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Spots Global Cancer Trial Database for Quality of Life After Esophagectomy for Cancer - Step 1

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Trial Identification

Brief Title: Quality of Life After Esophagectomy for Cancer - Step 1

Official Title: Quality of Life After Esophagectomy for Cancer - QOLEC1

Study ID: NCT01738620

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Istituto Oncologico Veneto (IOV-IRCCS), Padova, , Italy

Contact Details

Name: Carlo Castoro, MD

Affiliation: Istituto Oncologico Veneto (IOV-IRCCS)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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