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

Completed

• Conditions: Breast Carcinoma
• Interventions: Other: Decision Aid; Procedure: Discussion; Other: Questionnaire Administration

• Registration Number: NCT04693364
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2017-12-27
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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Exclusion Criteria

• Pregnant and breast feeding patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaire, 3D breast model, discussion)	Questionnaire Administration	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.
Observational (questionnaire, 3D breast model, discussion)	Discussion	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.
Observational (questionnaire, 3D breast model, discussion)	Decision Aid	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States