Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction
Breast Carcinoma
About this trial
This is an interventional health services research trial for Breast Carcinoma
Eligibility Criteria
Inclusion Criteria:
- MD Anderson patients, age 21 or older
- Planning to undergo either a unilateral or bilateral total, skin-sparing or nipple-sparing mastectomy; or, planning to undergo a unilateral or bilateral modified radical mastectomy
- Considering immediate breast reconstruction at MD Anderson
- Likely to be a suitable candidate for implant-based reconstruction and/or abdominal-tissue based reconstruction as determined by an MD Anderson Plastic Surgery faculty member
- Ambulatory and able to stand unassisted for two minutes (3D imaging system requirement)
- Ability to understand and read English without a translator
Exclusion Criteria:
- Has had a prior consultation with a plastic surgeon to discuss breast reconstruction
- History of breast surgery (i.e., breast reduction, mastopexy, segmental mastectomy, augmentation, reconstruction, but not including biopsy)
- Planning to have a delayed breast reconstruction
- Adjuvant radiation of the breast is indicated at the time of enrollment
- Diagnosis consistent with psychosis (such as schizophrenia, schizoaffective disorder, major depressive disorder [MDD] with psychotic features or steroid induced psychosis) in the chart
- Diagnosis consistent with cognitive impairment such as dementia, cognitive changes with stroke or radiation therapy in the chart
- Documented personality disorder
- Presence of non-medical tattoo on the breast
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (educational materials, enhanced consult, decision aid)
Arm II (educational materials, standard of care consultation)
Patients receive newly-developed educational materials about breast reconstruction and attend an enhanced consultation visit with their plastic surgeon to discuss options for breast reconstruction surgery, during which a decision aid application containing a customized presentation of possible breast reconstruction outcomes is presented. At the end of the consultation visit, patients complete questionnaires about decision-making and psychological well-being. Within 4-6 weeks and 3-6 months after beginning the reconstruction process, patients also complete questionnaires about satisfaction with their breasts, body image, and psychological well-being, and undergo two-dimensional (2D) and 3D imaging of the torso.
Patients receive newly-developed educational materials about breast reconstruction and attend a standard of care consultation visit with their plastic surgeon to discuss options for breast reconstruction surgery. At the end of the consultation visit, patients complete questionnaires about decision-making and psychological well-being. Within 4-6 weeks and 3-6 months after beginning the reconstruction process, patients also complete questionnaires about satisfaction with their breasts, body image, and psychological well-being, and undergo 2D and 3D imaging of the torso.