Quality of Life After Esophagectomy for Cancer - Step 1

April 11, 2017 updated by: University of Padova

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto (IOV-IRCCS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: psychological counseling+prevention of sleep disorders in ICU
patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay
Behavioral: psychological counseling
Behavioral: prevention of sleep disorders in ICU
Experimental: psychological counseling
patients will receive psychological counseling
Behavioral: psychological counseling
Experimental: prevention of sleep disorders in ICU
interventions to prevent sleep disorders during their ICU stay
Behavioral: prevention of sleep disorders in ICU
No Intervention: standard care
patients will receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
items SL (sleep disorder) and QL2 of the QLQ C30
Time Frame: 14 days (average time to hospital discharge)
14 days (average time to hospital discharge)

Secondary Outcome Measures

Outcome Measure
Time Frame
PSQI score
Time Frame: 14 days (average time to hospital discharge)
14 days (average time to hospital discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Collaborators

Istituto Oncologico Veneto IRCCS
Fondazione Guido Berlucchi

Investigators

  • Principal Investigator: Carlo Castoro, MD, Istituto Oncologico Veneto (IOV-IRCCS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 20, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QOLEC1 - step 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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