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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
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.
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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

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Quality of Life After Esophagectomy for Cancer - Step 2

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