Quality of Life After Esophagectomy for Cancer - Step 2

May 21, 2018 updated by: University of Padova

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 2.

At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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
No Intervention: standard care
patients will receive standard care
Experimental: nutritional + respirology counseling
patients will receive both nutritional and respirology counseling
Behavioral: nutritional counseling
Behavioral: respirology counseling
Experimental: nutritional counseling
patients will receive nutritional counseling alone
Behavioral: nutritional counseling
Experimental: respirology counseling
patients will receive respirology counseling alone
Behavioral: respirology counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time Frame: 1 month after surgical operation
1 month after surgical operation

Secondary Outcome Measures

Outcome Measure
Time Frame
item EA (eating) of OES18
Time Frame: 1 month after surgical operation
1 month after surgical operation
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time Frame: 3 months after surgical operation
3 months after surgical operation
item EA (eating) of OES18
Time Frame: 3 months after surgical operation
3 months after surgical operation

Collaborators and Investigators

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

Sponsor

University of Padova

Collaborators

Fondazione Guido Berlucchi
Veneto Institute of Oncology I.O.V.-I.R.C.C.S.

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)

June 1, 2017

Study Completion (Actual)

April 1, 2018

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)

May 23, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QOLEC1 - step 2

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.

Clinical Trials on Quality of Life

Clinical Trials on nutritional counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe