Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT03234933
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2017-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Operative Ambulatory Challenge and Exercise (PACE) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Steps Taken', 'timeFrame': '2 years', 'description': 'Number of steps taken by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.'}], 'secondaryOutcomes': [{'measure': 'Distance walked', 'timeFrame': '2 years', 'description': 'The distance walked by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.'}, {'measure': 'Number of Calories Burned', 'timeFrame': '2 years', 'description': 'The number of calories burned by subjects will be recorded on a mobility tracker, starting at the time of admission to the floor and ending at the time of discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This research study is evaluating the postoperative results in terms of quality of life and functional recovery of elderly patients after cancer surgery.', 'detailedDescription': 'This is a pilot study, designed to collect data on steps walked (ambulation) per day of lobectomy patients after surgery. While the investigators know ambulation improves outcomes after surgery, there is no institutional policy, set of patient goals, or method for deciding which patients require further resources, such as physical therapy. Data collected will be used to set up a hospital-wide strategy for patients to achieve post-operative ambulation milestones more readily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients Aged ≥ 18 years\n* Who underwent or who will undergo lung resection at Brigham and Women's Hospital (BWH)\n* With diagnosis of malignant or benign disease\n\nExclusion Criteria:\n\n* Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)\n* Patients with cognitive deficits"}, 'identificationModule': {'nctId': 'NCT03234933', 'briefTitle': 'Post-Operative Ambulatory Challenge and Exercise (PACE) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Post-Operative Ambulatory Challenge and Exercise (PACE) Trial', 'orgStudyIdInfo': {'id': '17-152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobility Tracker', 'description': '* Each patient will be provided by the research team staff with a new mobility tracker\n* The standard pre-operative assessment, surgical procedure and post-operative care will still be done\n* Measurements of each patient (steps, distance and calories) will be obtained by the research staff', 'interventionNames': ['Other: Mobility Tracker']}], 'interventions': [{'name': 'Mobility Tracker', 'type': 'OTHER', 'description': "Tracking Patient's movements and calories", 'armGroupLabels': ['Mobility Tracker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael T Jaklitsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Michael Jaklitsch, MD', 'investigatorFullName': 'Michael T. Jaklitsch', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}