Patient-Specific Decision Aid System for Shared Decision Making About Breast Reconstruction

PRIMARY OBJECTIVE:

I. To evaluate a newly-developed computer application designed to facilitate shared decision making about breast reconstruction for practicability and usability.

SECONDARY OBJECTIVES:

I. To evaluate the effect of the decision aid application measured as the patient's decisional conflict, decision regret, and psychosocial well-being.

II. To evaluate the accuracy of predicted breast reconstruction outcomes to enhance the mathematical and physics-based algorithms for future use.

EXPLORATORY OBJECTIVE:

I. To evaluate patients' aesthetic measures, such as symmetry, breast volume, breast contour and ptosis 3 months after surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

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