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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- The DCCPS Team.