PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk
NCT ID: NCT04574063
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2020-09-16
2023-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Breast cancer risk leaflet only
No interventions assigned to this group
Breast cancer risk leaflet PLUS SNPs
No interventions assigned to this group
Lifestyle website only
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.
Lifestyle website PLUS SNPs
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.
Lifestyle website PLUS group coaching
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.
Lifestyle website PLUS group coaching PLUS SNPs
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
60 Years
FEMALE
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Jennifer Rusby
Role: PRINCIPAL_INVESTIGATOR
The Royal Marsden Hospital
Locations
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The Royal Marsden Hospital NHS Foundation Trust
Sutton, , United Kingdom
Countries
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References
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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.
Other Identifiers
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CCR 5113
Identifier Type: -
Identifier Source: org_study_id
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