RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-05
Study Completion:2026-11-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07047872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult individuals aged 18 years or older
  2. * Have undergone mastectomy for breast cancer treatment without subsequent breast reconstruction
  3. * Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
  4. * Ability to provide informed consent
  1. * Individuals with contraindications for participation, such as severe medical conditions that may interfere with study procedures
  2. * Lack of willingness or capacity to provide informed consent for study participation
  3. * Inability to communicate effectively in the study language (e.g., English)

Contacts and Locations

Study Contact

Aparna Vijayasekaran
CONTACT
507-538-1701
vijayasekaran.aparna@mayo.edu
Nicole G. Sanchez Figueroa, MD, MS
CONTACT
507-538-6419
sanchezfigueroa.nicole@mayo.edu

Principal Investigator

Aparna Vijayasekaran, MBBS
PRINCIPAL_INVESTIGATOR
Mayo Clinic
Sandhya Pruthi, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Aparna Vijayasekaran, MBBS, PRINCIPAL_INVESTIGATOR, Mayo Clinic
  • Sandhya Pruthi, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-05
Study Completion Date2026-11-05

Study Record Updates

Study Start Date2024-11-05
Study Completion Date2026-11-05

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Carcinoma