Development and pilot of an online, personalized risk assessment tool for a breast cancer precision medicine trial

Abstract

Breast cancer risk reduction has been validated by large-scale clinical trials, but uptake remains low. A risk communication tool could provide personalized risk-reduction information for high-risk women. A low-literacy-friendly, visual, and personalized tool was designed as part of the Women Informed to Screen Depending On Measures of risk (WISDOM) study. The tool integrates genetic, polygenic, and lifestyle factors, and quantifies the risk-reduction from undertaking medication and lifestyle interventions. The development and design process utilized feedback from clinicians, decision-making scientists, software engineers, and patient advocates. We piloted the tool with 17 study participants, collecting quantitative and qualitative feedback. Overall, participants felt they better understood their personalized breast cancer risk, were motivated to reduce their risk, and considered lifestyle interventions. The tool will be used to evaluate whether risk-based screening leads to more informed decisions and higher uptake of risk-reduction interventions among those most likely to benefit.

Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420)

“…The study was not randomised and was dramatically impacted by the COVID-19 pandemic with uptake of the study and of risk appointments in those identified at moderate or high risk almost certainly affected. As such, generalisability of the results may need to be reassessed after the results from two large randomised trials [ 32 , 33 ] are available. We were unable to use the original counterbalanced design, which would have allowed better estimation of differences between BC-Predict and NHSBSP rates and could not answer the question of whether there were lower rates for screening uptake (although there was no evidence of this in PROCAS-1 [ 10 ]).…”

“…It also addresses a number of research gaps identified in breast cancer risk stratification [ 23 , 34 ]. There are a number of other important initiatives in progress including the WISDOM [ 32 ] and MyPEBS [ 33 ] studies, but both are still open to recruitment and have not yet reported results of risk feedback.…”

BREAst screening Tailored for HEr (BREATHE)—A study protocol on personalised risk-based breast cancer screening programme

“…Personal risk of breast cancer is a difficult concept to grasp. Breast cancer risk prediction tools are mainly designed for providers, hence the participant may have a limited understanding of the results [ 52 ]. We deliberated over the readiness of the Singapore’s population to receive personalised disease risk results with various stakeholders (representatives of the hospitals and clinics, ethics representatives, public health experts, and researchers), and concluded that only the general risk classification (below-average, average and above-average risk) is to be conveyed to the participants as part of this research study.…”

Validation of an Abridged Breast Cancer Risk Prediction Model for the General Population

“…Despite the efficacy of risk-reducing medication, clinician recommendation and patient uptake are both dismal, although both vary greatly depending on the clinical scenario (24). Recently, efforts have been made to improve risk prediction to increase the uptake of prophylactic endocrine therapy in women at increased risk (25)(26)(27).…”