NCT00290095已完成不适用
Quality of Life in Patients With Multiple Myeloma
Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2006年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.
详细描述
Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. In the absence of curative treatment, the aim of the therapy is not only to induce an objective response and a prolongation of survival but also to improve the patients quality of life.
This project will raise two problems which make QoL-data hard to interpret
- In a clinical trial where many patients are included, statistically significant differences are obtained. However, there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in QoL. A crucial task for clinicians in interpreting trial-based QoL results is to determine if the observed change is clinically important to the patient.
- When measuring changes in QoL in a pretest-posttest design,response shift can affect results. Patients with advanced disease can report surprisingly good QoL.Including response shift into quality of life research would allow a better understanding of changes in the QoL that patients report.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Multiple Myeloma
- •Age > 18 years
- •Informed consent
排除标准
- •Terminal illness with life expectancy less than 3 months
- •Unable to fill in a questionnaire in norwegian
研究者
研究点 (1)
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