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The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost utility analysis, QALY data is required. This can either be collected within trial or published data can be used.
In the United Kingdom (UK) there is no up to date QALY data for women with early breast cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to date QALY data for women in this cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disease free | Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires are disease free. |
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| Local recurrences | Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with local recurrence and may be undergoing treatment for this. |
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| Distant disease | Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have been diagnosed with distant disease and may be undergoing treatment for this. |
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| Mastectomy | Women who have been treated for early breast cancer with breast conserving surgery and radiotherapy and at the time of completing study questionnaires have undergone a mastectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EQ5D questionnaire and a demographic questionnaire | Other | questionnaires |
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| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire | Each subject will complete an EQ5D questionnaire, to allow Quality of Life to be calculated. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none, slight, moderate, severe or unable to perform. Levels are coded 1-5 and a total score is then generated. Results for the demographic measured will be displayed as a percentage value. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who satisfy the inclusion exclusion criteria can be selected either from clinic notes, MDT records, or at clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chris Brew-Graves, MSc | Contact | 02076799280 | c.brew-graves@ucl.ac.uk | |
| SITU | Contact | situ.ostara@ucl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Western Hospitals NHS Foundation Trust | Recruiting | Swindon | Wiltshire | SN3 6BB | United Kingdom |
The OSTaRa study team will adhere to SITU's data sharing policy.
Once the study has been published
Apply to SITU requesting the study data set. Send your request to situ.trial@ucl.ac.uk
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