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临床试验/NCT00290095
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

  1. 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.
  2. 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

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

发起方
Ullevaal University Hospital
申办方类型
Other

研究点 (1)

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Quality of Life in Patients With Multiple Myeloma | 临床试验