Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT07062393
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2025-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study employs a 2-period, 2-sequence crossover design in which all participants receive both interventions (traditional counseling and mobile augmented reality \\[MAR\\] counseling) in different sequences. Participants are randomly assigned to either the traditional-then-MAR group (T-M group) or the MAR-then-traditional group (M-T group). This design allows within-subject comparison of counseling effectiveness, minimizing individual variability.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shared decision-making score', 'timeFrame': 'Immediately after counseling session (single timepoint)', 'description': 'Shared decision-making was evaluated using a validated questionnaire assessing patient perceptions of decision support, preparedness, and engagement. The total score ranges from 0 to 50, with higher scores indicating better shared decision-making.'}], 'secondaryOutcomes': [{'measure': 'Patient counseling preference', 'timeFrame': 'Immediately after both counseling sessions', 'description': 'Participants indicated their preference for either traditional counseling or MAR-based counseling after experiencing both, using a structured post-intervention questionnaire. The results were reported as percentages per group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shared decision making', 'Patient education', 'Augmented reality'], 'conditions': ['Lung Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '36818764', 'type': 'BACKGROUND', 'citation': 'McDonald M, Shirk JD. The Effect of Digital Three-Dimensional Reality Models on Patient Counseling for Renal Masses. JSLS. 2023 Jan-Mar;27(1):e2022.00084. doi: 10.4293/JSLS.2022.00084.'}, {'pmid': '34542639', 'type': 'BACKGROUND', 'citation': 'Arjomandi Rad A, Vardanyan R, Thavarajasingam SG, Zubarevich A, Van den Eynde J, Sa MPBO, Zhigalov K, Sardiari Nia P, Ruhparwar A, Weymann A. Extended, virtual and augmented reality in thoracic surgery: a systematic review. Interact Cardiovasc Thorac Surg. 2022 Jan 18;34(2):201-211. doi: 10.1093/icvts/ivab241.'}, {'pmid': '8678709', 'type': 'BACKGROUND', 'citation': 'Deber RB, Kraetschmer N, Irvine J. What role do patients wish to play in treatment decision making? Arch Intern Med. 1996 Jul 8;156(13):1414-20.'}, {'pmid': '9192250', 'type': 'BACKGROUND', 'citation': 'Braddock CH 3rd, Fihn SD, Levinson W, Jonsen AR, Pearlman RA. How doctors and patients discuss routine clinical decisions. Informed decision making in the outpatient setting. J Gen Intern Med. 1997 Jun;12(6):339-45. doi: 10.1046/j.1525-1497.1997.00057.x.'}, {'pmid': '12724430', 'type': 'BACKGROUND', 'citation': "Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available."}, {'pmid': '24436529', 'type': 'BACKGROUND', 'citation': 'Lackey A, Donington JS. Surgical management of lung cancer. Semin Intervent Radiol. 2013 Jun;30(2):133-40. doi: 10.1055/s-0033-1342954.'}, {'pmid': '31912902', 'type': 'BACKGROUND', 'citation': 'Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.'}, {'pmid': '41069141', 'type': 'DERIVED', 'citation': 'Chen YS, Hsu YC, Romalee W, Wang DH, Lai J, Huang TW, Lin KH. Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: Randomized Clinical Crossover Trial. JMIR Mhealth Uhealth. 2025 Nov 13;13:e79632. doi: 10.2196/79632.'}]}, 'descriptionModule': {'briefSummary': "This randomized clinical trial evaluates the effectiveness of Mobile Augmented Reality (MAR) counseling compared to traditional verbal counseling for patients undergoing thoracic surgery. MAR counseling integrates patient-specific 3D anatomical models to enhance understanding of surgical procedures and risks. The study assesses patient and caregiver satisfaction, decision-making confidence, and communication quality. Health care providers' perspectives on the counseling methods are also examined. Participants will be assigned to one of the two counseling groups and asked to complete a questionnaire immediately after the counseling session."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 20 years and older\n* Scheduled for elective thoracic surgery\n* Able to understand written and spoken Mandarin\n* Willing and able to provide informed consent\n* Capable of completing questionnaires independently or with minimal assistance\n\nExclusion Criteria:\n\n* Emergency surgery cases\n* Severe cognitive impairment or psychiatric illness interfering with participation\n* Visual or hearing impairments that prevent interaction with mobile devices\n* Previous participation in a similar counseling trial\n* Inability to complete follow-up procedures'}, 'identificationModule': {'nctId': 'NCT07062393', 'briefTitle': 'Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Effect of Mobile Augmented Reality Counseling on Improving Shared Decision-Making in Thoracic Surgery: A Randomized Clinical Controlled Trial', 'orgStudyIdInfo': {'id': 'TSGH-MAR-SDM-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traditional First, Then MAR Counseling (T-M group)', 'description': 'Participants receive traditional counseling first, followed by MAR counseling using a 3D mobile application.', 'interventionNames': ['Behavioral: Traditional Counseling → MAR Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'MAR First, Then Traditional Counseling (M-T group)', 'description': 'Participants receive MAR counseling first using a mobile 3D model app, followed by traditional counseling with CT images and verbal explanations.', 'interventionNames': ['Behavioral: MAR Counseling → Traditional Counseling']}], 'interventions': [{'name': 'Traditional Counseling → MAR Counseling', 'type': 'BEHAVIORAL', 'description': 'A single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images.', 'armGroupLabels': ['Traditional First, Then MAR Counseling (T-M group)']}, {'name': 'MAR Counseling → Traditional Counseling', 'type': 'BEHAVIORAL', 'description': 'A single session begins with mobile augmented-reality counseling using interactive 3D models, followed by a standard verbal counseling with printed diagrams and CT images.', 'armGroupLabels': ['MAR First, Then Traditional Counseling (M-T group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114202', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Kuan-Hsun Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital, National Defense Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data (IPD) will not be shared due to ethical considerations and institutional policy. The informed consent obtained from participants does not include provisions for public data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Chen Ying-Shian', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}