Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery
Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation
1 other identifier
interventional
88
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Aug 2021
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2021
CompletedStudy Start
First participant enrolled
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
September 10, 2025
September 1, 2025
4.9 years
August 23, 2021
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BREAST-Q Satisfaction
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.
4 weeks
Secondary Outcomes (1)
BREAST-Q Satisfaction
3 months after surgery
Study Arms (2)
Standard consultation with interactive 3D visualization
EXPERIMENTALParticipants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.
Standard consultation
ACTIVE COMPARATORParticipants in this group will receive a standard surgical consultation before their breast reconstruction procedure.
Interventions
The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
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.
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.
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
You may qualify if:
- ≥18 years old
- 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
You may not qualify if:
- Prior breast reconstruction
- Prior breast reconstruction consultation with a plastic surgeon
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carrie Stern, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 27, 2021
Study Start
August 23, 2021
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
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.