PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Royal Marsden NHS Foundation Trust

Status: Active, not recruiting

Conditions: Breast Cancer; Lifestyle Risk Reduction

Treatments: Behavioral: Lifestyle intervention to reduce breast cancer risk

Study type: Interventional

Funder types: Other

Identifiers

NCT04574063

CCR 5113

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 6 patient groups

Breast cancer risk leaflet only

No Intervention group

Breast cancer risk leaflet PLUS SNPs

No Intervention group

Lifestyle website only

Experimental group

Treatment:

Behavioral: Lifestyle intervention to reduce breast cancer risk

Lifestyle website PLUS SNPs

Experimental group

Treatment:

Behavioral: Lifestyle intervention to reduce breast cancer risk

Lifestyle website PLUS group coaching

Experimental group

Treatment:

Behavioral: Lifestyle intervention to reduce breast cancer risk

Lifestyle website PLUS group coaching PLUS SNPs

Experimental group

Treatment:

Behavioral: Lifestyle intervention to reduce breast cancer risk