Acceptability of 3D Printed Breast Models as Surgical Decision Aids for Breast Cancer Treatment
2022年3月4日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
30
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Texas
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Houston、Texas、美国、77030
- M D Anderson Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Women with breast cancer who are candidates for surgical management and agreed to have a 3D model created
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
|
完成问卷
Use 3D printed breast model
Participate in consultation
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in patient decisional conflict
大体时间：45 minutes - up to 12 months
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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.
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45 minutes - up to 12 months
|
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Acceptability of the 3D model
大体时间：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.
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45 minutes - up to 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elsa Arribas、M.D. Anderson Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年12月27日
初级完成 (实际的)
2022年2月22日
研究完成 (实际的)
2022年2月22日
研究注册日期
首次提交
2020年12月28日
首先提交符合 QC 标准的
2020年12月30日
首次发布 (实际的)
2021年1月5日
研究记录更新
最后更新发布 (实际的)
2022年3月8日
上次提交的符合 QC 标准的更新
2022年3月4日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.