Abstract OT3-15-01: Pilot of lifestyle InterventiON to reducE brEast cancer Risk (PIONEER): A randomised study
Authors: Law Rebekah SL , Pitches Carol , Krupa Katherine , Brentnall Adam , Rusby Jennifer 
Published: March 2020

Abstract
Background: Breast cancer causes more deaths than any other medical condition in women aged 30-50 years in the UK. Around 23% of breast cancers are preventable, yet many women are unaware of the modifiable risk factors. Risk factors for breast cancer can be broadly divided into fixed: family history of breast cancer and genetic factors, mammographic breast density, benign proliferative breast disease, hormonal and reproductive risk factors, and modifiable lifestyle factors such as increased weight, decreased physical activity and alcohol consumption. The latter are the focus of this study.
Trial Design
In this feasibility study women who have attended a symptomatic clinic and do not have cancer will be randomised into three intervention arms (see below) with a further 2-way randomisation to single-nucleotide polymorphism (SNP) testing (or not). All women will be told their estimated breast cancer risk as calculated by the Tyrer-Cuzick model. Women will be asked to set goals related to behaviour change. The primary end point is whether these goals have been met. Goal setting, information and changes are mapped to the Behaviour Change Wheel model.
Eligibility criteria FemaleAge 30 - 60 yearsAttending the symptomatic breast clinic at our facilityBenign or normal diagnosisAgree to receive their personalised breast cancer riskAvailable to participate in a 1 year risk reduction programme
NOTE: after risk assessment, women with a less than population risk of breast cancer will be excluded from participating in the behavioural change elements.
Specific aims
To assess which of the interventions is most suitable to take forward into a large-scale study based on acceptability, impact on behaviour and scalability. This will give useful guidance to the future development of a national study with the aim of a meaningful reduction in breast cancer risk.
Trial arms Standard breast cancer risk information book (control)Website with information and bespoke goal-setting exerciseWebsite as above + group coaching
Standard breast cancer risk information book (control)
Website with information and bespoke goal-setting exercise
Website as above + group coaching
2-way randomisation to SNP testing or not for each arm, hence 6 possibilities
Statistical methods
Population: 240 participants who were randomised and did not withdraw following their randomisation allocation (per-protocol analysis). The reason is in this feasibility study we are most interested in the effect of different interventions on those who actually participate in the study. Secondary analyses will include an intention-to-treat basis using everyone randomised. Exploratory analyses to adjust for non-compliance will also be undertaken.
Comparisons The main comparisons of interest are between the control and intervention arms, in particular the proportion achieving their goal. Mean change in weight, alcohol intake and physical activity will also be assessed. Further comparisons will be by SNP testing group.
Secondary comparisons are as follows: Acceptability of study - proportion of women approached who consentAcceptability of randomisation - proportion of women who withdraw after randomisationImpact of SNP testing - mean change and proportion of women who achieve goal in the SNP testing and no SNP testing groupsEfficacy - mean change in each modifiable risk factor in each of the intervention groupsCancer-related anxiety - mean change in score for cancer anxiety at 12 months by SNP testing and intervention group and correlation between initial score and change in risk-factorsRetention - proportion of women who complete their end of study questionnaire, according to study groupChemoprevention - proportion of women in the high and moderate risk groups taking endocrine therapy at one year according to study groupScalability - estimate of cost per participant
Accrual
None to date. Recruitment of 240 women will start in September 2019.
Contact
Pioneer.study@nhs.net
Citation Format: Rebekah SL Law, Carol Pitches, Katherine Krupa, Adam Brentnall, Jennifer Rusby. Pilot of lifestyle InterventiON to reducE brEast cancer Risk (PIONEER): A randomised study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT3-15-01.