Quality of Life After Esophagectomy for Cancer - Step 1

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Padova
Sponsor:
Collaborators:
Berlucchi Foundation, Brescia, Italy
Istituto Oncologico Veneto IRCCS
Information provided by (Responsible Party):
University of Padova
ClinicalTrials.gov Identifier:
NCT01738620
First received: October 20, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention
Esophageal Cancer
Sleep Disturbance
Quality of Life
Behavioral: psychological counseling
Behavioral: prevention of sleep disorders in ICU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality of Life After Esophagectomy for Cancer - QOLEC1

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • items SL (sleep disorder) and QL2 of the QLQ C30 [ Time Frame: 14 days (average time to hospital discharge) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSQI score [ Time Frame: 14 days (average time to hospital discharge) ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738620

Contacts
Contact: Carlo Castoro, MD 049 821 1693 carlo.castoro@unipd.it

Locations
Italy
Istituto Oncologico Veneto (IOV-IRCCS) Recruiting
Padova, Italy, 35128
Contact: Carlo Castoro, MD    049 821 1693    carlo.castoro@unipd.it   
Principal Investigator: Carlo Castoro, MD         
Sub-Investigator: Marco Scarpa, MD         
Sub-Investigator: Matteo Cagol, MD         
Sub-Investigator: Rita Alfieri, MD         
Sub-Investigator: Lorenza Caregaro, MD         
Sub-Investigator: Mariateresa Nardi, MD         
Sub-Investigator: Rita Marchi, MD         
Sub-Investigator: Andrea Vianello, MD         
Sub-Investigator: Eleonora Pinto, Psy. D.         
Sub-Investigator: Matteo Parotto, MD         
Sub-Investigator: Fabio Baratto, MD         
Sub-Investigator: Elisabetta Saraceni, MD         
Sub-Investigator: Luca M Saadeh, MD         
Sponsors and Collaborators
University of Padova
Berlucchi Foundation, Brescia, Italy
Istituto Oncologico Veneto IRCCS
Investigators
Principal Investigator: Carlo Castoro, MD Istituto Oncologico Veneto (IOV-IRCCS)
  More Information

No publications provided

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01738620     History of Changes
Other Study ID Numbers: QOLEC1 - step 1
Study First Received: October 20, 2012
Last Updated: February 5, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Esophageal Neoplasms
Dyssomnias
Sleep 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

ClinicalTrials.gov processed this record on October 01, 2014