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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693364
• Other study ID #: 2017-0817
• Secondary ID: NCI-2020-1331420
• Status: Completed
• Start date: December 27, 2017
• Est. completion date: February 22, 2022

Study information

• Verified date: March 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Other:
• Decision Aid
Use 3D printed breast model

Procedure:
• Discussion
Participate in consultation

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   MDAndersonCancerCenterWebsite