Clinical trial NCT01738620: Quality of Life After Esophagectomy for Cancer - Step 1
Official title: Quality of Life After Esophagectomy for Cancer - QOLEC1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Sleep Disturbance
Quality of Life
Keywords: esophageal cancer
sleep disturbance
quality of life
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Fondazione Guido Berlucchi
name: Istituto Oncologico Veneto IRCCS
First posted: 2012-11-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: items SL (sleep disorder) and QL2 of the QLQ C30
timeFrame: 14 days (average time to hospital discharge)
Secondary outcomes:
measure: PSQI score
timeFrame: 14 days (average time to hospital discharge)
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto (IOV-IRCCS)
Study officials:
affiliation: Istituto Oncologico Veneto (IOV-IRCCS)
name: Carlo Castoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geense WW, van den Boogaard M, van der Hoeven JG, Vermeulen H, Hannink G, Zegers M. Nonpharmacologic Interventions to Prevent or Mitigate Adverse Long-Term Outcomes Among ICU Survivors: A Systematic Review and Meta-Analysis. Crit Care Med. 2019 Nov;47(11):1607-1618. doi: 10.1097/CCM.0000000000003974.
citation: Scarpa M, Pinto E, Saraceni E, Cavallin F, Parotto M, Alfieri R, Nardi MT, Marchi MR, Cagol M, Castoro C; QOLEC Group. Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy. Br J Surg. 2017 Sep;104(10):1307-1314. doi: 10.1002/bjs.10609. Epub 2017 Jul 14.