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

Study Overview
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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.

Official Title
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Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: interactive 3D tool
* Other: BREAST-Q Reconstruction Module
* Other: DQI
* Other: Ottawa Decision Regret Scale


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard consultation with interactive 3D visualization<br>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<br>* The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.<br>Other: BREAST-Q Reconstruction Module<br>* 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.<br>Other: DQI<br>* 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.<br>Other: Ottawa Decision Regret Scale<br>* 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.<br>|
| Active Comparator: Standard consultation<br>Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure. | Other: BREAST-Q Reconstruction Module<br>* 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.<br>Other: DQI<br>* 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.<br>Other: Ottawa Decision Regret Scale<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reconstruction Surgery, Interactive 3D Tool, Consultation, 21-318