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Quality of Life After Esophagectomy for Cancer - Step 1

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ClinicalTrials.gov Identifier: NCT01738620
Recruitment Status : Terminated (In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.)
First Posted : November 30, 2012
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
Fondazione Guido Berlucchi
Istituto Oncologico Veneto IRCCS
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Sleep Disturbance Quality of Life Behavioral: psychological counseling Behavioral: prevention of sleep disorders in ICU Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality of Life After Esophagectomy for Cancer - QOLEC1
Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Arm Intervention/treatment
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
Behavioral: psychological counseling Behavioral: prevention of sleep disorders in ICU
Experimental: psychological counseling
patients will receive psychological counseling
Behavioral: psychological counseling
Experimental: prevention of sleep disorders in ICU
interventions to prevent sleep disorders during their ICU stay
Behavioral: prevention of sleep disorders in ICU
No Intervention: standard care
patients will receive standard care



Primary Outcome Measures :
  1. items SL (sleep disorder) and QL2 of the QLQ C30 [ Time Frame: 14 days (average time to hospital discharge) ]

Secondary Outcome Measures :
  1. PSQI score [ Time Frame: 14 days (average time to hospital discharge) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738620


Locations
Italy
Istituto Oncologico Veneto (IOV-IRCCS)
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Fondazione Guido Berlucchi
Istituto Oncologico Veneto IRCCS
Investigators
Principal Investigator: Carlo Castoro, MD Istituto Oncologico Veneto (IOV-IRCCS)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01738620     History of Changes
Other Study ID Numbers: QOLEC1 - step 1
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by University of Padova:
esophageal cancer
sleep disturbance
quality of life

Additional relevant MeSH terms:
Esophageal Neoplasms
Dyssomnias
Sleep Wake Disorders
Parasomnias
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms