Quality of Life After Esophagectomy for Cancer - Step 2
Conditions
Esophageal Cancer - Quality of Life
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal Cancer, Quality of Life
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: nutritional counseling Type: Behavioral
Name: respirology counseling Type: Behavioral
Overall Status
Recruiting
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 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.
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
Location
Istituto Oncologico Veneto (IOV-IRCCS)
Padova, Italy
Status: Recruiting
Contact: Carlo Castoro, MD - +39 049 821 1693 - carlo.castoro@unipd.it
Start Date
January 2013
Completion Date
February 2016
Sponsors
University of Padova
Source
University of Padova
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page