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Randomized trial to increase adherence to cervical cancer screening guidelines for young women
Investigator (PI): Moscicki, Anna Barbara
Performing Organization (PO): (Current): University of California, Los Angeles, UCLA Health, Mattel Children's Hospital, UCLA Children's Discovery and Innovation Institute / (310) 794-4336
(Past): University of California, San Francisco, School of Medicine, Department of Pediatrics / (415) 476-9181
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/CD-1304-6551
Funding: Total Award Amount: $1,600,980
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: 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. 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 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 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 be negatively affected by overscreening. We will select clinics from California that serve underinsured women, comprising the Family PACT provider network in which 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 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.
Abstract Archived: 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 too early. 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 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 don't 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 too much screening and too many 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 be negatively affected by overscreening. We will select clinics from California that serve underinsured women, called the Family PACT provider network--40% of these 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 1 of 4 interventions: 1) provider-based feedback (PBF) intervention alone, 2) mobile phone application (APP)-based intervention for providers plus PBF, and 3) patient-centered approach (PCA) intervention plus PBF. 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 choices for treatment. The intervention will occur before they see the doctor to help them ask questions of the doctor and help assist them in 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 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 worked.

MeSH Terms:
  • Adult
  • California
  • Cell Phone
  • Early Detection of Cancer /*methods
  • Female
  • * Guideline Adherence
  • Guidelines as Topic
  • Hispanic Americans
  • Humans
  • Medically Uninsured
  • Patient-Centered Care
  • Randomized Controlled Trials as Topic
  • Uterine Cervical Dysplasia /*diagnosis
  • /ethnology
  • Uterine Cervical Neoplasms /*diagnosis
  • /ethnology
  • Young Adult
Country: United States || United States
State: California || California
Zip Code: 90095 / 94143
UI: 20143439
CTgovId: NCT02270021
Project Status: Completed
Record History: ('2018: Project extended to 2019. 2017: Project extended to 2019. Changed PO and PI email address.',) (' Replaced abstract, 8/6/2015',)