Trial Information
Quality of Life After Esophagectomy for Cancer - QOLEC1
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
items SL (sleep disorder) and QL2 of the QLQ C30
Outcome Time Frame:
14 days (average time to hospital discharge)
Safety Issue:
No
Principal Investigator
Carlo Castoro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Istituto Oncologico Veneto (IOV-IRCCS)
Authority:
Italy: Ethics Committee
Study ID:
QOLEC1 - step 1
NCT ID:
NCT01738620
Start Date:
October 2012
Completion Date:
December 2014
Related Keywords:
- Esophageal Cancer
- Sleep Disturbance
- Quality of Life
- esophageal cancer
- sleep disturbance
- quality of life
- Esophageal Diseases
- Esophageal Neoplasms
- Sleep Disorders
- Dyssomnias
- Parasomnias