Acceptability of 3D Printed Breast Models as Surgical Decision Aids for Breast Cancer Treatment
March 4, 2022 updated by: M.D. Anderson Cancer Center
3D Printed Breast Models: Acceptability of Personalized Models in Breast Cancer Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with breast cancer who are candidates for surgical management and agreed to have a 3D model created
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational (questionnaire, 3D breast model, 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.
|
Complete questionnaires
Use 3D printed breast model
Participate in consultation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in patient decisional conflict
Time Frame: 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.
|
45 minutes - up to 12 months
|
|
Acceptability of the 3D model
Time Frame: 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.
|
45 minutes - up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elsa Arribas, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2017
Primary Completion (Actual)
February 22, 2022
Study Completion (Actual)
February 22, 2022
Study Registration Dates
First Submitted
December 28, 2020
First Submitted That Met QC Criteria
December 30, 2020
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
March 8, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0817 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-13314 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.