Quality of Life After Esophagectomy for Cancer - Step 1

Quality of Life Clinical Trial

Official title:

Quality of Life After Esophagectomy for Cancer - QOLEC1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01738620
• Other study ID #: QOLEC1 - step 1
• Status: Terminated
• Phase: N/A
• First received: October 20, 2012
• Last updated: April 11, 2017
• Start date: January 2013
• Est. completion date: February 2016

Study information

• Verified date: April 2017
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• 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

• Dyssomnias
• Esophageal Cancer
• Esophageal Neoplasms
• Parasomnias
• Quality of Life
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• psychological counseling

• prevention of sleep disorders in ICU

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Padova	Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	items SL (sleep disorder) and QL2 of the QLQ C30		14 days (average time to hospital discharge)
Secondary	PSQI score		14 days (average time to hospital discharge)