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

Sponsor

Boston Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008301

Collaborator

Breast Cancer Alliance (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Other: State-Trait Anxiety Inventory (STAI)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Consent for the entire study 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) The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.
Active Comparator: Consent only for the STAI 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) The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.

Arm

Intervention/Treatment

Experimental: Consent for the entire study

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)

The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.

Active Comparator: Consent only for the STAI

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)

The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.