Quality of Life After Esophagectomy for Cancer - Step 2
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
- 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 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)
