Acceptability of 3D Printed Breast Models as Surgical Decision Aids for Breast Cancer Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine feasibility and explore the acceptability of 3 dimensional (3D) printed breast models as a decision aid in breast cancer treatment decision making. OUTLINE: 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.

Official Title
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3D Printed Breast Models: Acceptability of Personalized Models in Breast Cancer Patients

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Other: Decision Aid
* Procedure: Discussion
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire, 3D breast model, discussion)<br>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. | Other: Decision Aid<br>* Use 3D printed breast model<br>Procedure: Discussion<br>* Participate in consultation<br>* Other names: Discuss;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient decisional conflict | 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. | 45 minutes - up to 12 months | 
| Acceptability of the 3D model | Will be measured with questions adapted from the Ottawa measures. 'Acceptability' (of a decision aid) refers to ratings regarding the comprehensibility of components of a decision aid, its length, pace (if audio-visual), amount of information, balance in presentation of information about options, and overall suitability for decision making. Responses are reported descriptively in terms of the proportions of patients responding positively or negatively on each criterion. | 45 minutes - up to 12 months |