Quality of Life Clinical Trial
Official title:
Quality of Life After Esophagectomy for Cancer - QOLEC1
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.
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