PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk
PIONEER
Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
1 other identifier
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2020
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJanuary 18, 2023
January 1, 2023
3.2 years
September 7, 2020
January 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Women will be asked this 12 months after entering the study
Secondary Outcomes (9)
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
Measured when recruitment is complete, estimated at 3 months from start date
To assess the acceptability of randomisation to different arms of intervention
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
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of the different interventions on changes in behavioural risk factors
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of knowledge of breast cancer risk on cancer anxiety scores
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
- +4 more secondary outcomes
Study Arms (6)
Breast cancer risk leaflet only
NO INTERVENTIONBreast cancer risk leaflet PLUS SNPs
NO INTERVENTIONLifestyle website only
EXPERIMENTALLifestyle website PLUS SNPs
EXPERIMENTALLifestyle website PLUS group coaching
EXPERIMENTALLifestyle website PLUS group coaching PLUS SNPs
EXPERIMENTALInterventions
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Royal Marsden Hospital NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Law R, Krupa K, Rusby J. Preventative therapy for breast cancer: a clinical experience. Breast Cancer Res Treat. 2023 Sep;201(2):205-213. doi: 10.1007/s10549-023-06985-1. Epub 2023 Jun 19.
PMID: 37336835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Rusby
The Royal Marsden Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2020
First Posted
October 5, 2020
Study Start
September 16, 2020
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share