Quality of Life After Esophagectomy for Cancer - QOLEC1
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
- 否
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))
