Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT03689634
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Move For Surgery - A Novel Preconditioning Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome of the comparative trial will be length of stay (LOS) in hospital after surgery, which will also be used to measure speed of recovery from surgery and postoperative complications.', 'timeFrame': '24 months', 'description': 'LOS is a good surrogate measure for the speed of recovery from surgery (patients who recover faster leave hospital earlier) and postoperative complications (patients who do not suffer complications leave the hospital earlier).'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome will include differences in the 36-Item Short Form Health Survey (SF-36) scores before and after the intervention.', 'timeFrame': '24 months', 'description': 'The quality of life as reported by patients will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer, Nonsmall Cell']}, 'referencesModule': {'references': [{'pmid': '37643916', 'type': 'DERIVED', 'citation': 'Patel YS, Sullivan KA, Churchill IF, Beauchamp MK, Wald J, Mbuagbaw L, Fahim C, Hanna WC. Preconditioning program reduces the incidence of prolonged hospital stay after lung cancer surgery: Results from the Move For Surgery randomized clinical trial. Br J Surg. 2023 Oct 10;110(11):1467-1472. doi: 10.1093/bjs/znad252.'}]}, 'descriptionModule': {'briefSummary': 'Lung cancer is the leading cause of cancer death in Canada. Most patients with this cancer will undergo treatment with major chest surgery that is associated with serious complications. As many as 50% of patients will suffer respiratory complications after surgery, keeping them in the hospital for extended periods of time. These long hospitalizations have a dramatic negative effect on the lives of those people, in addition to a large cost burden on our healthcare system. Traditionally, patients who suffer from complications are treated with rehabilitation AFTER the complications have occurred. But what if complications can be prevented BEFORE they happen? Having major chest surgery imposes great stress on the human body, one that is equivalent to running a marathon. Analogous to training before completing a marathon, the investigator designed Move For Surgery (MFS), a novel preconditioning program that encourages and empowers patients to improve their health prior to surgery. The investigator aims to demonstrate that patients who train with Move For Surgery will have lower respiratory complication rates, will recover better, and will leave the hospital sooner than their counterparts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical stage I, II, or IIIa non-small cell lung cancer (NSCLC)\n* Candidates for thoracic surgery, as determined by the operating surgeon\n\nExclusion Criteria:\n\n* Clinical stage IIIb or IV NSCLC\n* Patients with affected mobility (wheelchair, walker)\n* Patients who use oxygen at home'}, 'identificationModule': {'nctId': 'NCT03689634', 'acronym': 'MFS', 'briefTitle': 'Move For Surgery - A Novel Preconditioning Program', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'Move For Surgery - A Novel Preconditioning Program to Optimize Health Before Thoracic Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SJHH-MFS-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Move For Surgery Preconditioning Program Intervention Group', 'interventionNames': ['Device: Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Preoperative Care Group'}], 'interventions': [{'name': 'Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group', 'type': 'DEVICE', 'description': 'Participants randomized to this group will be be provided with a wearable activity tracker (Fitbit) for the duration of the study and asked to reach daily step goals.', 'armGroupLabels': ['Move For Surgery Preconditioning Program Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Academic Health Sciences Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Wael Hanna', 'investigatorAffiliation': 'McMaster University'}}}}