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PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

NCT04574063 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-01-18

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Lifestyle intervention to reduce breast cancer risk

Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Jennifer Rusby · The Royal Marsden Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04574063 on ClinicalTrials.gov