A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
{ "3D-Printed External Breast Prosthesis for Mastectomy Patients", "This study is looking at whether a custom-made, 3D-printed external breast prosthesis can improve how women feel about their appearance and emotional well-being after a mastectomy (surgical removal of the breast) without reconstruction. Traditional external breast prostheses, which are worn on the outside of the body, can sometimes be uncomfortable or not fit well. This study will involve creating a personalized 3D-printed prosthesis for you. We are looking for adults aged 18 or older who have had a mastectomy and have not had breast reconstruction. Your satisfaction with your appearance and emotional well-being will be measured over one year. The study aims to enroll 50 participants.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.", "commitments": "You would undergo measurements and fittings for a 3D-printed external breast prosthesis, receive the prosthesis, and complete questionnaires at baseline, 1 month, 3 months, 6 months, and 1 year.", "compensation": "Not stated in the trial record.", "follow_up": "You would be followed for one year after receiving the prosthesis, with assessments at 1 month, 3 months, 6 months, and 1 year.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Aparna Vijayasekaran, MBBS · PRINCIPAL_INVESTIGATOR · Mayo Clinic
- Sandhya Pruthi, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Patient-reported satisfaction with appearanceAt baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
- Patient-reported emotional well-beingAt baseline, 1 month, 3 months, 6 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.