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Quality of Life After Esophagectomy for Cancer - Step 1

NCT01738620 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-04-12

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer
  • Sleep Disturbance
  • Quality of Life

Interventions

BEHAVIORAL

psychological counseling

BEHAVIORAL

prevention of sleep disorders in ICU

Sponsors & Collaborators

  • Fondazione Guido Berlucchi

    collaborator OTHER

  • Istituto Oncologico Veneto IRCCS

    collaborator OTHER

  • University of Padova

    lead OTHER

Principal Investigators

  • Carlo Castoro, MD · Istituto Oncologico Veneto (IOV-IRCCS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738620 on ClinicalTrials.gov