Quality of Life After Esophagectomy for Cancer - Step 1

Study Overview
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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 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.

Official Title
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Quality of Life After Esophagectomy for Cancer - QOLEC1

Conditions
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Esophageal Cancer, Sleep Disturbance, Quality of Life

Intervention / Treatment
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* Behavioral: psychological counseling
* Behavioral: prevention of sleep disorders in ICU


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychological counseling+prevention of sleep disorders in ICU<br>patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay | Behavioral: psychological counseling<br> <br> Behavioral: prevention of sleep disorders in ICU<br> <br> |
| Experimental: psychological counseling<br>patients will receive psychological counseling | Behavioral: psychological counseling<br> <br> |
| Experimental: prevention of sleep disorders in ICU<br>interventions to prevent sleep disorders during their ICU stay | Behavioral: prevention of sleep disorders in ICU<br> <br> |
| No Intervention: standard care<br>patients will receive standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| items SL (sleep disorder) and QL2 of the QLQ C30 |  | 14 days (average time to hospital discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSQI score |  | 14 days (average time to hospital discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, sleep disturbance, quality of life