Quality of Life After Esophagectomy for Cancer - Step 2
Primary Purpose
Esophageal Cancer, Quality of Life
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
nutritional counseling
respirology counseling
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Quality of Life
Eligibility 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
Sites / Locations
- Istituto Oncologico Veneto (IOV-IRCCS)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
nutritional + respirology counseling
nutritional counseling
respirology counseling
standard care
Arm Description
patients will receive both nutritional and respirology counseling
patients will receive nutritional counseling alone
patients will receive respirology counseling alone
patients will receive standard care
Outcomes
Primary Outcome Measures
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Secondary Outcome Measures
item EA (eating) of OES18
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
item EA (eating) of OES18
Full Information
NCT ID
NCT01738633
First Posted
October 20, 2012
Last Updated
May 21, 2018
Sponsor
University of Padova
Collaborators
Fondazione Guido Berlucchi, Veneto Institute of Oncology I.O.V.-I.R.C.C.S.
1. Study Identification
Unique Protocol Identification Number
NCT01738633
Brief Title
Quality of Life After Esophagectomy for Cancer - Step 2
Official Title
Quality of Life After Esophagectomy for Cancer - Step 2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Surgical Unit closed and moved.
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
Collaborators
Fondazione Guido Berlucchi, Veneto Institute of Oncology I.O.V.-I.R.C.C.S.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Quality of Life
Keywords
Esophageal Cancer, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nutritional + respirology counseling
Arm Type
Experimental
Arm Description
patients will receive both nutritional and respirology counseling
Arm Title
nutritional counseling
Arm Type
Experimental
Arm Description
patients will receive nutritional counseling alone
Arm Title
respirology counseling
Arm Type
Experimental
Arm Description
patients will receive respirology counseling alone
Arm Title
standard care
Arm Type
No Intervention
Arm Description
patients will receive standard care
Intervention Type
Behavioral
Intervention Name(s)
nutritional counseling
Intervention Type
Behavioral
Intervention Name(s)
respirology counseling
Primary Outcome Measure Information:
Title
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time Frame
1 month after surgical operation
Secondary Outcome Measure Information:
Title
item EA (eating) of OES18
Time Frame
1 month after surgical operation
Title
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time Frame
3 months after surgical operation
Title
item EA (eating) of OES18
Time Frame
3 months after surgical operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Istituto Oncologico Veneto (IOV-IRCCS)
City
Padova
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Quality of Life After Esophagectomy for Cancer - Step 2
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