Clinical trial NCT04574063: PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk
Official title: Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lifestyle Risk Reduction
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2020-10-05
Enrollment: 240
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: 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.

Primary outcomes:
measure: Goal achievement
timeFrame: Women will be asked this 12 months after entering the study
Secondary outcomes:
measure: To assess the acceptability of women to find out their personalised breast cancer risk and to commit to making a change in a modifiable risk factor
timeFrame: Measured when recruitment is complete, estimated at 3 months from start date
measure: To assess the acceptability of randomisation to different arms of intervention
timeFrame: Measured when the final participant has completed 12 months in the study, estimated 15 months from start date
measure: To assess the impact of SNP testing on changes in behavioural risk factors
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
measure: To assess the impact of the different interventions on changes in behavioural risk factors
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
measure: To assess the impact of knowledge of breast cancer risk on cancer anxiety scores
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
measure: To identify whether there is an association between initial Cancer Worry Scale (Revised) score and change in behavioural risk factors
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
measure: To identify whether commitment to a study of this design is sustainable and affected by study group
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
measure: To assess the impact of the different interventions on uptake and adherence to chemoprevention at 1 year
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
measure: To consider the scalability of each element of the pilot study
timeFrame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Other outcomes:
Locations:
city: London Borough of Sutton
country: United Kingdom
facility: The Royal Marsden Hospital NHS Foundation Trust
Study officials:
affiliation: The Royal Marsden Hospital
name: Jennifer Rusby
role: PRINCIPAL_INVESTIGATOR
References: