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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Undergo CAD development for patient-specific external breast prosthesis model
Undergo measurements for external breast prosthesis
Undergo fitting for 3D-printed external breast prosthesis
Receive 3D-printed external breast prosthesis
Ancillary studies
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGPatient-reported satisfaction with appearance
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
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.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
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.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
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.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
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.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
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