Quality of Life After Esophagectomy for Cancer – Step 1

Overview

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.

Full Title of Study: “Quality of Life After Esophagectomy for Cancer – QOLEC1″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Interventions

  • Behavioral: psychological counseling
  • Behavioral: prevention of sleep disorders in ICU

Arms, Groups and Cohorts

  • Experimental: psychological counseling+prevention of sleep disorders in ICU
    • patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay
  • Experimental: psychological counseling
    • patients will receive psychological counseling
  • Experimental: prevention of sleep disorders in ICU
    • interventions to prevent sleep disorders during their ICU stay
  • No Intervention: standard care
    • patients will receive standard care

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • PSQI score
    • Time Frame: 14 days (average time to hospital discharge)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Padova
  • Collaborator
    • Fondazione Guido Berlucchi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carlo Castoro, MD, Principal Investigator, Istituto Oncologico Veneto (IOV-IRCCS)

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