Overview
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is customized to the patient using 3D imaging along with computer-aided design (CAD) to interpret the 3D imaging to develop and print a patient-specific external breast prosthesis. This may create a better fitting prosthesis which may improve PRO.
Eligibility
Inclusion Criteria:
- Adult individuals aged 18 years or older
- Have undergone mastectomy for breast cancer treatment without subsequent breast reconstruction
- Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
- Ability to provide informed consent
Exclusion Criteria:
- Individuals with contraindications for participation, such as severe medical conditions that may interfere with study procedures
- Lack of willingness or capacity to provide informed consent for study participation
- Inability to communicate effectively in the study language (e.g., English)