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临床试验/NCT01555502
NCT01555502已完成不适用

Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer

University of Alberta1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Health related Quality of life

研究概览

简要总结

To test the effect of post operative complications on the health related quality of life (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer (NSCLC).

The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery) using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications.

Post operative complications will be assess while the patients in the hospital on a daily basis using the Clavien classification system for surgical complications.

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

入选标准

  • Adults (more than 18 years)
  • early stage NSCLC
  • speak English
  • No hearing/Speaking difficulties
  • Able to walk without assistance
  • Surgery via the VATS approach

排除标准

  • Less than 18 years old
  • Metastatic disease to the lung
  • Benign Lung disease
  • Advanced NSCLC
  • Small Cell Lung Cancer
  • Non English speakers
  • Walking/Hearing/Speaking difficulties

结局指标

主要结局

Health related Quality of life

时间窗: Change in health related quality of life at 2 weeks. Change of Health Related Quality of Life at 4 weeks. Change in Health Related Quality of Life at 8 weeks. Change in Health Related Quality of Life at 12 weeks.

Health Related Quality of Life will be assessed using the SF-36, EQ-5D and QLQ30/13 questionnaires.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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