Quality of Life After Esophagectomy for Cancer - Step 2
NCT ID: NCT01738633
Last Updated: 2018-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
80 participants
INTERVENTIONAL
2013-01-31
2018-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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nutritional + respirology counseling
patients will receive both nutritional and respirology counseling
nutritional counseling
respirology counseling
nutritional counseling
patients will receive nutritional counseling alone
nutritional counseling
respirology counseling
patients will receive respirology counseling alone
respirology counseling
standard care
patients will receive standard care
No interventions assigned to this group
Interventions
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nutritional counseling
respirology counseling
Eligibility Criteria
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Inclusion Criteria
* scheduled for esophagectomy for cancer
Exclusion Criteria
* incapability to autonomously fill in questionnaires
* primary language not italian
18 Years
ALL
No
Sponsors
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Fondazione Guido Berlucchi
OTHER
Veneto Institute of Oncology I.O.V.-I.R.C.C.S.
UNKNOWN
University of Padova
OTHER
Responsible Party
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Locations
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Istituto Oncologico Veneto (IOV-IRCCS)
Padua, , Italy
Countries
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Other Identifiers
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QOLEC1 - step 2
Identifier Type: -
Identifier Source: org_study_id
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