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Quality of Life After Esophagectomy for Cancer - Step 1

Quality of Life After Esophagectomy for Cancer - QOLEC1

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738620
Enrollment
74
Registered
2012-11-30
Start date
2013-01-31
Completion date
2016-02-29
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Quality of Life, Sleep Disturbance

Keywords

esophageal cancer, sleep disturbance, quality of life

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.

Interventions

BEHAVIORALprevention of sleep disorders in ICU

Sponsors

Fondazione Guido Berlucchi
CollaboratorOTHER
Istituto Oncologico Veneto IRCCS
CollaboratorOTHER
University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
items SL (sleep disorder) and QL2 of the QLQ C3014 days (average time to hospital discharge)

Secondary

MeasureTime frame
PSQI score14 days (average time to hospital discharge)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026