Breast and cervical cancers account for nearly 50 percent of all deaths from cancer in women in India. The objective of this study is to undertake a community based randomized controlled trial to investigate whether low-cost technology approaches, such as physical examination of the breast (and teaching of breast self examination) and visual inspection of the cervix, conducted by trained female health workers, would be effective in down-staging these cancers at diagnosis and eventually lead to a reduction in mortality. It is proposed to randomize 70,000 women into two groups: one group receiving annual examinations for early detection of breast and cervical cancer and the other acting as a control. The women in the study will be drawn largely from the socioeconomically disadvantaged population in the city of Bombay. The examinations will be given annually for five years and the women will be followed-up for a further period of five years. The sort-term objective of the study would be to demonstrate significant down-staging of breast and cervix cancer at diagnosis at the end of the intervention period (5 years). The longer term objective of the study would be to demonstrate significant reduction in combined mortality from breast and cervix cancer at 10 years. A feasibility study comprising of 3000 women has already been completed, and the methodology of the randomized trial would be based on the lessons learned from the feasibility study. This is one of the first trials of this kind to be conducted in a developing country and its findings may be relevant to other countries and populations with limited financial resources.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA074801-02
Application #
2769948
Study Section
Special Emphasis Panel (ZRG2-SSP (01))
Program Officer
Meissner, Helen I
Project Start
1997-09-30
Project End
2000-08-31
Budget Start
1998-09-18
Budget End
1999-08-31
Support Year
2
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Tata Memorial Hospital
Department
Type
DUNS #
City
Bombay
State
Country
India
Zip Code
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