An Observational Study Assessing the Health Status in Women With Early Breast Cancer, Treated With Breast Conserving Surgery and Radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Does not speak sufficiently to complete a study questionnaires.
- •Has not already been approached to complete an OSTaRa questionnaire.
结局指标
主要结局
Questionnaire
时间窗: 12 months
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.
次要结局
未报告次要终点