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

Not Applicable

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT07047872
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-05
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-11-05
• Study Completion: 2026-11-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient-reported satisfaction with appearance	At baseline, 1 month, 3 months, and 1 year	Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Patient-reported emotional well-being	At baseline, 1 month, 3 months, and 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis	At baseline, 1 month, 3 months, and 1 year	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	At baseline, 1 month, 3 months, and 1 year	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	At baseline, 1 month, 3 months, and 1 year	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States