NCT01738620

Quality of Life After Esophagectomy for Cancer - Step 1

Quality of Life After Esophagectomy for Cancer - QOLEC1

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Esophageal Cancer
• Sleep Disturbance
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	psychological counseling
BEHAVIORAL	prevention of sleep disorders in ICU

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2012-11-30
• Last updated: 2017-04-12

Locations

1 site across 1 country: Italy