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Quality of Life After Esophagectomy for Cancer - Step 2

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ClinicalTrials.gov Identifier: NCT01738633
Recruitment Status : Recruiting
First Posted : November 30, 2012
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):

Study Description
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 2.

At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.

Condition or disease Intervention/treatment
Esophageal Cancer Quality of Life Behavioral: nutritional counseling Behavioral: respirology counseling

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality of Life After Esophagectomy for Cancer - Step 2
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: nutritional + respirology counseling
patients will receive both nutritional and respirology counseling
Behavioral: nutritional counseling Behavioral: respirology counseling
Experimental: nutritional counseling
patients will receive nutritional counseling alone
Behavioral: nutritional counseling
Experimental: respirology counseling
patients will receive respirology counseling alone
Behavioral: respirology counseling
No Intervention: standard care
patients will receive standard care

Outcome Measures

Primary Outcome Measures :
  1. items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30 [ Time Frame: 1 month after surgical operation ]

Secondary Outcome Measures :
  1. item EA (eating) of OES18 [ Time Frame: 1 month after surgical operation ]
  2. items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30 [ Time Frame: 3 months after surgical operation ]
  3. item EA (eating) of OES18 [ Time Frame: 3 months after surgical operation ]

Eligibility Criteria

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

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

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): NCT01738633

Contact: Carlo Castoro, MD + 39 049 821 1693 carlo.castoro@unipd.it

Istituto Oncologico Veneto (IOV-IRCCS) Recruiting
Padova, Italy, 35128
Contact: Carlo Castoro, MD    +39 049 821 1693    carlo.castoro@unipd.it   
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: Elisabetta Saraceni, MD         
Sub-Investigator: Fabio Baratto, MD         
Sub-Investigator: Luca M Sadeeh, MD         
Sponsors and Collaborators
University of Padova
Fondazione Guido Berlucchi
Veneto Institute of Oncology I.O.V.-I.R.C.C.S.
More Information

Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01738633     History of Changes
Other Study ID Numbers: QOLEC1 - step 2
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
Quality of Life

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases