Grant Number:	5R01CA076502-03 Interpret this number
Primary Investigator:	Manetta, Alberto
Organization:	University Of California Irvine
Project Title:	Single Visit Cervical Cancer Prevention Program
Fiscal Year:	2000

DESCRIPTION (Applicant's Description) The barriers to cervix cancer screening and management are well described. A significant barrier to the diagnosis and management of cervical cancer is the loss to follow-up for those who undergo screening using the Pap smear. In addition, other barriers include lack of education, cultural-based attitudes and health behaviors, as well as, socioeconomic factors. We believe that the usual approach to cervix cancer screening diagnosis and management accentuates problems due to loss to follow-up and these barriers. The goal of this project is to implement and evaluate an innovative cancer control program that could revolutionize the approach to cervix cancer prevention. The study will determine the effectiveness of a single-visit program (SVP), including the diagnosis and treatment of patients with premalignant conditions, in decreasing the rate of loss to follow-up of women with abnormal Pap smears in comparison to a Usual Care Program (UCP). If successful, the proposed program will markedly decrease the proportion of women who have positive Pap smears and are lost to follow-up and thereby decrease the rates of invasive cervix cancer. Moreover, the program could be transported to communities in the United States and to other countries around the world where the incidence and mortality rates of this malignancy are increased. We have previously demonstrated the feasibility of a single-visit approach in a pilot study completed by our group that indicates that our approach is promising for the secondary prevention and control of cervix cancer The single-visit program (SVP) consists of an initial screening of patients with pelvic exams and Pap smears with immediate cytological analysis by a cytopathologist. All patients receive the results of their Pap smears during the visit. In addition, patients found to have severe cervix dysplasia undergo diathermy loop excision (DLE) of the transformation zone during the same visit. By combining immediate cytologic screening and DLE in the same visit, most barriers to follow-up for patients with cervix dysplasia can be overcome. The specific aims of this proposal are: 1) implement and evaluate a single-visit program for cervix cancer prevention in clinics serving a multi-ethnic population of women; 1a) standardize the operating procedures regarding recruitment plans, personnel, patient flow patterns, and follow-up plans; 1b) set up an efficient system for Pap smear interpretation for patients in the SVP that will minimize waiting time; and, c) recruit 3,520 women (Hispanic and Non-Hispanic White women) and randomize them into the SVP or a usual care program (UCP); and, 2) evaluate the SVP in terms of follow-up rates for abnormal Pap smears, patient satisfaction, and cost-effectiveness.




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