Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05025020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2021-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BREAST-Q Satisfaction', 'timeFrame': '4 weeks', 'description': 'scores at 4 weeks (T2) Scores for each domain of the BREAST-Q range from 0 to 100, implying a continuum of increasing satisfaction or better quality of life.'}], 'secondaryOutcomes': [{'measure': 'BREAST-Q Satisfaction', 'timeFrame': '3 months after surgery', 'description': 'The outcome will be the score (continuous variable ranging from 0 to 100 for linear regression or ordinal categories, ranging from 1 to 4 for ordinallogistic regression, where 1 represents lowest satisfaction and 4 represents highest satisfaction), and the primary predictor of interest will be type of consultation provided.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reconstruction Surgery', 'Interactive 3D Tool', 'Consultation', '21-318'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether using an interactive 3D tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. The study researchers will also assess whether women whose surgical consultation includes the use of the 3D tool are more satisfied with their breasts and with the decisions they made about their reconstruction procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* Presenting at MSK for initial breast reconstruction consultation\n* Planning to undergo mastectomy at time of consultation\n* English spoken as primary language\n* Able to provide informed consent without a legally authorized representative\n\nExclusion Criteria:\n\n* Prior breast reconstruction\n* Prior breast reconstruction consultation with a plastic surgeon'}, 'identificationModule': {'nctId': 'NCT05025020', 'briefTitle': 'Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation', 'orgStudyIdInfo': {'id': '21-318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard consultation with interactive 3D visualization', 'description': 'Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.', 'interventionNames': ['Other: interactive 3D tool', 'Other: BREAST-Q Reconstruction Module', 'Other: DQI', 'Other: Ottawa Decision Regret Scale']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard consultation', 'description': 'Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.', 'interventionNames': ['Other: BREAST-Q Reconstruction Module', 'Other: DQI', 'Other: Ottawa Decision Regret Scale']}], 'interventions': [{'name': 'interactive 3D tool', 'type': 'OTHER', 'description': 'The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.', 'armGroupLabels': ['Standard consultation with interactive 3D visualization']}, {'name': 'BREAST-Q Reconstruction Module', 'type': 'OTHER', 'description': 'The BREAST-Q Reconstruction Module1-3 has 6 domains that cover various aspects of patient satisfaction and quality of life. BREAST-Q is part of our standard of care for patients treated for breast cancer and referred for reconstruction.', 'armGroupLabels': ['Standard consultation', 'Standard consultation with interactive 3D visualization']}, {'name': 'DQI', 'type': 'OTHER', 'description': 'The DQI has 3 domains that cover decision-specific questions about what it is like for a patient to make decisions about reconstruction after breast cancer treatment.', 'armGroupLabels': ['Standard consultation', 'Standard consultation with interactive 3D visualization']}, {'name': 'Ottawa Decision Regret Scale', 'type': 'OTHER', 'description': 'The validated Decision Regret Scale measures distress or remorse after a health care decision by the use of 5 items to indicate the extent to which the respondent agrees or disagrees with the statements in the regret scale.', 'armGroupLabels': ['Standard consultation', 'Standard consultation with interactive 3D visualization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Carrie Stern, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'url': 'http://www.mskcc.org', 'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}