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NCT Number: NCT05025020

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interactive 3D tool

Other

The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.

BREAST-Q Reconstruction Module

Other

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

Other

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

Other

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.

Primary outcomes

  1. BREAST-Q Satisfaction

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. BREAST-Q Satisfaction

    Time frame: 3 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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