NCT01738620

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration 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
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

October 20, 2012

Last Update Submit

April 11, 2017

Conditions

Esophageal CancerSleep DisturbanceQuality of Life

Keywords

esophageal cancersleep disturbancequality of life

Outcome Measures

Primary Outcomes (1)

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

    14 days (average time to hospital discharge)

Secondary Outcomes (1)

  • PSQI score

    14 days (average time to hospital discharge)

Study Arms (4)

psychological counseling+prevention of sleep disorders in ICU

EXPERIMENTAL

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

Behavioral: psychological counselingBehavioral: prevention of sleep disorders in ICU

psychological counseling

EXPERIMENTAL

patients will receive psychological counseling

Behavioral: psychological counseling

prevention of sleep disorders in ICU

EXPERIMENTAL

interventions to prevent sleep disorders during their ICU stay

Behavioral: prevention of sleep disorders in ICU

standard care

NO INTERVENTION

patients will receive standard care

Interventions

psychological counselingBEHAVIORAL
psychological counselingpsychological counseling+prevention of sleep disorders in ICU
prevention of sleep disorders in ICUBEHAVIORAL
prevention of sleep disorders in ICUpsychological counseling+prevention of sleep disorders in ICU

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, Padova, 35128, Italy

Location

Related Publications (2)

  • 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.

    PMID: 31464769DERIVED

  • 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.

    PMID: 28707741DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsParasomnias

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Hospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Carlo Castoro, MD

    Istituto Oncologico Veneto (IOV-IRCCS)

    PRINCIPAL INVESTIGATOR

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

December 1, 2015

Study Completion

February 1, 2016

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

IT(1)