Quality of Life After Esophagectomy for Cancer - Step 1

Not Applicable

Terminated

• Conditions: Quality of Life; Esophageal Cancer; Sleep Disturbance
• Interventions: Behavioral: psychological counseling; Behavioral: prevention of sleep disorders in ICU

• Registration Number: NCT01738620
• 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 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.

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: 2015-12
• Study Completion: 2016-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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
psychological counseling	psychological counseling	patients will receive psychological counseling
psychological counseling+prevention of sleep disorders in ICU	psychological counseling	patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay
prevention of sleep disorders in ICU	prevention of sleep disorders in ICU	interventions to prevent sleep disorders during their ICU stay
psychological counseling+prevention of sleep disorders in ICU	prevention of sleep disorders in ICU	patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay

Primary Outcome Measures

Name	Time	Method
items SL (sleep disorder) and QL2 of the QLQ C30	14 days (average time to hospital discharge)

Secondary Outcome Measures

Name	Time	Method
PSQI score	14 days (average time to hospital discharge)

Trial Locations

Locations (1)

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