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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05025020
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-23
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BREAST-Q Satisfaction	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 Outcome Measures

Name	Time	Method
BREAST-Q Satisfaction	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States