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

NCT ID: NCT05025020

Last Updated: 2025-09-10

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

interactive 3D tool

Intervention Type OTHER

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

BREAST-Q Reconstruction Module

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Standard consultation

Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.

Group Type ACTIVE_COMPARATOR

BREAST-Q Reconstruction Module

Intervention Type 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

Intervention Type 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

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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21-318

Identifier Type: -

Identifier Source: org_study_id

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