Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie
研究概览
简要总结
To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.
详细描述
This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice.
The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous)
- •Patients treated with injectable bone antiresorptive therapy for 12 months or more
- •Signed written informed consent
排除标准
- •patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries
- •patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women
研究组 & 干预措施
quality of life questionaries
Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion)
干预措施: quality of life questionaries (Other)
quality of life questionaries
Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion)
干预措施: intravenous or oral bone antiresorptive treatments (Drug)
结局指标
主要结局
evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie
时间窗: to 6 months
evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect
次要结局
未报告次要终点