Randomized Trial to Increase Adherence to Cervical Cancer Screening Guidelines for Young Women

Investigator: Anna-Barbara Moscicki, MD
Sponsor: Patient-Centered Outcomes Research Inst

Location(s): United States


Cervical cancer screening (CCS) with cytology has saved thousands of women’s lives. However, because cytology is not perfect, thousands of women get extra tests they don’t need, including biopsies (taking a piece of tissue out of the cervix) and treatments that result in removing large portions of the cervix. We now know that these treatments in young women are often unnecessary, since the dysplasia will go away all on its own. In addition, these treatments can affect the strength of the cervix that may result in babies being born [prematurely] (sic). Many women also experience emotional stress because of treatments. As a result, recent US guidelines recommend CCS every 3 years instead of every year, and they recommend not treating young women with dysplasia but [rather] (sic) to follow them closely every 6–12 months until it goes away. Studies show this is safe and helps women avoid getting overtreated. 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 three different doctor- and patient-based interventions that will help prevent [unnecessary] (sic) screening and treatments in young women less than 30 years of age. We picked this age since these are the women most likely to want to get pregnant and [who are likely to] (sic) be negatively affected by overscreening. We will select clinics from California that serve underinsured women, [comprising] (sic) the Family PACT provider network [in which] (sic) 40% of the women are Latina. We chose to work in this network since 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 four interventions:

(1) provider-based feedback (PBF) intervention alone;

(2) mobile phone application (APP-based) intervention for providers plus PBF;

(3) patient-centered approach (PCA) intervention plus PBF; and the three arms will be compared to:  

(4) no intervention arm (control). PBF will be written messages on cytology lab reports that will spell out the guidelines. 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 direct input from women from the community who are 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] (sic) laboratories will help us develop the doctor-based interventions. We plan to enroll about 10,000 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]