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Clinical Trials/NCT01738620
NCT01738620
Terminated
Not Applicable

Quality of Life After Esophagectomy for Cancer - QOLEC1

University of Padova1 site in 1 country74 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
University of Padova
Enrollment
74
Locations
1
Primary Endpoint
items SL (sleep disorder) and QL2 of the QLQ C30
Status
Terminated
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age above 18 years old
  • scheduled for esophagectomy for cancer

Exclusion Criteria

  • age below 18 years old
  • incapability to autonomously fill in questionnaires
  • primary language not italian

Outcomes

Primary Outcomes

items SL (sleep disorder) and QL2 of the QLQ C30

Time Frame: 14 days (average time to hospital discharge)

Secondary Outcomes

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

Study Sites (1)

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