Clinical trial · Observational
Acceptability of 3D Printed Breast Models as Surgical Decision Aids for Breast Cancer Treatment
3D Printed Breast Models: Acceptability of Personalized Models in Breast Cancer Patients
NCT04693364CI-TRIAL-00056974completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to find out the acceptability of a 3D printed breast model by patients as they consider their surgical treatment options. Researchers also want to learn the possible impact of the 3D printed breast model in the patient's decision making process.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid | Other | — | UNRESOLVED |
| Discussion | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (questionnaire, 3D breast model, discussion)
- description
- Patients complete questionnaire over 5 minutes about difficulties in making decision about breast cancer treatment, then participate in a consultation with regular care doctor and study doctor/study staff using the 3D breast model. Patients then complete questionnaires over 5-10 minutes about their opinions on the breast model and different breast surgical treatment options available.
- interventionNames
- Other: Decision Aid
- Procedure: Discussion
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Change in patient decisional conflict
- timeFrame
- 45 minutes - up to 12 months
- description
- Will be assessed based on changes in decisional conflict scale data collected before and after use of the 3 dimensional (3D) printed breast model during consultation with the breast surgeon using paired sample t-tests.
- measure
- Acceptability of the 3D model
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Women diagnosed with breast cancer * Patient is a candidate for surgical management * Patient has a surgeon at MD Anderson Cancer Center (MDACC) (main campus and/or regional care centers) who has agreed to have the 3D model created * Patients with a breast magnetic resonance imaging (MRI) performed at the MD Anderson (at the West Houston location as well as main campus) * Patient able to speak, read or write English * PHYSICIAN ELIGIBILITY: Breast surgeon Exclusion Criteria: * Pregnant and breast feeding patients
References
Publications (0)
Data not yet available
No reference posted for this study.