Decreasing Over Screening and Treatment of Cervical Precancers in Young Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 21 - 29 |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | June 2017 |
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.
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.
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.
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.
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
We found this trial at
2
sites
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
Click here to add this to my saved trials
Click here to add this to my saved trials