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

N/AActive Not RecruitingNCT05755984

M.D. Anderson Cancer Center20 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

3D printed modelDIAGNOSTIC_TEST

scan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Decision Conflict Scale (DCS) score questionnaires

Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4

Time frame: through study completion; an average of 1 year.

Data from ClinicalTrials.gov

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