Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01555502
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2012-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer
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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2012-03-07', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related Quality of life', 'timeFrame': 'Change in health related quality of life at 2 weeks. Change of Health Related Quality of Life at 4 weeks. Change in Health Related Quality of Life at 8 weeks. Change in Health Related Quality of Life at 12 weeks.', 'description': 'Health Related Quality of Life will be assessed using the SF-36, EQ-5D and QLQ30/13 questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Operable Early Stage NSCLC by the VATS Approach']}, 'descriptionModule': {'briefSummary': 'To test the effect of post operative complications on the health related quality of life (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer (NSCLC).\n\nThe HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery) using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications.\n\nPost operative complications will be assess while the patients in the hospital on a daily basis using the Clavien classification system for surgical complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with operable early stage NSCLC by the VATS approach who are referred to the Thoracic surgery Center in Edmonton, Alberta, Canada.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (more than 18 years)\n* early stage NSCLC\n* speak English\n* No hearing/Speaking difficulties\n* Able to walk without assistance\n* Surgery via the VATS approach\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Metastatic disease to the lung\n* Benign Lung disease\n* Advanced NSCLC\n* Small Cell Lung Cancer\n* Non English speakers\n* Walking/Hearing/Speaking difficulties'}, 'identificationModule': {'nctId': 'NCT01555502', 'briefTitle': 'Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'orgStudyIdInfo': {'id': 'HRQOL VATS lobectomy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low complications', 'description': 'Patients who had VATS lung resection for NSCLC, and have no or low grade (grade 1 and 2) post operative complications based on the Clavien classification system.'}, {'label': 'High complications', 'description': 'Patients who had VATS lung resection for NSCLC, and have no or high grade (grade 3 and 4) post operative complications based on the Clavien classification system.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}