Quality of Life After Esophagectomy for Cancer - Step 1

University of Padova

Status: Terminated

Conditions: Esophageal Cancer; Quality of Life; Sleep Disturbance

Treatments: Behavioral: prevention of sleep disorders in ICU; Behavioral: psychological counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01738620

QOLEC1 - step 1

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 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.

Enrollment: 74 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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74 participants in 4 patient groups

psychological counseling+prevention of sleep disorders in ICU

Experimental group

Description:

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

Treatment:

Behavioral: prevention of sleep disorders in ICU

Behavioral: psychological counseling

psychological counseling

Experimental group

Description:

patients will receive psychological counseling

Treatment:

Behavioral: psychological counseling

prevention of sleep disorders in ICU

Experimental group

Description:

interventions to prevent sleep disorders during their ICU stay

Treatment:

Behavioral: prevention of sleep disorders in ICU

standard care

No Intervention group

Description:

patients will receive standard care