Improving Utilization of Supplemental Breast MRI Screening for Women With Extremely Dense Breasts

January 7, 2026 updated by: Abramson Cancer Center at Penn Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care (no nudge)
Usual standard of care, no nudging.
Experimental: Provider nudge only
Nudge sent to provider through EHR.
Behavioral: Provider nudge
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts
Experimental: Patient nudge only
Nudge sent to the patient through text messaging.
Behavioral: Patient nudge
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts
Experimental: Patient and provider nudge
Nudge sent to both provider through EHR, and to patient through text messaging.
Behavioral: Provider nudge
Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts
Behavioral: Patient nudge
Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordering and/or scheduling of supplemental breast MRI
Time Frame: 6 months
Whether a breast MRI is ordered and/or scheduled within 6 months of receiving a nudge.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordering of breast MRI
Time Frame: 6 months
Whether an MRI is ordered within 6 months of receiving a nudge. Analyzed separately from scheduling.
6 months
Scheduling of breast MRI
Time Frame: 6 months
Whether an MRI is scheduled within 6 months of receiving a nudge. Analyzed separately from ordering.
6 months
Completion of breast MRI
Time Frame: 6 months
Whether an MRI is completed within 6 months of receiving a nudge
6 months
False-positive rate
Time Frame: 6 months
False-positive rate among those women who schedule and undergo MRI
6 months
Cancer detection rate
Time Frame: 6 months
Cancer detection rate among those women who schedule and undergo MRI
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anne Marie McCarthy, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2023

Primary Completion (Actual)

April 4, 2025

Study Completion (Actual)

April 4, 2025

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 03123
  • P50CA244690 (U.S. NIH Grant/Contract)
  • 852666 (Registry Identifier: University of Pennsylvania Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Provider nudge

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe