RecruitingNot ApplicableNCT07047872

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

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

Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is providing custom 3D-printed breast prostheses (external breast forms) to women who had a mastectomy but did not have reconstruction, and measuring whether these personalized prostheses improve their quality of life, body image, and comfort compared to standard off-the-shelf options. **You may be eligible if...** - You are 18 or older and have had a single or double mastectomy for any reason - You did not have breast reconstruction (implant or tissue flap) - You are willing to be scanned, photographed, and complete surveys over 12 months **You may NOT be eligible if...** - You have serious medical conditions that prevent study participation - You have open wounds, active skin infections, or skin conditions on your chest that would interfere with scanning or wearing the prosthesis - You are unable or unwilling to give informed consent - You cannot communicate effectively in the study language Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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