Abstract

Objective To investigate the effect of notifying women of their dense breasts on their psychosocial outcomes and health service use intentions.

Design Multisite parallel arm randomised controlled trial.

Setting Population based breast screening programme in Queensland, Australia.

Participants Women aged ≥40 years having screening and classified as having mammographically dense breasts (BI-RADS C-D from automated density measure).

Intervention Women were randomised equally to standard care (no notification of breast density), notification of breast density plus written health literacy sensitive information (intervention 1), or notification of density plus a link to online video based health literacy sensitive information (intervention 2).

Main outcome measures Psychological (feeling anxious, confused, or informed) and health service use intentions (general practitioner consultation related to breast density, supplemental screening) at 8 weeks post-screening.

Results Between September 2023 and July 2024, 3107 women (1030 control, 1003 intervention 1, and 1074 intervention 2) were randomised, and 2401 women (802 control, 776 intervention 1, and 823 intervention 2) with a mean age at baseline of 57.4 (standard deviation 9.9) years were included in the analysis. Compared with the control group, women who were notified of their dense breasts reported feeling significantly more anxious (intervention 1: odds ratio 1.30, 95% confidence interval (CI) 1.08 to 1.57; intervention 2: odds ratio 1.28, 1.07 to 1.54) and confused (intervention 1: odds ratio 1.92, 1.58 to 2.33; intervention 2: odds ratio 1.76, 1.46 to 2.13) and had significantly higher intentions to talk to their general practitioner about their screening results (intervention1: relative risk ratio 2.08, 95% CI 1.59 to 2.73; intervention 2: relative risk ratio 1.71, 1.31 to 2.25) and to rely on their general practitioner for supplemental screening advice (intervention 1: relative risk ratio 2.61, 1.80 to 3.79; intervention 2: relative risk ratio 2.29, 1.58 to 3.33). However, most women did not intend to have supplemental screening (control: 91.3%; intervention 1: 78.9%; intervention 2: 81.4%). Notified women did not feel more informed (intervention 1: odds ratio 0.83, 0.68 to 1.01; intervention 2: odds ratio 0.80, 0.66 to 0.97).

Conclusions Women notified of their dense breasts felt anxious and confused, did not feel more informed to make decisions about their breast health, and wanted to be guided by their general practitioners. Notification of breast density as part of population based breast screening may have adverse outcomes including additional consultation burden on general practitioners to advise women.

Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12623000001695).