Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery
NCT ID: NCT05025020
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
88 participants
INTERVENTIONAL
2021-08-23
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard consultation with interactive 3D visualization
Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.
interactive 3D tool
The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
BREAST-Q Reconstruction Module
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.
DQI
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.
Ottawa Decision Regret Scale
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.
Standard consultation
Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.
BREAST-Q Reconstruction Module
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.
DQI
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.
Ottawa Decision Regret Scale
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.
Interventions
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interactive 3D tool
The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
BREAST-Q Reconstruction Module
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.
DQI
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.
Ottawa Decision Regret Scale
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.
Eligibility Criteria
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Inclusion Criteria
* Presenting at MSK for initial breast reconstruction consultation
* Planning to undergo mastectomy at time of consultation
* English spoken as primary language
* Able to provide informed consent without a legally authorized representative
Exclusion Criteria
* Prior breast reconstruction consultation with a plastic surgeon
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Carrie Stern, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-318
Identifier Type: -
Identifier Source: org_study_id
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