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

Breast Cancer Clinical Trial

Official title:

Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05025020
• Other study ID #: 21-318
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• interactive 3D tool
The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan Kettering Cancer Center