3D Printed Breast Models in the Surgical Management of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To learn if providing a 3-D printed model of the breast can help breast cancer patients make decisions related to their care. During this study, some study participants will receive the 3-D printed model and some study participants will receive traditional breast imaging scans to learn if the 3-D printed model

Detailed Description
-----------------
Primary Objective: •The objective of this prospective study is to determine the impact of 3D printed breast models, compared to 2D imaging, on breast cancer patients' decisional conflict related to treatment decision-making. Secondary Objective: To observe if patients will change their initial desired surgical option (mastectomy versus lumpectomy) after viewing the 3D printed models To evaluate the quality of the communication between surgical providers and patients with and without the 3D printed models To assess the surgical outcome including the margin status To evaluate patient satisfaction and well-being post-surgery between the 3D printed model group and the control group as well as mastectomy versus lumpectomy subgroups To assess surgical providers' response to the acceptability and utility of the model

Official Title
-----------------
3D Printed Breast Models in the Surgical Management of Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: 3D printed model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older female Patient must have histologically confirmed breast malignancy Patient is a candidate for surgical management Patient has a surgeon at MDACC (main campus and/or Houston Area Locations) Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations). Patient is able to speak, read or write English Patient is willing to be randomized to the control or 3D printed breast model groups and is willing to sign the consent form. Exclusion Criteria: Pregnant and breastfeeding patients Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side Patients for whom it is not feasible to create a 3D printed breast model from breast MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: 3D printed model<br>a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation. | Diagnostic Test: 3D printed model<br>* scan<br>|
| No Intervention: Arm 2: No 3D printed model<br>Participants will have a standard-of-care surgical consultation using traditional breast imaging. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Conflict Scale (DCS) score questionnaires | Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4 | through study completion; an average of 1 year. |