Quality of Life After Esophagectomy for Cancer - Step 1
Esophageal Cancer - Sleep Disturbance - Quality of Life
Conditions: official terms
Dyssomnias - Esophageal Neoplasms - Parasomnias - Sleep Disorders
Conditions: Keywords
esophageal cancer, sleep disturbance, quality of life
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Name: psychological counseling Type: Behavioral
Name: prevention of sleep disorders in ICU Type: Behavioral
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Istituto Oncologico Veneto (IOV-IRCCS)
Padova, Italy
Status: Recruiting
Contact: Carlo Castoro, MD - 049 821 1693 - carlo.castoro@unipd.it
Start Date
January 2013
Completion Date
February 2016
University of Padova
University of Padova
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page