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PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk | Clinical Trials | Clareo Health

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PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)

NCT04574063•Royal Marsden NHS Foundation Trust

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.

Eligibility

Age

30 - 60 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

The Royal Marsden Hospital NHS Foundation Trust

Sutton, United Kingdom

Key Dates

Start Date

September 16, 2020

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

January 18, 2023

Enrollment

240

ESTIMATED participants

Conditions

Breast CancerLifestyle Risk Reduction

Interventions

Lifestyle intervention to reduce breast cancer risk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer