Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women (UCSF sub-in)

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Investigator: Heike Thiel De Bocanegra, MPH, PhD
Sponsor: University of California Los Angeles (UCLA)

Location(s): United States

Description

Cervical cancer screening (CCS) with cytology has saved the lives of thousands of women. However, because cytology is not perfect, thousands of women get extra tests they don’t need, including biopsies and treatments that result in removing large portions of the cervix. We now know that these treatments in young women are often unnecessary, because dysplasia will go away on its own. In addition, these treatments can diminish the strength of the cervix, which may result in babies being born prematurely. Many women also experience emotional stress because of treatments. As a result, recent national guidelines recommend CCS every three years instead of every year, and not treating young women with dysplasia but instead monitoring them closely every six to 12 months until it subsides. Studies show this is safe and it helps women avoid overtreatment. Unfortunately, many doctors do not follow the guidelines. This might be because they are unaware of the guidelines, or that women insist on screening and treatments. This study will examine two different doctor- and patient-based interventions that will help prevent unnecessary screening and treatments in young women less than 30 years of age. We picked this age because these are the women most likely to want to get pregnant and who are likely to be negatively affected by overscreening.

We will select clinics from Southern California that serve underinsured women, including the Family PACT provider network, in which 40 percent of the women are Latina. We chose to work in this network so that we can follow how many women get cytology, and get treatments based on how they bill. We will randomly assign these clinics to one of three interventions: (1) mobile phone application (APP-based) intervention for providers alone; (2) patient-centered approach (PCA) intervention plus APP-based intervention for providers; and the two arms will be compared to: (3) no intervention arm (control). The APP will guide providers through the guidelines. The PCA will be focused on educating women and helping them understand the guidelines, as well as the choices for treatment. The intervention will occur before they see the doctor, to help them ask questions of the doctor and to assist them with treatment choices.

Interventions will be developed with input from members of the National Cervical Cancer Coalition and the Latina Contra Cancer group. Organizations including the American Congress of Obstetricians and Gynecologists, the State Office of Family Planning, the American Society for Colposcopy and Cervical Pathology, and Quest Diagnostics laboratories will help us develop the doctor-based interventions. We plan to enroll anywhere from 8,400 to 10,500 women. We will examine the average interval between cytology specimens, and the number of dysplasia treatments before and after the interventions to see if the interventions were effective.