Breast Cancer
Conditions
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
Interventions
DIAGNOSTIC_TEST3D printed model
scan
Sponsors
M.D. Anderson Cancer Center
University Cancer Foundation via the Institutional Research Grant program at the University of Texas MD Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren Chang Sen, MD
M.D. Anderson Cancer Center
Outcome results
None listed