NCT05130580

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates whether a decision aid application (app) is effective in helping breast reconstruction surgery patients make informed decisions about breast reconstruction surgery. Researchers have created a computer app for breast reconstruction surgery patients that presents images of breast reconstruction outcomes that are customized to the individual patient's treatment options and personal preferences. This decision aid app may help educate patients about how they might look after surgery and answer their questions.

Detailed description

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Enhanced Consultation	Attend an enhanced consultation with decision aid
OTHER	Standard of Care Consultation	Attend standard of care consultation
PROCEDURE	Conventional Imaging	Undergo 2D and 3D torso imaging
OTHER	Educational Intervention	Receive educational materials
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-10-13
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-11-23
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States