Cervical Intraepithelial Neoplasia
Conditions
Brief summary
1. Implement a single-visit program (SVP) for cervix cancer prevention in clinics serving a multi-ethnic population of women; 2. Set up an efficient system for interpretation of Pap smears for patients in the SVP that will minimize waiting time; 3. Determine the follow-up rates and compare them between women assigned to the SVP and a usual care program (UCP); 4. Determine satisfaction and compare it between women assigned to the SVP and the UCP; 5. Determine the cost-effectiveness and compare it between the SVP and UCP
Detailed description
Women were recruited from underserved communities to participate in this single visit cervix cancer project. Large loop electrosurgical excision procedure (LEEP) was performed on SVP subjects with either a diagnosis of HGSIL/AGUS or suspicion of carcinoma. All other subjects with abnormal Papanicolaou smears were referred to our abnormal cytology clinics or received care in the community.
Interventions
PROCEDURELarge loop electrosurgical excision
Sponsors
National Cancer Institute (NCI)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Older than 18 years * No history of invasive cervical cancer * Not pregnant
Exclusion criteria
* Absence of a cervix * Abnormal vaginal bleeding * Cervical cancer screening within the previous 12 months * A known bleeding disorder * Reluctance to be randomized * Unwillingness to follow the study protocol
Countries
United States
Outcome results
None listed