Quality of Life After Esophagectomy for Cancer - Step 2

Study Overview
=================
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.

Official Title
-----------------
Quality of Life After Esophagectomy for Cancer - Step 2

Conditions
-----------------
Esophageal Cancer, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: nutritional counseling
* Behavioral: respirology counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional + respirology counseling<br>patients will receive both nutritional and respirology counseling | Behavioral: nutritional counseling<br> <br> Behavioral: respirology counseling<br> <br> |
| Experimental: nutritional counseling<br>patients will receive nutritional counseling alone | Behavioral: nutritional counseling<br> <br> |
| Experimental: respirology counseling<br>patients will receive respirology counseling alone | Behavioral: respirology counseling<br> <br> |
| No Intervention: standard care<br>patients will receive standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30 |  | 1 month after surgical operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Cancer, Quality of Life