Incorporating Three-Dimensional Visualization in Breast Reconstruction Consultation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- BREAST-Q Satisfaction
研究概览
简要总结
The purpose of this study is to find out whether using an interactive 3D tool during a standard surgical consultation can lead to greater patient satisfaction with the information provided about breast reconstruction options than the standard consultation alone. The study researchers will also assess whether women whose surgical consultation includes the use of the 3D tool are more satisfied with their breasts and with the decisions they made about their reconstruction procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Presenting at MSK for initial breast reconstruction consultation
- •Planning to undergo mastectomy at time of consultation
- •English spoken as primary language
- •Able to provide informed consent without a legally authorized representative
排除标准
- •Prior breast reconstruction
- •Prior breast reconstruction consultation with a plastic surgeon
研究组 & 干预措施
Standard consultation with interactive 3D visualization
Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.
干预措施: interactive 3D tool (Other)
Standard consultation with interactive 3D visualization
Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.
干预措施: BREAST-Q Reconstruction Module (Other)
Standard consultation with interactive 3D visualization
Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.
干预措施: DQI (Other)
Standard consultation with interactive 3D visualization
Participants in this group will use the interactive 3D tool in addition to receiving the standard surgical consultation before their breast reconstruction procedure.
干预措施: Ottawa Decision Regret Scale (Other)
Standard consultation
Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.
干预措施: BREAST-Q Reconstruction Module (Other)
Standard consultation
Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.
干预措施: DQI (Other)
Standard consultation
Participants in this group will receive a standard surgical consultation before their breast reconstruction procedure.
干预措施: Ottawa Decision Regret Scale (Other)
结局指标
主要结局
BREAST-Q Satisfaction
时间窗: 4 weeks
scores at 4 weeks (T2) Scores for each domain of the BREAST-Q range from 0 to 100, implying a continuum of increasing satisfaction or better quality of life.
次要结局
- BREAST-Q Satisfaction(3 months after surgery)