Study cohort characteristics and design of the WISDOM trial comparing risk-based versus annual breast cancer screening

The Women Informed to Screen Depending on Measures of risk (WISDOM) Study is a pragmatic randomized controlled trial evaluating risk assessment to inform the age to start, frequency, and modality of breast cancer screening and risk reduction. The design of the study enables women to decline randomization to self-select their screening arm. The risk-based arm included comprehensive breast cancer risk assessment using the Breast Cancer Surveillance Consortium model and genetics. From August 2016 to February 2023, WISDOM enrolled a large, diverse nationwide cohort of 46,403 participants. Mean age at baseling was 54 years, A total of 28,372 women (61%) were randomized, while 89% of those who self-selected their screening arm chose risk-based screening. The authors conclude that this design captured real-world screening preference while maintaing scientific rigor and demonstrated strong participant preference for risk-based screening.