RecruitingInterventional

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

NCT ID: NCT07047872Sponsor: Mayo ClinicLast updated: 2025-12-09

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.

Arms & interventions

ProcedureComputer-Aided Diagnosis
Undergo CAD development for patient-specific external breast prosthesis model
ProcedureProsthetics Intervention
Undergo measurements for external breast prosthesis
ProcedureProsthetics Intervention
Undergo fitting for 3D-printed external breast prosthesis
ProcedureProsthetics Intervention
Receive 3D-printed external breast prosthesis
OtherQuestionnaire Administration
Ancillary studies

Outcome measures

Primary

Patient-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

Secondary

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting

Nicole G. Sanchez Figueroa · Contact

507-538-6419 sanchezfigueroa.nicole@mayo.edu

Clinical Trials G. Referral Office, MD, MS · Contact

855-776-0015 mayocliniccancerstudies@mayo.edu

Aparna Vijayasekaran, MBBS · Principal Investigator

Sandhya Pruthi, MD · Principal Investigator

Nicole G. Sanchez Figueroa, MD, MS · Sub Investigator

Amy C. Degnim, MD · Sub Investigator

Megan L. Loghry · Sub Investigator

Johnathan M. Morris, MD · Sub Investigator

Victoria A. Sears, MS · Sub Investigator