Breast Cancer, Lifestyle Risk Reduction
Conditions
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.
Interventions
BEHAVIORALLifestyle 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.
Sponsors
National Institute for Health Research, United Kingdom
Royal Marsden NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goal achievement | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Attrition rate after randomisation within each group |
| 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 | Goal achievement in SNP group compared with goal achievement in non-SNP group. |
| 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 | Goal achievement compared between leaflet only group, website group and website + coaching group. |
| 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 | 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. |
| 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 | Proportion of women approached who go on to join the study |
| 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 | Participant retention rate. |
| 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 | Proportion of women still taking chemoprevention at close of study compared between the three arms. |
| 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 | Administration time required for each group; Average goal achievement compared to average cost of each intervention. |
| 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 | Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety. |
Countries
United Kingdom
Outcome results
None listed