Breast Cancer
Conditions
Keywords
Reconstruction Surgery, Interactive 3D Tool, Consultation, 21-318
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.
Interventions
OTHERinteractive 3D tool
The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
OTHERBREAST-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.
OTHERDQI
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.
OTHEROttawa 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarrie Stern, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed