Quality of Life After Esophagectomy for Cancer - Step 2

University of Padova

Status: Terminated

Conditions: Esophageal Cancer; Quality of Life

Treatments: Behavioral: respirology counseling; Behavioral: nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01738633

QOLEC1 - step 2

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

nutritional + respirology counseling

Experimental group

Description:

patients will receive both nutritional and respirology counseling

Treatment:

Behavioral: nutritional counseling

Behavioral: respirology counseling

nutritional counseling

Experimental group

Description:

patients will receive nutritional counseling alone

Treatment:

Behavioral: nutritional counseling

respirology counseling

Experimental group

Description:

patients will receive respirology counseling alone

Treatment:

Behavioral: respirology counseling

standard care

No Intervention group

Description:

patients will receive standard care