Study of the role of breast self-examination in the reduction of mortality from breast cancer. The Russian Federation/World Health Organization Study.

The protocol of a study, sponsored by the World Health Organization, of the role of breast self-examination (BSE) in reduction of mortality from breast cancer is presented. The major objective of the study is to determine the effect of a BSE programme on mortality from breast cancer. A population of of over 193,000 women aged 40 to 64 has been defined in Moscow and St Petersburg and randomised to study and control groups. In Moscow the education programme is based on a two-way communication principle allowing efficient person-to-person education in groups of up to 20 individuals and feedback information through specially designed personal calendars. In St Petersburg, class and individual instruction is carried out. After a 1-year feasibility study the project is planned to last for 15 years. It consists of an aggressive education programme, during and following which, all newly diagnosed breast cancers will be registered and treated, and followed up for 3 to 15 years. A key issue of the study is compliance of the population with BSE. The frequency and competence of BSE practice has been defined in subsamples of 400 randomly selected women by means of surveys at 6 months, 1, 2 and 3 years after the start of the project. The study is expected to result in the accrual of more than 1470 new breast cancer cases and 778 deaths from breast cancer. The power of the study is expected to permit detection of a 30% reduction in cumulative breast cancer mortality, assuming that 50-70% of the women in the study group practise BSE.