Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 9:44 PM
Study NCT ID:
NCT01738633
Status:
TERMINATED
Last Update Posted:
2018-05-23
First Post:
2012-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Esophagectomy for Cancer - Step 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'Surgical Unit closed and moved.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-21', 'studyFirstSubmitDate': '2012-10-20', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30', 'timeFrame': '1 month after surgical operation'}], 'secondaryOutcomes': [{'measure': 'item EA (eating) of OES18', 'timeFrame': '1 month after surgical operation'}, {'measure': 'items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30', 'timeFrame': '3 months after surgical operation'}, {'measure': 'item EA (eating) of OES18', 'timeFrame': '3 months after surgical operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Esophageal Cancer', 'Quality of Life'], 'conditions': ['Esophageal Cancer', 'Quality of Life']}, 'descriptionModule': {'briefSummary': '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.\n\nThe study is divided into two steps.\n\nThis is step 2.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18 years old\n* scheduled for esophagectomy for cancer\n\nExclusion Criteria:\n\n* age below 18 years old\n* incapability to autonomously fill in questionnaires\n* primary language not italian'}, 'identificationModule': {'nctId': 'NCT01738633', 'briefTitle': 'Quality of Life After Esophagectomy for Cancer - Step 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Quality of Life After Esophagectomy for Cancer - Step 2', 'orgStudyIdInfo': {'id': 'QOLEC1 - step 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nutritional + respirology counseling', 'description': 'patients will receive both nutritional and respirology counseling', 'interventionNames': ['Behavioral: nutritional counseling', 'Behavioral: respirology counseling']}, {'type': 'EXPERIMENTAL', 'label': 'nutritional counseling', 'description': 'patients will receive nutritional counseling alone', 'interventionNames': ['Behavioral: nutritional counseling']}, {'type': 'EXPERIMENTAL', 'label': 'respirology counseling', 'description': 'patients will receive respirology counseling alone', 'interventionNames': ['Behavioral: respirology counseling']}, {'type': 'NO_INTERVENTION', 'label': 'standard care', 'description': 'patients will receive standard care'}], 'interventions': [{'name': 'nutritional counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['nutritional + respirology counseling', 'nutritional counseling']}, {'name': 'respirology counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['nutritional + respirology counseling', 'respirology counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Istituto Oncologico Veneto (IOV-IRCCS)', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Guido Berlucchi', 'class': 'OTHER'}, {'name': 'Veneto Institute of Oncology I.O.V.-I.R.C.C.S.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}