Quality of Life After Esophagectomy for Cancer - Step 2

Not Applicable

Terminated

• Conditions: Esophageal Cancer; Quality of Life
• Interventions: Behavioral: nutritional counseling; Behavioral: respirology counseling

• Registration Number: NCT01738633
• Lead Sponsor: University of Padova

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-20
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Study Start: 2013-01
• Primary Completion: 2017-06
• Study Completion: 2018-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutritional counseling	nutritional counseling	patients will receive nutritional counseling alone
nutritional + respirology counseling	respirology counseling	patients will receive both nutritional and respirology counseling
nutritional + respirology counseling	nutritional counseling	patients will receive both nutritional and respirology counseling
respirology counseling	respirology counseling	patients will receive respirology counseling alone

Primary Outcome Measures

Name	Time	Method
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30	1 month after surgical operation

Secondary Outcome Measures

Name	Time	Method
item EA (eating) of OES18	3 months after surgical operation
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30	3 months after surgical operation

Trial Locations

Locations (1)

Istituto Oncologico Veneto (IOV-IRCCS); 🇮🇹 Padova, Italy