Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the “My Personal Breast Screening” (MyPeBS) randomised clinical trial

Abstract

Background The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women’s reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. Methods At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants’ acceptability and comprehension of the trial, and their experience of risk assessment. Discussion Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. Trial registration Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). Clinicaltrials.gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

Healthcare professionals’ views following implementation of risk stratification into a national breast cancer screening programme

“…A study exploring views of low-risk women found this approach overall to be acceptable if extending intervals ensured informed choice, is grounded in evidence-based, and is carefully communicated[ 36 ]. Other qualitative studies are also underway exploring low-risk women’s views[ 37 ].…”

Validation of a decision-analytic model for the cost-effectiveness analysis of a risk-stratified National Breast Screening Programme in the United Kingdom

“…A further necessary requirement has been the development of criteria to categorise woman into specified risk-groups such as low, population risk or high-risk of developing breast cancer in a specified time period (ten-year or life-time). Collectively, the ability to identify a women's risk of breast cancer, approaches to the feedback of individual risk and actions to suggest given the defined risk-category has stimulated interest and the generation of evidence to support the introduction or risk-NBSP (5)(6)(7)(8)(9)(10). To date, there are no examples of a risk-NBSP used in practice but there is consensus about the need for different types of evidence to support their introduction (11).…”

Development and testing of a polygenic risk score for breast cancer aggressiveness

“…Over 200 single nucleotide polymorphisms (SNPs) associated with breast cancer risk have been identified . Ongoing prospective trials are testing the ability of the PRS to inform decision-making around breast cancer screening and prevention [5][6][7] .…”