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临床试验/NCT01738620
NCT01738620终止不适用

Quality of Life After Esophagectomy for Cancer - QOLEC1

University of Padova2 个研究点 分布在 1 个国家目标入组 74 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
74
试验地点
2
主要终点
items SL (sleep disorder) 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 1.

Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.

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 SL (sleep disorder) and QL2 of the QLQ C30

时间窗: 14 days (average time to hospital discharge)

次要结局

  • PSQI score(14 days (average time to hospital discharge))

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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