PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Royal Marsden NHS Foundation Trust240 enrolled

Overview

A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions: * Breast cancer risk leaflet only * lifestyle website * lifestyle website plus group coaching. Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score. The primary end point will be whether or not women achieve their lifestyle goal.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

240

Conditions

Breast Cancer Lifestyle Risk Reduction

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * Aged between 30 and 60 years * Attending the symptomatic breast clinic at RMH Sutton or Chelsea OR the family history clinics at RMH Sutton or Chelsea, or has heard about the study through other means such as (but not limited to), friends who have been diagnosed with cancer, friends who are already taking part in the PIONEER study, social media, mainstream media, fliers through the doors of houses in the area of RMH. * Benign or B3 diagnosis if participant has attended clinic * Agree to receive their personalised breast cancer risk * Available to participate in a 1 year risk prevention programme * Able to attend the Royal Marsden for a blood test if randomised to this group Exclusion Criteria: * Malignant Diagnosis * Does not want to find out personalised breast cancer risk * Not available to participate for the full year * NOTE: after risk assessment, women who have a breast cancer risk lower than that of population level will be excluded from participating in the behavioural change elements.

Outcomes

Primary Outcomes

Goal achievement

Whether women have achieved their lifestyle goals. Proportion answering "yes" to a binary question: Did you achieve the goal you set? Compared between the three arms.

Time frame: Women will be asked this 12 months after entering the study

Secondary Outcomes

To assess the acceptability of women to find out their personalised breast cancer risk and to commit to making a change in a modifiable risk factor

Proportion of women approached who go on to join the study

Time frame: Measured when recruitment is complete, estimated at 3 months from start date

To assess the acceptability of randomisation to different arms of intervention

Attrition rate after randomisation within each group

Time frame: Measured when the final participant has completed 12 months in the study, estimated 15 months from start date

To assess the impact of SNP testing on changes in behavioural risk factors

Goal achievement in SNP group compared with goal achievement in non-SNP group.