Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 10:26 PM
Study NCT ID:
NCT05363150
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2022-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Smart Device Application for Home-based Prehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance of a smartphone application', 'timeFrame': 'A day before surgery at ward', 'description': 'Based on the data saved in the application, when the program started and ended, how many steps and distance the patient exercised per day, how many sets patient did muscle exercise per day and week will be collected to calculate the compliance.'}, {'measure': 'Satisfaction of a smartphone application', 'timeFrame': 'A day before surgery at ward', 'description': 'Using the questionnaire that we made to evaluation the satisfaction of a smartphone application.'}], 'secondaryOutcomes': [{'measure': 'Korean-EORTC QLQ C-30', 'timeFrame': '4 weeks before the surgery at clinic, a day before the surgery at ward', 'description': 'EORTC QLQ C-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core-30\n\nA questionnaire which is designed to assess the different aspects that define the QoL of cancer patients. (Total score ranging 0 to 100, A high score for a functional scale represents a high level of functioning)'}, {'measure': '6-minute walk test', 'timeFrame': '4 weeks before the surgery at clinic, a day before the surgery at ward', 'description': 'The distance that patient can walk during 6 minutes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer patient', 'Cancer Surgery', 'Prehabilitation'], 'conditions': ['Cancer', 'Prehabilitation']}, 'descriptionModule': {'briefSummary': 'To investigate the feasibility of a home-based exercise training program using a smartphone application in patients planning for cancer surgery, and to determine the effectiveness of this application on functional capacity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who visits preoperative evaluation clinic for preoperative counseling before the cancer surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (19-70) who are scheduled for elective cancer surgery\n* American Society of Anesthesiologists (ASA) physical status classification I or II\n* Patients who can use a smartphone application\n* Patients who can perform an exercise program for at least 3 weeks from the first visit to the preoperative clinic to elective surgery\n\nExclusion Criteria:\n\n* Patients who are unable to communicate\n* Patients under the age of 19 and over 70\n* Patients who have a major medical or psychiatric disorder that is expected to affect exercise\n* Patients with contraindications to the general rehabilitation program'}, 'identificationModule': {'nctId': 'NCT05363150', 'briefTitle': 'Feasibility of a Smart Device Application for Home-based Prehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Feasibility of a Smart Device Application for Home-based Prehabilitation in Patients Undergoing Lung Cancer Surgery: A Prospective Observational Pilot Study', 'orgStudyIdInfo': {'id': 'Prehab_app'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Susie Yoon, PhD', 'role': 'CONTACT', 'email': 'susiey87@gmail.com', 'phone': '+82-2-2072-1860'}], 'overallOfficials': [{'name': 'Susie Yoon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Susie Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}