Effect of an Information Leaflet on Breast Cancer Screening Participation. A Randomized Controlled Study
Abstract Objective: To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women’s participation.Methods: This randomized controlled study was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50-69 years invited to screening between September 2019 and January 2020. One hospital attended a population with a lower socioeconomic status than the other. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. We compared the participation rate between groups, stratified by hospital and by per-protocol and intention-to-treat analyses. Results: We included 11,119 women in the study: 5,416 in the intervention group and 5,703 in the control group. A total of 36.4% (1,964/5,393) of the women in the intervention group and 37.5% (2,135/5,694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation -1.1%; 95% CI; -2.9% to 0.7%, p-value=0.240). In the hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (-1.4%, 95% CI: -5.7% to -0.03%, p-value=0.029). In the per-protocol analysis, participation was lower in the intervention group (-2.6%, 95% CI: -4.6% to -0.5%, p-value=0.015). Conclusions: Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status.