NCT01738633

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

4.4 years

First QC Date

October 20, 2012

Last Update Submit

May 21, 2018

Conditions

Esophageal CancerQuality of Life

Keywords

Esophageal CancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30

    1 month after surgical operation

Secondary Outcomes (3)

  • item EA (eating) of OES18

    1 month after surgical operation

  • items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30

    3 months after surgical operation

  • item EA (eating) of OES18

    3 months after surgical operation

Study Arms (4)

nutritional + respirology counseling

EXPERIMENTAL

patients will receive both nutritional and respirology counseling

Behavioral: nutritional counselingBehavioral: respirology counseling

nutritional counseling

EXPERIMENTAL

patients will receive nutritional counseling alone

Behavioral: nutritional counseling

respirology counseling

EXPERIMENTAL

patients will receive respirology counseling alone

Behavioral: respirology counseling

standard care

NO INTERVENTION

patients will receive standard care

Interventions

nutritional counselingBEHAVIORAL
nutritional + respirology counselingnutritional counseling
respirology counselingBEHAVIORAL
nutritional + respirology counselingrespirology counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 18 years old
  • scheduled for esophagectomy for cancer

You may not qualify if:

  • age below 18 years old
  • incapability to autonomously fill in questionnaires
  • primary language not italian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Oncologico Veneto (IOV-IRCCS)

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2012

First Posted

November 30, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2017

Study Completion

April 1, 2018

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

IT(1)