Quality of Life After Esophagectomy for Cancer - Step 2

Quality of Life Clinical Trial

Official title:

Quality of Life After Esophagectomy for Cancer - Step 2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01738633
• Other study ID #: QOLEC1 - step 2
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: April 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Quality of Life

Intervention

Behavioral:
• nutritional counseling

• respirology counseling

Locations

Country	Name	City	State
Italy	Istituto Oncologico Veneto (IOV-IRCCS)	Padova

Sponsors (3)

Lead Sponsor	Collaborator
University of Padova	Fondazione Guido Berlucchi, Veneto Institute of Oncology I.O.V.-I.R.C.C.S.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30		1 month after surgical operation
Secondary	item EA (eating) of OES18		1 month after surgical operation
Secondary	items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30		3 months after surgical operation
Secondary	item EA (eating) of OES18		3 months after surgical operation