A randomized trial on breast self-examination in Faenza (northern-Italy)

Aims and background: The aim of this randomized controlled trial was to compare two methods for teaching breast self-examination: theoretical and practical session versus mailed material, Methods: A random sample of women aged 20-64 years was drawn from the demographic file of the city of Faenza (Northern-Italy). Of 825 sampled eligible women, 168 declined participation, 657 were randomly assigned, after completing a pretest questionnaire aimed at evaluating practice and quality of breast self-examination, Individualised instruction was administered to the treatment group invited to be taught breast self-examination in a medical practice setting, The control group received mailed information about breast self-examination, One year later, 443 women completed the posttest questionnaire, Results: As far as concerns the first outcome of the trial (change in practice of breast-self examination) our study showed, after adjusting for lost-to-follow-up, no difference between the treatment and the control group. The analysis performed to evaluate the second outcome (change in quality of breast self-examination practice) showed that women of the treatment group improved the quality of breast self-examination practice more than the control group (Wilcoxon test, z=2.4, P<0.01), The same results have been confirmed by multiple regression analyses taking into account all potential confounders, No selection bias affected these results, Conclusion: Theoretical and practical sessions resulted in an improved quality of examination technique than did mailed material.