NCT04574063Active, not recruitingNot Applicable
Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
Royal Marsden NHS Foundation Trust1 site in 1 country240 target enrollmentStarted: September 16, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Goal achievement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Breast cancer risk leaflet only
No Intervention
Breast cancer risk leaflet PLUS SNPs
No Intervention
Lifestyle website only
Experimental
Intervention: Lifestyle intervention to reduce breast cancer risk (Behavioral)
Lifestyle website PLUS SNPs
Experimental
Intervention: Lifestyle intervention to reduce breast cancer risk (Behavioral)
Lifestyle website PLUS group coaching
Experimental
Intervention: Lifestyle intervention to reduce breast cancer risk (Behavioral)
Lifestyle website PLUS group coaching PLUS SNPs
Experimental
Intervention: Lifestyle intervention to reduce breast cancer risk (Behavioral)
Outcomes
Primary Outcomes
Goal achievement
Time Frame: Women will be asked this 12 months after entering the study
Whether women have achieved their lifestyle goals. Proportion answering "yes" to a binary question: Did you achieve the goal you set? Compared between the three arms.
Secondary Outcomes
- To assess the acceptability of randomisation to different arms of intervention(Measured when the final participant has completed 12 months in the study, estimated 15 months from start date)
- To assess the impact of SNP testing on changes in behavioural risk factors(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To assess the impact of the different interventions on changes in behavioural risk factors(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To identify whether there is an association between initial Cancer Worry Scale (Revised) score and change in behavioural risk factors(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- 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(Measured when recruitment is complete, estimated at 3 months from start date)
- To assess the impact of knowledge of breast cancer risk on cancer anxiety scores(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To identify whether commitment to a study of this design is sustainable and affected by study group(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To assess the impact of the different interventions on uptake and adherence to chemoprevention at 1 year(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
- To consider the scalability of each element of the pilot study(Measured when the final participant has completed 12 months in the study estimated 15 months from start date)
Investigators
Study Sites (1)
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