Health Status of Women With Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy

Conditions
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Women With Early Breast Cancer, Breast Conserving Surgery, Radiotherapy

Intervention / Treatment
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* Other: EQ5D questionnaire and a demographic questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Over 18 year of age Has had breast cancer, treated with both breast conserving surgery and radiotherapy. Is willing to complete an EQ5D and a demographic questionnaire. Exclusion Criteria: Does not speak sufficiently to complete a study questionnaires. Has not already been approached to complete an OSTaRa questionnaire.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Disease free<br>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. | Other: EQ5D questionnaire and a demographic questionnaire<br>* questionnaires<br>|
| Local recurrences<br>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. | Other: EQ5D questionnaire and a demographic questionnaire<br>* questionnaires<br>|
| Distant disease<br>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. | Other: EQ5D questionnaire and a demographic questionnaire<br>* questionnaires<br>|
| Mastectomy<br>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. | Other: EQ5D questionnaire and a demographic questionnaire<br>* questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |