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临床试验/NCT01738633
NCT01738633终止不适用

Quality of Life After Esophagectomy for Cancer - Step 2

University of Padova2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
80
试验地点
2
主要终点
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30

研究概览

简要总结

Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.

The study is divided into two steps.

This is step 2.

At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • age above 18 years old
  • scheduled for esophagectomy for cancer

排除标准

  • age below 18 years old
  • incapability to autonomously fill in questionnaires
  • primary language not italian

结局指标

主要结局

items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30

时间窗: 1 month after surgical operation

次要结局

  • item EA (eating) of OES18(3 months after surgical operation)
  • items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30(3 months after surgical operation)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (2)

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