Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
Study NCT ID:
NCT01367795
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2010-07-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2010-07-14', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life 4 weeks after palliative surgery', 'timeFrame': '4 weeks after palliative surgery', 'description': 'Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).'}], 'secondaryOutcomes': [{'measure': 'duration of stay in hospital', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks'}, {'measure': 'duration of stay in an intensive care unit', 'timeFrame': 'participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days'}, {'measure': 'complications', 'timeFrame': 'the participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'Complications will be recorded following the Clavien-Dindo classification of surgical complications. This 5-scale classification is based on the type of therapy needed to correct the complications.'}, {'measure': 'reoperations', 'timeFrame': 'the participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'The need for reoperations is generally part of the 5-class complication scale by Clavien and Dindo, which we are using to record complications. Reoperations (class IIIb in the classification of complications) are recorded seperately.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['palliation', 'quality of life', 'surgery', 'surgery; palliative', 'lifestyle'], 'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). The investigators will also observe patients with conservative treatment.', 'detailedDescription': 'What is the impact on quality of life by operations in symptomatic advanced tumor disease ? After informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. The investigators will assess Quality of life with the EORTC QLQ C30-questionnaire and collect data about the disease an the actual state of the patients.\n\nBy the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital.\n\nThe questionnaire will be completed after 4 and 12 weeks as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in a known tumorrelated palliative situation will be included when an operation is discussed for relieve of symptomatic localised tumor growth . Patients will be recruited from clinics or the emergency room.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* tumor patients within a known palliative situation, patients do know about the absence of a curative treatment\n* patients are symptomatic because of localized tumor growth\n* patients having an operation for symptom relief or treated without surgery\n\nExclusion Criteria:\n\n* patients with an only intraoperatively seen palliative tumor disease\n* debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage)\n* dementia, age ≤ 18, barrier of speech'}, 'identificationModule': {'nctId': 'NCT01367795', 'briefTitle': 'Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life', 'orgStudyIdInfo': {'id': 'EK 10/10'}, 'secondaryIdInfos': [{'id': 'EK 2011/070', 'type': 'OTHER', 'domain': 'Ethikkommission Aargau/ Solothurn'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'palliative tumor disease', 'description': 'Patients in a known palliative setting with symptoms due to tumor growth.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2501', 'city': 'Basel', 'state': 'Basel', 'country': 'Switzerland', 'facility': 'Hospital Biel, Department for Surgery', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '4460', 'city': 'Olten', 'state': 'Canton of Solothurn', 'country': 'Switzerland', 'facility': 'Kantonsspital Olten, Department for Surgery', 'geoPoint': {'lat': 47.34999, 'lon': 7.90329}}], 'overallOfficials': [{'name': 'Carsten T. Viehl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, University Hospital of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kantonsspital Olten', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}