Breast Carcinoma
Conditions
Brief summary
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
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.
Interventions
OTHERDecision Aid
Use 3D printed breast model
PROCEDUREDiscussion
Participate in consultation
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient decisional conflict | 45 minutes - up to 12 months | 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. |
| Acceptability of the 3D model | 45 minutes - up to 12 months | 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. |
Countries
United States
Outcome results
None listed