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.
Adult individuals aged 18 years or older
History of unilateral or bilateral mastectomy for any indication
No implant or autologous reconstruction
Allowed: Goldilocks closure, flat closure, simple skin closure
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)
Patients with open wounds, active infection, or dermatologic conditions at the chest/breast site that would interfere with scanning, fiducial marker placement, or prosthesis use
Single group
Computer-Aided Diagnosis
Procedure/SurgeryUndergo CAD development for patient-specific external breast prosthesis model
Prosthetics Intervention
Procedure/SurgeryUndergo measurements for external breast prosthesis
Prosthetics Intervention
Procedure/SurgeryUndergo fitting for 3D-printed external breast prosthesis
Prosthetics Intervention
Procedure/SurgeryReceive 3D-printed external breast prosthesis
Questionnaire Administration
Other interventionAncillary studies
Patient-reported satisfaction with appearance
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Patient-reported emotional well-being
Will be assessed by a an Emotional Response survey, which consists of 12 questions answered on a five-point Likert scale ranging from strongly disagree to strongly agree.
Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Patient-reported fit of personalized 3D-printed breast prosthesis
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Patient-reported satisfaction with personalized 3D-printed breast prosthesis
Will be assessed by a Prostheses Evaluation survey, which consists of 11 questions answered on a five-point Likert scale ranging from very dissatisfied to very satisfied.
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