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In October 2015 ICU's setting completely changed from an open concept 8-beds unit to a single bed isolated room.
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| Name | Class |
|---|---|
| Fondazione Guido Berlucchi | OTHER |
| Istituto Oncologico Veneto IRCCS | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| psychological counseling+prevention of sleep disorders in ICU | Experimental | patients will receive both psychological counseling and interventions to prevent sleep disorders during their ICU stay |
|
| psychological counseling | Experimental | patients will receive psychological counseling |
|
| prevention of sleep disorders in ICU | Experimental | interventions to prevent sleep disorders during their ICU stay |
|
| standard care | No Intervention | patients will receive standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| psychological counseling | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| items SL (sleep disorder) and QL2 of the QLQ C30 | 14 days (average time to hospital discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| PSQI score | 14 days (average time to hospital discharge) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Castoro, MD | Istituto Oncologico Veneto (IOV-IRCCS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Oncologico Veneto (IOV-IRCCS) | Padova | Padova | 35128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31464769 | Derived | 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. | |
| 28707741 | Derived |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007362 | Intensive Care Units |
| ID | Term |
|---|---|
| D006757 | Hospital Units |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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| prevention of sleep disorders in ICU |
| Behavioral |
|
| 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. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |