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Recruiting NCT07047872

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

No phase Interventional Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computer-Aided Diagnosis, Prosthetics Intervention, Prosthetics Intervention, Prosthetics Intervention.
Who it may be relevant to
Registry conditions: Breast Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • Patient-reported satisfaction with appearance [Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year]
  • Patient-reported emotional well-being [Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year]
Secondary outcome measures (3)
  • Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis [Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year]
  • Patient-reported fit of personalized 3D-printed breast prosthesis [Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year]
  • Patient-reported satisfaction with personalized 3D-printed breast prosthesis [Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year]

Eligibility criteria

Inclusion criteria

  • 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
  • Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
  • Ability to provide informed consent
  • Ability to complete study procedures, including surface scanning (with temporary fiducial skin markers), standardized photography, and surveys at 1, 3, 6, and 12 months

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)
  • 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
  • Patients unwilling or unable to undergo surface scanning, standardized photography, or complete survey follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07047872 · 24-004692 · NCI-2024-10468 · 24-004692

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗