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Surgical Unit closed and moved.
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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 2.
At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutritional + respirology counseling | Experimental | patients will receive both nutritional and respirology counseling |
|
| nutritional counseling | Experimental | patients will receive nutritional counseling alone |
|
| respirology counseling | Experimental | patients will receive respirology counseling alone |
|
| standard care | No Intervention | patients will receive standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional counseling | Behavioral |
| ||
| respirology counseling |
| Measure | Description | Time Frame |
|---|---|---|
| items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30 | 1 month after surgical operation |
| Measure | Description | Time Frame |
|---|---|---|
| item EA (eating) of OES18 | 1 month after surgical operation | |
| items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30 | 3 months after surgical operation | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Oncologico Veneto (IOV-IRCCS) | Padova | 35128 | Italy |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Behavioral |
|
| item EA (eating) of OES18 |
| 3 months after surgical operation |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |