Use of an Interactive 3D Tool During Consultation for Breast Reconstruction Surgery

Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: interactive 3D tool; Other: BREAST-Q Reconstruction Module; Other: DQI; Other: Ottawa Decision Regret Scale

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• Prior breast reconstruction
• Prior breast reconstruction consultation with a plastic surgeon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: interactive 3D tool; The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.; Other: 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.; Other: 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.; Other: 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.
Active Comparator: Standard consultation; Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.	Other: 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BREAST-Q Satisfaction	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.	3 months after surgery

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Carrie Stern, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Consultation; Reconstruction Surgery; Interactive 3D Tool; 21-318
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 21-318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No