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Quality of Life After Esophagectomy for Cancer - Step 1

Primary Purpose

Esophageal Cancer, Sleep Disturbance, Quality of Life

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
psychological counseling
prevention of sleep disorders in ICU
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, sleep disturbance, 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

psychological counseling+prevention of sleep disorders in ICU

psychological counseling

prevention of sleep disorders in ICU

standard care

Arm Description

patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay

patients will receive psychological counseling

interventions to prevent sleep disorders during their ICU stay

patients will receive standard care

Outcomes

Primary Outcome Measures

items SL (sleep disorder) and QL2 of the QLQ C30

Secondary Outcome Measures

PSQI score

Full Information

First Posted
October 20, 2012
Last Updated
April 11, 2017
Sponsor
University of Padova
Collaborators
Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT01738620
Brief Title
Quality of Life After Esophagectomy for Cancer - Step 1
Official Title
Quality of Life After Esophagectomy for Cancer - QOLEC1
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
Collaborators
Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS

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 1. Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Sleep Disturbance, Quality of Life
Keywords
esophageal cancer, sleep disturbance, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
psychological counseling+prevention of sleep disorders in ICU
Arm Type
Experimental
Arm Description
patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay
Arm Title
psychological counseling
Arm Type
Experimental
Arm Description
patients will receive psychological counseling
Arm Title
prevention of sleep disorders in ICU
Arm Type
Experimental
Arm Description
interventions to prevent sleep disorders during their ICU stay
Arm Title
standard care
Arm Type
No Intervention
Arm Description
patients will receive standard care
Intervention Type
Behavioral
Intervention Name(s)
psychological counseling
Intervention Type
Behavioral
Intervention Name(s)
prevention of sleep disorders in ICU
Primary Outcome Measure Information:
Title
items SL (sleep disorder) and QL2 of the QLQ C30
Time Frame
14 days (average time to hospital discharge)
Secondary Outcome Measure Information:
Title
PSQI score
Time Frame
14 days (average time to hospital discharge)

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Castoro, MD
Organizational Affiliation
Istituto Oncologico Veneto (IOV-IRCCS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Oncologico Veneto (IOV-IRCCS)
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31464769
Citation
Geense WW, van den Boogaard M, van der Hoeven JG, Vermeulen H, Hannink G, Zegers M. Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis. Crit Care Med. 2019 Nov;47(11):1607-1618. doi: 10.1097/CCM.0000000000003974.
Results Reference
derived
PubMed Identifier
28707741
Citation
Scarpa M, Pinto E, Saraceni E, Cavallin F, Parotto M, Alfieri R, Nardi MT, Marchi MR, Cagol M, Castoro C; QOLEC Group. Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy. Br J Surg. 2017 Sep;104(10):1307-1314. doi: 10.1002/bjs.10609. Epub 2017 Jul 14.
Results Reference
derived

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Quality of Life After Esophagectomy for Cancer - Step 1

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