Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses

What this Trial Is About

Researchers are evaluating whether a three-dimensional (3D)-printed external breast prosthesis can improve patient-reported outcomes for breast cancer patients who have had a mastectomy without undergoing surgical reconstruction. Breast cancer often requires mastectomy, and while reconstruction is common, some patients choose not to or are not candidates. Traditional external prostheses may lack comfort and proper fit, so this study is assessing a customized 3D-printed prosthesis made using 3D imaging and computer-aided design (CAD). This approach aims to create a better fitting prosthesis which could enhance patient satisfaction and emotional well-being. During the study, patients undergo a CT scan and have a patient-specific external breast prosthesis model developed using CAD. Measurements are taken for the 3D-printed prosthesis during screening. Participants then receive a fitting and are given the 3D-printed external breast prosthesis. The study involves procedures such as CAD development, measurements, prosthesis fitting, and receiving the customized prosthesis. Questionnaires are also administered to assess patient-reported outcomes. Participants will complete assessments at baseline and at 1, 3, 6, and 12 months, including surveys about satisfaction with appearance, emotional well-being, comfort, fit, and overall satisfaction with the 3D-printed prosthesis. Study procedures include surface scanning with temporary skin markers, standardized photography, and follow-up surveys. The study aims to monitor these outcomes over one year to evaluate the impact of the personalized prosthesis on patient experiences after mastectomy.

A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction