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

NCT04693364 | Completed

• 2 other identifiers: 2017-0817NCI-2020-13314
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Other: Decision Aid; Procedure: Discussion; Other: Questionnaire Administration

Interventions

Decision Aid OTHER

Use 3D printed breast model

Observational (questionnaire, 3D breast model, discussion)

Discussion PROCEDURE

Participate in consultation

Also known as: Discuss

Observational (questionnaire, 3D breast model, discussion)

Questionnaire Administration OTHER

Complete questionnaires

Observational (questionnaire, 3D breast model, discussion)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pregnant and breast feeding patients

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MDAndersonCancerCenterWebsite

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elsa Arribas

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: December 27, 2017
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

US (1)