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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer risk leaflet only | No Intervention | ||
| Breast cancer risk leaflet PLUS SNPs | No Intervention | ||
| Lifestyle website only | Experimental |
| |
| Lifestyle website PLUS SNPs | Experimental |
| |
| Lifestyle website PLUS group coaching | Experimental |
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| Lifestyle website PLUS group coaching PLUS SNPs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention to reduce breast cancer risk | Behavioral | Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Rusby | The Royal Marsden Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden Hospital NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37336835 | Derived | Law R, Krupa K, Rusby J. Preventative therapy for breast cancer: a clinical experience. Breast Cancer Res Treat. 2023 Sep;201(2):205-213. doi: 10.1007/s10549-023-06985-1. Epub 2023 Jun 19. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |