A Randomized Trial on Breast Self-Examination in Faenza (Northern-Italy)

Abstract

The aim of this randomized controlled trial was to compare two methods for teaching breast self-examination: theoretical and practical session versus mailed material. 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. 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. Theoretical and practical sessions resulted in an improved quality of examination technique than did mailed material.