3D Printed Breast Models in the Surgical Management of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Decision Conflict Scale (DCS) score questionnaires
研究概览
简要总结
To learn if providing a 3-D printed model of the breast can help breast cancer patients make decisions related to their care. During this study, some study participants will receive the 3-D printed model and some study participants will receive traditional breast imaging scans to learn if the 3-D printed model
详细描述
Primary Objective:
•The objective of this prospective study is to determine the impact of 3D printed breast models, compared to 2D imaging, on breast cancer patients' decisional conflict related to treatment decision-making.
Secondary Objective:
- To observe if patients will change their initial desired surgical option (mastectomy versus lumpectomy) after viewing the 3D printed models
- To evaluate the quality of the communication between surgical providers and patients with and without the 3D printed models
- To assess the surgical outcome including the margin status
- To evaluate patient satisfaction and well-being post-surgery between the 3D printed model group and the control group as well as mastectomy versus lumpectomy subgroups
- To assess surgical providers' response to the acceptability and utility of the model
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older female
- •Patient must have histologically confirmed breast malignancy
- •Patient is a candidate for surgical management
- •Patient has a surgeon at MDACC (main campus and/or Houston Area Locations)
- •Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations).
- •Patient is able to speak, read or write English
- •Patient is willing to be randomized to the control or 3D printed breast model groups and is willing to sign the consent form.
排除标准
- •Pregnant and breastfeeding patients
- •Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side
- •Patients for whom it is not feasible to create a 3D printed breast model from breast MRI
研究组 & 干预措施
Arm 1: 3D printed model
a 3-D printed model of your breast will be created and discussed with participants during your surgical consultation.
干预措施: 3D printed model (Diagnostic Test)
Arm 2: No 3D printed model
Participants will have a standard-of-care surgical consultation using traditional breast imaging.
结局指标
主要结局
Decision Conflict Scale (DCS) score questionnaires
时间窗: through study completion; an average of 1 year.
Score scale ranges: Strongly Agree 1, Agree 2 Neither agree or Agree 3 Strongly Disagree 4
次要结局
未报告次要终点