Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Other: State-Trait Anxiety Inventory (STAI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consent for the entire study<br>Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging. | Other: State-Trait Anxiety Inventory (STAI)<br>* The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.<br>|
| Active Comparator: Consent only for the STAI<br>Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging. | Other: State-Trait Anxiety Inventory (STAI)<br>* The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Institutional financial costs | 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. | 24 months | 
| Patient financial costs | Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges. | 24 months | 
| Time from diagnosis to imaging modality (CEM or MRI) | Time will be measured in days and abstracted from medical records. | 24 months | 
| Time from diagnosis to first treatment | Time will be measured in days and abstracted from medical records. | 24 months | 
| Number of patient visits generated from the imaging modality | Number of patient visits generated from the imaging modality will be abstracted from medical records. | 24 months | 
| Psychologic costs to patients | 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. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast enhanced mammography (CEM), Breast MRI, Financial costs, Time costs, State-trait anxiety inventory (STAI)