Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Boston Medical Center
- Enrollment
- 60
- Primary Endpoint
- Patient financial costs
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > or equal to 30 years
- •Clinically eligible for CEM or breast MRI
- •Newly diagnosed cancer
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Patient financial costs
Time Frame: 24 months
Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
Institutional financial costs
Time Frame: 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
Time Frame: 24 months
Time will be measured in days and abstracted from medical records.
Time from diagnosis to imaging modality (CEM or MRI)
Time Frame: 24 months
Time will be measured in days and abstracted from medical records.
Number of patient visits generated from the imaging modality
Time Frame: 24 months
Number of patient visits generated from the imaging modality will be abstracted from medical records.
Psychologic costs to patients
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported