Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:51 PM
Study NCT ID:
NCT06625008
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2024-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative 3D Models and Shared Decision-making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking was not performed as it was not feasible'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shared decision making', 'timeFrame': 'Within 30 minutes after the preoperative counselling session.', 'description': 'Quantify and compare patient perception of involvement in decision-making in either arm, measured by the validated Shared Decision Making (SDM-Q9) tool.'}], 'secondaryOutcomes': [{'measure': 'Change in patient anxiety', 'timeFrame': 'Within 30 minutes before and 30 minutes after the preoperative counselling session.', 'description': 'Quantify and compare patient anxiety levels before and after the pre-operative consent, measured by the validated State-Trait Anxiety Inventory (STAI-6) among the study arms.'}, {'measure': 'Change in patient knowledge using a self-developed questionnaire', 'timeFrame': 'Within 30 minutes before and 30 minutes after the preoperative counselling session.', 'description': 'Using a self-developed questionnaire to quantify and compare patient knowledge of the essential aspects of anatomy, disease, and surgical procedure covered in preoperative counseling to understand how patient knowledge improves with counseling and compares between the study arms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', '3D Model', 'Shared Decision Making', 'Preoperative anxiety', 'Patient knowledge', 'Informed Consent'], 'conditions': ['Colorectal Cancer', 'Shared Decision Making', 'Anxiety', 'Informed Consent']}, 'referencesModule': {'references': [{'pmid': '40459895', 'type': 'DERIVED', 'citation': 'Khan A, Sellyn GE, Ali D, Moazzam Z, Samaras H, McChesney SL, Hopkins MB, Ford MM, Muldoon RL, Geiger TM, Martin D, Chu DI, VanKoevering KK, Hawkins AT. Three-Dimensional-Printed Models and Shared Decision-Making: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513187. doi: 10.1001/jamanetworkopen.2025.13187.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.', 'detailedDescription': 'In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be \\>18 years\n* Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum\n\nExclusion Criteria:\n\n* Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum'}, 'identificationModule': {'nctId': 'NCT06625008', 'briefTitle': 'Preoperative 3D Models and Shared Decision-making', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Impact of 3D-Printed Model on Shared Decision-Making and Anxiety in Patients Undergoing Surgery: the SEAD Pilot Randomized Trial', 'orgStudyIdInfo': {'id': '211314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D-printed model arm', 'description': 'Surgeons in this arm will use a 3D-printed modular human torso model with a magnetically detachable colon and rectum to teach patients about the anatomy and proximity of colonic segments undergoing surgery, potential surgical complications, and operative procedures during the pre-operative consent.', 'interventionNames': ['Other: 3D-printed model']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care arm', 'description': 'Surgeons will employ the usual pre-operative counseling in this arm. This will include teaching patients about the anatomy, operative procedures, and potential surgical complications during the pre-operative consent using 2D images.'}], 'interventions': [{'name': '3D-printed model', 'type': 'OTHER', 'description': 'The Department of Radiology at Vanderbilt University Medical Center will create a 3D-printed human torso model that includes the colon, rectum, and a stoma on the abdominal wall. This model will be used to provide pre-operative counseling during the surgical consent for patients.', 'armGroupLabels': ['3D-printed model arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Aimal Khan', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}