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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10468 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-004692 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (3D-printed external breast prosthesis) | Experimental | Patients undergo CT, development of a patient-specific external breast prosthesis model using CAD, and measurements for 3D-printed external breast prosthesis during screening. Patients then undergo fitting for and receive the 3D-printed external breast prosthesis on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Aided Diagnosis | Procedure | Undergo CAD development for patient-specific external breast prosthesis model |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported satisfaction with appearance | Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively. | 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. | At baseline, 1 month, 3 months, 6 months, and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis | Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied. | At baseline, 1 month, 3 months, 6 months, and 1 year |
| Patient-reported fit of personalized 3D-printed breast prosthesis |
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Inclusion Criteria:
Adult individuals aged 18 years or older
History of unilateral or bilateral mastectomy for any indication
No implant or autologous reconstruction
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aparna Vijayasekaran | Contact | 507-538-1701 | vijayasekaran.aparna@mayo.edu | |
| Nicole G. Sanchez Figueroa, MD, MS | Contact | 507-538-6419 | sanchezfigueroa.nicole@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aparna Vijayasekaran, MBBS | Mayo Clinic | Principal Investigator |
| Sandhya Pruthi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Prosthetics Intervention | Procedure | Undergo measurements for external breast prosthesis |
|
| Prosthetics Intervention | Procedure | Undergo fitting for 3D-printed external breast prosthesis |
|
| Prosthetics Intervention | Procedure | Receive 3D-printed external breast prosthesis |
|
| Questionnaire Administration | Other | Ancillary studies |
|
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied. |
| At baseline, 1 month, 3 months, 6 months, and 1 year |
| Patient-reported satisfaction with personalized 3D-printed breast prosthesis | 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. | At baseline, 1 month, 3 months, 6 months, and 1 year |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003936 | Diagnosis, Computer-Assisted |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
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