the Mobile phone application for providers.
ProvAPP Control Group
NO INTERVENTIONClinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data.
ProvAPP+Tab Control Group
NO INTERVENTIONClinics in this group are those NOT randomized - receiving no intervention. These clinics will be chosen at random for comparison using Family PACT claims data.
Interventions
Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- Language other than English or Spanish
- Male
- Younger than 21 or older than 29
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Patient-Centered Outcomes Research Institutecollaborator
- Latinas Contra Cancercollaborator
- National Cervical Cancer Coalitioncollaborator
- California Department of Health Servicescollaborator
- American College of Obstetricians and Gynecologistscollaborator
- American Society for Colposcopy and Cervical Pathologycollaborator
Study Sites (2)
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (1)
Moscicki AB, Chang C, Vangala S, Zhou X, Elashoff DA, Dehlendorf C, Sawaya GF, Kuppermann M, Duron Y, Wyand FL, Navarro SK, Thiel de Bocanegra H. Effect of 2 Interventions on Cervical Cancer Screening Guideline Adherence. Am J Prev Med. 2021 May;60(5):666-673. doi: 10.1016/j.amepre.2020.11.015. Epub 2021 Feb 23.
PMID: 33632649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna-Barbara Moscicki, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 21, 2014
Study Start
July 24, 2014
Primary Completion
April 30, 2018
Study Completion
August 30, 2019
Last Updated
September 25, 2019
Record last verified: 2019-09