Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-25 @ 3:02 PM
Study NCT ID:
NCT04783168
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clavien-Dindo postoperative morbidity (POM) score', 'timeFrame': 'Up to 30 days after surgery', 'description': "Two Bayesian probability and inferential models will be utilized:\n\n* Model 1: Inferential goals: Probability that POM score in the control arm is greater than F0 or FB arm: mean and 95% Credible Interval\n* Model 2: Baseline covariates adjusted analysis of model 1\n\n * Performance status\n * FEV1\n * Age\n * Open vs. Minimally invasive (0 is best, 5 is worst.) 0 - No postoperative complications 1. - Minor complication resolved without intervention 2. - complication requiring pharmaceutical intervention 3. - complication requiring surgical, endoscopic or radiological intervention, 4. - life-threatening complication requiring intensive care 5. - complication leading to the patient's death."}], 'secondaryOutcomes': [{'measure': 'Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Number of steps regained starting from after surgery for each of the arms.'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline to 30 days after surgery', 'description': 'Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Up to 30 days after surgery'}, {'measure': 'Hospital readmission rate for lung surgery related events', 'timeFrame': 'Up to 30 days after surgery'}, {'measure': 'Return of bowel function', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Time to first bowel movement.'}, {'measure': 'Postoperative complications and step numbers', 'timeFrame': 'Up to 30 days after surgery', 'description': 'How would you rate daily step goals as being helpful in your postoperative recovery? From 0-5, 0 being not helpful at all and 5 being the most helpful.'}, {'measure': 'Fitbit user experience (F0 and FB arm)', 'timeFrame': 'Up to 30 days after surgery', 'description': 'Survey. How would you rate the use of Fitbit in your postoperative recovery From 0-5, 0 being not helpful at all and 5 being the most helpful How difficult was it to keep the device on your wrist From 0-5, 0 being extremely difficult, and 5 being extremely easy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearable', 'device', 'fitness', 'tracker', 'Fitbit', 'ambulation', 'lung cancer', 'surgical', 'recovery'], 'conditions': ['Lung Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluates the relationship between walking and sleeping habits and surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased or less severe complications. Learning about how much patients walk may be important in improving outcomes after surgery. Information gained from this trial may help researchers develop interventions to improve outcomes after surgery and improve overall quality of life after surgery in patients with lung cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Estimate the difference between each Fitbit arm and a control arm in Clavien-Dindo Combined Postoperative Morbidity (POM) Score in the 30-day postoperative period.\n\nSECONDARY OBJECTIVES:\n\nI. For patients in Fitbit only arm (F0) and Fitbit integration arm (FB), evaluate the differences in steps regained at each postoperative day.\n\nII. Quality of life before and after surgery using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC).\n\nIII. Hospital length of stay. IV. Hospital readmission rate within 30 days for lung surgery related events. V. Return of bowel function. VI. Postoperative complications and step numbers. VII. Fitbit user experience in the FB arm.\n\nEXPLORATORY OBJECTIVES:\n\nI. Sleep disturbances. II. Cost analysis.\n\nOUTLINE: Patients are randomized to 1 of 3 arms.\n\nARM I: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.\n\nARM II: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count.\n\nARM III: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR\\^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.\n\nAfter completion of study intervention, patients are followed up at postoperative clinic and at 30 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* English speaking\n* Ambulatory preoperatively\n* Patients undergoing at least a lobectomy\n* Must own a smart phone and be willing to install the Fitbit application (App)\n* Adequate internet connection via wifi or wireless network connection with smartphone\n* Patients who are not already using a wearable device to track daily steps\n\nExclusion Criteria:\n\n* Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.\n* Cannot maintain activity monitor in place at the time of consent\n* Pregnant patients"}, 'identificationModule': {'nctId': 'NCT04783168', 'acronym': 'AIRTECH', 'briefTitle': 'Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study', 'orgStudyIdInfo': {'id': '2020-0453'}, 'secondaryIdInfos': [{'id': 'NCI-2020-14126', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2020-0453', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (usual care)', 'description': 'Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.', 'interventionNames': ['Other: Best Practice', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (usual care, Fitbit)', 'description': 'Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count', 'interventionNames': ['Other: Best Practice', 'Other: Medical Device Usage and Evaluation', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (usual care, Fitbit, Fitbit app)', 'description': 'Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR\\^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.', 'interventionNames': ['Other: Best Practice', 'Other: Health Promotion and Education', 'Other: Medical Device Usage and Evaluation', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive usual care', 'armGroupLabels': ['Arm I (usual care)', 'Arm II (usual care, Fitbit)', 'Arm III (usual care, Fitbit, Fitbit app)']}, {'name': 'Health Promotion and Education', 'type': 'OTHER', 'description': 'Install and use Fitbit app', 'armGroupLabels': ['Arm III (usual care, Fitbit, Fitbit app)']}, {'name': 'Medical Device Usage and Evaluation', 'type': 'OTHER', 'description': 'Use Fitbit to monitor step count', 'armGroupLabels': ['Arm II (usual care, Fitbit)', 'Arm III (usual care, Fitbit, Fitbit app)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care)', 'Arm II (usual care, Fitbit)', 'Arm III (usual care, Fitbit, Fitbit app)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care)', 'Arm II (usual care, Fitbit)', 'Arm III (usual care, Fitbit, Fitbit app)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Garrett L. Walsh', 'role': 'CONTACT', 'phone': '713-792-6849'}, {'name': 'Garrett L. Walsh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Garrett L Walsh', 'role': 'CONTACT', 'email': 'gwalsh@mdanderson.org', 'phone': '713-792-6849'}], 'overallOfficials': [{'name': 'Garrett L Walsh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}