PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Study Overview
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Brief Summary
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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.

Official Title
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Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)

Conditions
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Breast Cancer, Lifestyle Risk Reduction

Intervention / Treatment
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* Behavioral: Lifestyle intervention to reduce breast cancer risk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breast cancer risk leaflet only<br> | |
| No Intervention: Breast cancer risk leaflet PLUS SNPs<br> | |
| Experimental: Lifestyle website only<br> | Behavioral: Lifestyle intervention to reduce breast cancer risk<br>* Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.<br>|
| Experimental: Lifestyle website PLUS SNPs<br> | Behavioral: Lifestyle intervention to reduce breast cancer risk<br>* Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.<br>|
| Experimental: Lifestyle website PLUS group coaching<br> | Behavioral: Lifestyle intervention to reduce breast cancer risk<br>* Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.<br>|
| Experimental: Lifestyle website PLUS group coaching PLUS SNPs<br> | Behavioral: Lifestyle intervention to reduce breast cancer risk<br>* Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goal achievement | 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. | Women will be asked this 12 months after entering the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Proportion of women approached who go on to join the study | Measured when recruitment is complete, estimated at 3 months from start date | 
| To assess the acceptability of randomisation to different arms of intervention | Attrition rate after randomisation within each group | 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 | Goal achievement in SNP group compared with goal achievement in non-SNP 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 changes in behavioural risk factors | Goal achievement compared between leaflet only group, website group and website + coaching group. | Measured when the final participant has completed 12 months in the study estimated 15 months from start date | 
| To assess the impact of knowledge of breast cancer risk on cancer anxiety scores | Change in Cancer Worry Scale (Revised) score from 0 to 3 months. Cancer Worry score is measured between 8 and 32 with 32 being the highest level of anxiety. | 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 | Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety. | 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 | Participant retention rate. | 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 | Proportion of women still taking chemoprevention at close of study compared between the three arms. | 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 | Administration time required for each group; Average goal achievement compared to average cost of each intervention. | Measured when the final participant has completed 12 months in the study estimated 15 months from start date |