Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-12 @ 11:56 AM
Study NCT ID:
NCT02882750
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2016-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect on Patient Reported Outcomes of VATS and SABR (LILAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-02', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients Reported Outcomes', 'timeFrame': '12 months', 'description': 'Quality of life (EORTC QLQ-C30 and LC13 questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Decision self-efficacy scale', 'timeFrame': '3 months', 'description': 'Patient perspectives of the Shared Decision Making Process.'}, {'measure': 'Patient Acceptability', 'timeFrame': '12 months', 'description': 'Patient acceptability explored through interviews'}, {'measure': 'Clinician Acceptability', 'timeFrame': '12 months', 'description': 'clinician acceptability explored through interviews'}, {'measure': 'Patients satisfaction', 'timeFrame': '1 month', 'description': 'patients satisfaction of the care received (PSQ-18 Patient satisfaction questionnaire)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'Quality of Life', 'VATS', 'SABR'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '28932579', 'type': 'DERIVED', 'citation': 'Pompili C, Franks KN, Brunelli A, Hussain YS, Holch P, Callister ME, Robson JM, Papagiannopoulos K, Velikova G. Patient reported outcomes following video assisted thoracoscopic (VATS) resection or stereotactic ablative body radiotherapy (SABR) for treatment of non-small cell lung cancer: protocol for an observational pilot study (LiLAC). J Thorac Dis. 2017 Aug;9(8):2703-2713. doi: 10.21037/jtd.2017.07.35.'}]}, 'descriptionModule': {'briefSummary': 'This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with this information the Shared Decision Making (SDM) process.\n\n300 consecutive patients will be followed up from prior the treatment to 12 months afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18, Decision Self-Efficacy Scale) by a remote web-based system.\n\nDeliverable:\n\n1. Differences after VATS resections or SABR in terms of physical and psychological symptoms, quality of life and satisfaction\n2. Patient perspectives of the Shared Decision Making Process.', 'detailedDescription': "1. Methods\n\n Aim and Objectives\n\n This study aims to describe the trajectory of lung cancer patients HRQoL, symptoms and functions following VATS or SABR treatment for Stage I-II NSCLC and to determine the feasibility and patient acceptability of online self-reporting of PROMs.\n\n Specific objectives of the study include:\n * To compare changes before and after treatment of patient reported outcomes (HRQOL and Patient Satisfaction) after VATS lung resections or SABR in early stage lung cancer patients.\n * To correlate clinical outcomes (complications and AEs) with Quality of Life in order to find objective predictors of major decline in patient reported outcomes.\n * To identify specific factors, which have influenced the personal choice between the treatments (Decision Self-Efficacy Scale)\n * Establish recruitment and attrition rates and adherence to PROMs reporting during the study\n * To describe patient choice of electronic vs paper questionnaires\n * To explore implementation issues through patient and staff interview.\n2. Design\n\nThis is an observational prospective longitudinal study with repeated measures (PROMs), employing a convenience sample of consecutive patients planned to have VATS resections or SABR for stages I-II of NSCLC. Outcomes measures will be collected prior to treatment and 1,3,6,12 months afterwards, administering the questionnaires by the remote web-based system. Paper administration will be offered to patients without Internet access.\n\nSample size considerations\n\nLast year 100 pre-surgical quality of life questionnaires have been collected in 5 months from outpatients' clinic at Leeds Cancer Centre (LCC). For longitudinal studies involving regular PROMs, the investigators typically see 70% consent rate and 30-35% attrition over 3 months24. Therefore the investigators expectations are to be able to recruit 200 VATS and 50 SABR patients recruiting over 12 months with 12 months of follow-up.\n\nIn order to detect a minimum difference of 10% from the baseline value and standard deviation of the EORTC QLQ-C30 Global Health Scale scale (as measured in our historical cohort of 115 anatomic lung resections), with a alfa level of 0.05 and statistical power of 90%, a sample size of 115 patients in the surgical arm was estimated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Early stage Non-Small Cell Lung Cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and over.\n* Diagnosis of NSCLC either from histology or MDT/Tumour Board agreement on \\>95% likelihood of diagnosis based on radiological evidence or both.\n* Decision for either surgery or SABR\n* Able to give informed consent.\n* Able to understand the language of the questionnaire.\n* There will be no limit on performance status.\n\nExclusion Criteria:\n\n* Advanced diseases (III-IV stages).\n* Patient included in other HRQoL study, which may increase patient burden and bias the answer of the questionnaires.'}, 'identificationModule': {'nctId': 'NCT02882750', 'acronym': 'LILAC', 'briefTitle': 'Effect on Patient Reported Outcomes of VATS and SABR (LILAC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Curative Treatment Modalities of Early Stages Non-Small Cell Lung Cancer: Effect on Patient Reported Outcomes of Video Assisted Thoracoscopic (VATS) Resection and Stereotactic Ablative Body Radiotherapy (SABR)', 'orgStudyIdInfo': {'id': 'L399'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical Patients', 'description': 'Early stage NSCLC patients submitted to Surgical Resection', 'interventionNames': ['Other: EORTC QLQ-C30 (version 3.0).', 'Other: PS Q18', 'Other: Decision Self-Efficacy Scale']}, {'label': 'SABR Patients', 'description': 'Early stage NSCLC patients submitted to SABR', 'interventionNames': ['Other: EORTC QLQ-C30 (version 3.0).', 'Other: PS Q18', 'Other: Decision Self-Efficacy Scale']}], 'interventions': [{'name': 'EORTC QLQ-C30 (version 3.0).', 'type': 'OTHER', 'description': 'Quality of Life Questionnaire', 'armGroupLabels': ['SABR Patients', 'Surgical Patients']}, {'name': 'PS Q18', 'type': 'OTHER', 'description': 'Patients Satisfaction Questionnaire', 'armGroupLabels': ['SABR Patients', 'Surgical Patients']}, {'name': 'Decision Self-Efficacy Scale', 'type': 'OTHER', 'description': 'Questionnaire', 'armGroupLabels': ['SABR Patients', 'Surgical Patients']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yorkshire Cancer Research', 'class': 'OTHER'}, {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof of Clinical Oncology', 'investigatorFullName': 'Galina Velikova', 'investigatorAffiliation': 'University of Leeds'}}}}