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

Summary

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

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Computer-Aided Diagnosis

  Undergo CAD development for patient-specific external breast prosthesis model

• Procedure
  Prosthetics Intervention

  Undergo measurements for external breast prosthesis

• Procedure
  Prosthetics Intervention

  Undergo fitting for 3D-printed external breast prosthesis

• Procedure
  Prosthetics Intervention

  Receive 3D-printed external breast prosthesis

• Other
  Questionnaire Administration

  Ancillary studies

Location