Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol.

INTRODUCTION: Breast cancer incidence starts to increase exponentially when women reach 30-39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this age group could lead to those at higher risk receiving benefits of earlier screening and preventive strategies. Currently, risk assessment is limited to women with a family history of breast cancer only. The Breast CANcer Risk Assessment in Younger women (BCAN-RAY) study is evaluating a comprehensive breast cancer risk assessment strategy for women aged 30-39 years incorporating a questionnaire of breast cancer risk factors, low-dose mammography to assess breast density and polygenic risk. This study will assess the feasibility and acceptability of the BCAN-RAY risk assessment strategy. METHODS AND ANALYSIS: This study involves women undergoing risk assessment as part of the BCAN-RAY case-control study (n=750). They will be aged 30-39 years without a strong family history of breast cancer and invited to participate via general practice. A comparison of uptake rates by socioeconomic status and ethnicity between women who participated in the BCAN-RAY study and women who declined participation will be conducted. All participants will be asked to complete self-report questionnaires to assess key potential harms including increased state anxiety (State Trait Anxiety Inventory), cancer worry (Lerman Cancer Worry Scale) and satisfaction with the decision to participate (Decision Regret Scale), alongside potential benefits such as feeling more informed about breast cancer risk. A subsample of approximately 24 women (12 at average risk and 12 at increased risk) will additionally participate in semistructured interviews to understand the acceptability of the risk assessment strategy and identify any changes needed to it to increase uptake. ETHICS AND DISSEMINATION: Ethical approval was granted by North West-Greater Manchester West Research Ethics Committee (reference: 22/NW/0268). Study results will be disseminated through peer-reviewed journals, conference presentations and charitable organisations. TRIAL REGISTRATION NUMBER: NCT05305963.

Optimising the delivery of breast cancer risk assessment for women aged 30-39 years: A qualitative study of women's views.

BACKGROUND: Identifying women aged 30-39 years at increased risk of developing breast cancer could allow them to consider screening and preventive strategies. Research is underway to determine the feasibility of offering breast cancer risk assessment to this age group. However, it is unclear how best to deliver and communicate risk estimates to these women, in order to avoid potential harms such as undue anxiety and increase benefits such as informed decision-making. OBJECTIVES: This study aimed to investigate women's views on, and requirements for, this proposed novel approach to risk assessment. DESIGN: A cross-sectional qualitative design was used. METHODS: Thirty-seven women aged 30-39 years with no family history or personal history of breast cancer participated in seven focus groups (n = 29) and eight individual interviews. Data were analysed thematically using a framework approach. RESULTS: Four themes were developed. Acceptability of risk assessment service concerns the positive views women have towards the prospect of participating in breast cancer risk assessment. Promoting engagement with the service describes the difficulties women in this age group experience in relation to healthcare access, including mental load and a lack of cultural awareness, and the implications of this for service design and delivery. Impact of receiving risk results focuses on the anticipated impacts of receiving different risk outcomes, namely, complacency towards breast awareness behaviours following low-risk results, an absence of reassurance following average-risk results and anxiety for high-risk results. Women's information requirements highlights women's desire to be fully informed at invite including understanding why the service is needed. In addition, women wanted risk feedback to focus on plans for management. CONCLUSION: The idea of breast cancer risk assessment was received favourably among this age group, providing that a risk management plan and support from healthcare professionals is available. Determinants of acceptability of a new service included minimising effort required to engage with service, co-development of invitation and risk feedback materials and the importance of educational campaigning about the potential benefits of participation in risk assessment.

Proactive breast cancer risk assessment in primary care: a review based on the principles of screening.

In the UK, the National Institute for Health and Care Excellence (NICE) recommends that women at moderate or high risk of breast cancer be offered risk-reducing medication and enhanced breast screening/surveillance. In June 2022, NICE withdrew a statement recommending assessment of risk in primary care only when women present with concerns. This shift to the proactive assessment of risk substantially changes the role of primary care, in effect paving the way for a primary care-based screening programme to identify those at moderate or high risk of breast cancer. In this article, we review the literature surrounding proactive breast cancer risk assessment within primary care against the consolidated framework for screening. We find that risk assessment for women under 50 years currently satisfies many of the standard principles for screening. Most notably, there are large numbers of women at moderate or high risk currently unidentified, risk models exist that can identify those women with reasonable accuracy, and management options offer the opportunity to reduce breast cancer incidence and mortality in that group. However, there remain a number of uncertainties and research gaps, particularly around the programme/system requirements, that need to be addressed before these benefits can be realised.