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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
2R01CA074801-04
Application #
6207599
Study Section
Special Emphasis Panel (ZRG1-SNEM-1 (01))
Program Officer
Woolley, Sabra
Project Start
1997-09-30
Project End
2003-08-31
Budget Start
2000-09-01
Budget End
2001-08-31
Support Year
4
Fiscal Year
2000
Total Cost
$187,402
Indirect Cost
Name
Tata Memorial Hospital
Department
Type
DUNS #
City
Mumbai
State
Country
India
Zip Code
40001-2
Shastri, Surendra S; Mittra, Indraneel; Mishra, Gauravi A et al. (2014) Effect of VIA screening by primary health workers: randomized controlled study in Mumbai, India. J Natl Cancer Inst 106:dju009