Clinical trial · Interventional
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk
Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lifestyle Risk Reduction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle intervention to reduce breast cancer risk | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- NO_INTERVENTION
- label
- Breast cancer risk leaflet only
- type
- NO_INTERVENTION
- label
- Breast cancer risk leaflet PLUS SNPs
- type
- EXPERIMENTAL
- label
- Lifestyle website only
- interventionNames
- Behavioral: Lifestyle intervention to reduce breast cancer risk
- type
- EXPERIMENTAL
- label
- Lifestyle website PLUS SNPs
- interventionNames
- Behavioral: Lifestyle intervention to reduce breast cancer risk
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLaw 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 37336835