DESCRIPTION: (Adapted from applicant's abstract): The study is a continuation
of a randomized trial initiated under the NIH Project NO.ROI CA74801-01. Cancer
of the breast and cervix account for almost 4O percent of cancer deaths in
Indian women. The objective is to investigate whether low-cost technology
approaches-- i.e. physical examination of the breast plus teaching of BSE and
visual inspection of the cervix painted with 2 percent acetic acid, to be done
by trained female health workers--will be effective in down-staging the disease
and eventually lead to reduction in mortality. The initial grant of 3 years
ends in October 2000. A fresh application is now made for the next 3 years of
the study. 100,000 socioeconomically disadvantaged women between the ages of
35-64 years are being randomized to 2 arms--one to receive intervention every
18 months for 6 years and the other to act as control. The first of 4 cycles of
18 months began in May 1998 after 5-months training of the field staff and will
end in November 1999, to recruit half the cohort; the other half will be
recruited in the second cycle. Baseline survey of 177,449 women registered on
the election rolls of 10 localities was undertaken to match names/addresses
with those in the rolls. Each locality is subdivided into 2 sections. All women
of one section, which were selected randomly, are eligible to receive
intervention, and none from the other. Up to October 31, 1999, 21,542 women
have been recruited in the intervention arm and 19,228 in the control arm, from
5 localities. The target of 25,000 women per arm is expected to be reached in
the remaining month. Overall 68 percent of the women in the intervention area
and 79 percent of the women from the control area responded to the invitation
to participate in the study. To date 73 percent of the women referred for
further investigations have complied and this proportion is likely to improve
since sufficient time has not elapsed for those referred recently. After the
completion of 4 rounds of screening, the women will be followed-up for 5 more
years, with skeleton staff, to assess mortality due to breast and cervical
cancer. The findings of this trial--one of the first of its kind in a
developing country--may be relevant for other countries with limited financial
resources.
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- The DCCPS Team.
