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Trial Title:
Improving Utilization of Supplemental Breast MRI Screening for Women with Extremely Dense Breasts
NCT ID:
NCT05787249
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Breast density
Mammography
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient nudge
Description:
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients
with extremely dense breasts
Arm group label:
Patient and provider nudge
Arm group label:
Patient nudge only
Intervention type:
Behavioral
Intervention name:
Provider nudge
Description:
Nudge directed to the provider with the aim of increasing ordering of MRI in patients
with extremely dense breasts
Arm group label:
Patient and provider nudge
Arm group label:
Provider nudge only
Summary:
The goal of this study is to increase MRI utilization among women with extremely dense
breasts. The main question it seeks to answer is whether nudging of the provider,
patient, or both increases the uptake of MRI among this group, and whether this effect
differs between Black and White women.
Detailed description:
Women with dense breasts have 3-5-fold increased risk for breast cancer as women without
dense breasts. Dense breast tissue can "mask" small tumors, leading to reduced
mammography sensitivity. Recent randomized controlled trials demonstrate that
supplemental breast MRI screening improves detection of small, invasive cancers that are
not detected by mammography. In January 2022, a Pennsylvania law went into effect
mandating insurance coverage of supplemental screening for women with extremely dense
breasts. Currently only a small fraction of eligible women with extremely dense breasts
are receiving supplemental breast MRI screening. Clinical pathways to identify patients
who are eligible for insurance coverage of supplemental breast MRI screening and
communicate this option to patients and providers are needed to ensure equitable access
to supplemental screening. This study therefore proposes a stepped wedge cluster
randomized clinical trial to determine whether electronic health record (EHR) and secure
text message nudges increase utilization of supplemental breast MRI screening among
eligible women with extremely dense breasts.
Criteria for eligibility:
Criteria:
Patient participants:
Inclusion Criteria:
- Women aged 40-74
- Recent non-actionable mammogram of less than 6 months
- Mammogram performed at Penn Center for Advanced Medicine, Penn Presbyterian
Hospital, Pennsylvania Hospital, or Radnor
- Valid mobile phone number
Exclusion Criteria:
- Prior history of breast cancer
- No breast MRI within the past 2 years
- No prior actionable mammogram within 6 months
- No recent or concurrent ultrasound
Provider participants:
Inclusion Criteria:
- Provider needs to have ordered the initial screening mammogram
- Employed by Penn Health System and access to Penn Chart
Gender:
Female
Minimum age:
40 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Bala Cynwyd
Zip:
19004
Country:
United States
Start date:
October 4, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787249
