Quality of Life After Esophagectomy for Cancer - Step 1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01738620|
Recruitment Status : Terminated (In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.)
First Posted : November 30, 2012
Last Update Posted : April 12, 2017
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.
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Sleep Disturbance Quality of Life||Behavioral: psychological counseling Behavioral: prevention of sleep disorders in ICU|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Quality of Life After Esophagectomy for Cancer - QOLEC1|
|Study Start Date :||January 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||February 2016|
Experimental: psychological counseling+prevention of sleep disorders in ICU
patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay
|Behavioral: psychological counseling Behavioral: prevention of sleep disorders in ICU|
Experimental: psychological counseling
patients will receive psychological counseling
|Behavioral: psychological counseling|
Experimental: prevention of sleep disorders in ICU
interventions to prevent sleep disorders during their ICU stay
|Behavioral: prevention of sleep disorders in ICU|
No Intervention: standard care
patients will receive standard care
- items SL (sleep disorder) and QL2 of the QLQ C30 [ Time Frame: 14 days (average time to hospital discharge) ]
- PSQI score [ Time Frame: 14 days (average time to hospital discharge) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738620
|Istituto Oncologico Veneto (IOV-IRCCS)|
|Padova, Italy, 35128|
|Principal Investigator:||Carlo Castoro, MD||Istituto Oncologico Veneto (IOV-IRCCS)|