Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Patient financial costs
研究概览
简要总结
The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.
Specific research objectives are to:
- determine financial costs of performing a CEM to breast MRI
- compare time costs involved with CEM to breast MRI
- compare psychologic costs involved with CEM to breast MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > or equal to 30 years
- •Clinically eligible for CEM or breast MRI
- •Newly diagnosed cancer
排除标准
- •Pregnant as verified by patient report. Given that this test is being performed for clinical purposes, the determination of pregnancy status will be resolved via the standard clinical pathway.
结局指标
主要结局
Patient financial costs
时间窗: 24 months
Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
Institutional financial costs
时间窗: 24 months
True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.
Time from diagnosis to first treatment
时间窗: 24 months
Time will be measured in days and abstracted from medical records.
Time from diagnosis to imaging modality (CEM or MRI)
时间窗: 24 months
Time will be measured in days and abstracted from medical records.
Number of patient visits generated from the imaging modality
时间窗: 24 months
Number of patient visits generated from the imaging modality will be abstracted from medical records.
Psychologic costs to patients
时间窗: 24 months
The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
次要结局
未报告次要终点