3D Printed Breast Models in the Surgical Management of Breast Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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:
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To observe if patients will change their initial desired surgical option (mastectomy versus lumpectomy) after viewing the 3D printed models
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To evaluate the quality of the communication between surgical providers and patients with and without the 3D printed models
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To assess the surgical outcome including the margin status
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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
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To assess surgical providers' response to the acceptability and utility of the model
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: 3D printed model a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation. |
Diagnostic Test: 3D printed model
scan
|
| No Intervention: Arm 2: No 3D printed model Participants will have a standard-of-care surgical consultation using traditional breast imaging. |
Outcome Measures
Primary Outcome Measures
- Decision Conflict Scale (DCS) score questionnaires [through study completion; an average of 1 year.]
Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 or older female
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Patient must have histologically confirmed breast malignancy
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Patient is a candidate for surgical management
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Patient has a surgeon at MDACC (main campus and/or Houston Area Locations)
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Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations).
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Patient is able to speak, read or write English
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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:
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Pregnant and breastfeeding patients
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Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side
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Patients for whom it is not feasible to create a 3D printed breast model from breast MRI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer Center
Investigators
- Principal Investigator: Lauren Chang Sen, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2021-1201
- NCI-2023-01852