NCT02293642已完成不适用
Prospective Epidemiology Study to Validate the BOMET-QoL-10 in Patients With Bone Metastasis in Germany
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- QoL
研究概览
简要总结
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
详细描述
Aim of this study is to translate the questionnaire and to examine the psychometric properties of BOMET-QoL-10 in a German population. Correlations with the EORTC QLQ-C30/BM22 at the time of enrolment and throughout the study aim to verify that the BOMET-QoL-10 is reliable, valid and able to detect stabilization or changes in quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults patients (≥ 18 years)
- •Diagnosed cancer of the breast, kidney, lung or prostate
- •Bone metastases
- •Estimated life expectancy of at least 6 months
- •Fluent German speaking, reading and writing
- •Informed written consent
排除标准
- •Patients without bone metastases
- •Participation in another study involving questionnaires
- •Patients not able to comply with the assessments specified in the protocol
结局指标
主要结局
QoL
时间窗: 6 months
Validity and responsiveness of the BOMET-QoL-10 questionnaire in reference to EORTC QLQ-C30/BM-22
次要结局
- Impact of characteristics on questionnaire scores(6 months)
- Sensitivity of questionnaire(6 months)
- Sequence effects of questionnaires(6 months)
研究者
研究点 (1)
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