Quality of Life After Esophagectomy for Cancer - Step 2

NCT ID: NCT01738633

Last Updated: 2018-05-23

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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nutritional + respirology counseling

patients will receive both nutritional and respirology counseling

Group Type EXPERIMENTAL

nutritional counseling

Intervention Type BEHAVIORAL

respirology counseling

Intervention Type BEHAVIORAL

nutritional counseling

patients will receive nutritional counseling alone

Group Type EXPERIMENTAL

nutritional counseling

Intervention Type BEHAVIORAL

respirology counseling

patients will receive respirology counseling alone

Group Type EXPERIMENTAL

respirology counseling

Intervention Type BEHAVIORAL

standard care

patients will receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nutritional counseling

Intervention Type BEHAVIORAL

respirology counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Guido Berlucchi

OTHER

Sponsor Role collaborator

Veneto Institute of Oncology I.O.V.-I.R.C.C.S.

UNKNOWN

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Oncologico Veneto (IOV-IRCCS)

Padua, , Italy

Site Status

Countries

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Italy

Other Identifiers

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QOLEC1 - step 2

Identifier Type: -

Identifier Source: org_study_id

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