Quality of Life After Esophagectomy for Cancer - Step 1
NCT ID: NCT01738620
Last Updated: 2017-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
74 participants
INTERVENTIONAL
2013-01-31
2016-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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psychological counseling+prevention of sleep disorders in ICU
patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay
psychological counseling
prevention of sleep disorders in ICU
psychological counseling
patients will receive psychological counseling
psychological counseling
prevention of sleep disorders in ICU
interventions to prevent sleep disorders during their ICU stay
prevention of sleep disorders in ICU
standard care
patients will receive standard care
No interventions assigned to this group
Interventions
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psychological counseling
prevention of sleep disorders in ICU
Eligibility Criteria
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Inclusion Criteria
* scheduled for esophagectomy for cancer
Exclusion Criteria
* incapability to autonomously fill in questionnaires
* primary language not italian
18 Years
ALL
No
Sponsors
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Fondazione Guido Berlucchi
OTHER
Istituto Oncologico Veneto IRCCS
OTHER
University of Padova
OTHER
Responsible Party
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Principal Investigators
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Carlo Castoro, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Oncologico Veneto (IOV-IRCCS)
Locations
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Istituto Oncologico Veneto (IOV-IRCCS)
Padua, Padova, Italy
Countries
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References
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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.
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.
Other Identifiers
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QOLEC1 - step 1
Identifier Type: -
Identifier Source: org_study_id
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