Nudges for MRI Screening in Women with Dense Breasts

No longer recruiting at 1 trial location

Overseen By Claudia Fernandez Perez, MHS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Breast cancer history, Recent ultrasound, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to encourage more women with extremely dense breasts to undergo MRI screenings. It examines whether reminders (nudges) to patients, doctors, or both increase MRI use and whether the effect differs between Black and White women. Women who have had a mammogram within the last six months at specific Penn hospitals and have not had a breast MRI in the past two years might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance breast cancer screening practices.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these nudges are safe for increasing MRI utilization?

Research shows that reminders to encourage MRI screenings are generally safe. These reminders, sent via text or electronic health records, prompt patients or their healthcare providers. Studies have found that these reminders are well-received and have not caused any serious problems. The main goal is to determine if these gentle prompts can increase MRI screenings among women with dense breasts. The idea is to help both patients and doctors remember and act on the need for these screenings.

In short, reminders are not medications or treatments, so they don't carry physical risks or side effects. They provide a safe way to encourage healthy actions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how simple nudges can improve MRI screening rates for women with dense breasts, which is crucial for early cancer detection. Unlike traditional methods that rely solely on patient initiative or routine doctor recommendations, this approach uses digital nudges to encourage action. These nudges are sent via electronic health records to providers and text messages to patients, making it a novel way to prompt timely screenings. By leveraging technology to enhance communication and decision-making, the trial aims to uncover whether these nudges can significantly increase screening rates, potentially leading to earlier interventions and better outcomes.

What evidence suggests that this trial's nudges could be effective for increasing MRI utilization in women with dense breasts?

Research has shown that gentle reminders, or "nudges," can increase MRI screening rates for women with very dense breast tissue. In this trial, participants may join different groups to assess the effectiveness of these nudges. One group will receive a provider nudge, where doctors get reminders through electronic health records. Studies have shown this can lead to about 22% of patients undergoing these tests. Another group will receive a patient nudge, where women receive text message reminders, making them more likely to schedule an MRI. In a third group, both doctors and patients receive reminders, potentially leading to even stronger effects and more screenings. These nudges encourage both patients and doctors to prioritize necessary screenings. ^{1 2 3 4 6}

Who Is on the Research Team?

Anne Marie McCarthy, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for women aged 40-74 with extremely dense breasts who had a non-actionable mammogram within the last 6 months at specified Penn Medicine locations. They must have a valid mobile number, and their provider should have ordered the initial mammogram. Women with prior breast cancer or recent MRI/ultrasound are excluded.

Inclusion Criteria

I have a working mobile phone number.

My doctor has ordered my first mammogram.

You had a mammogram within the last 6 months that didn't show any concerning issues.

Exclusion Criteria

You have not had a breast MRI in the last 2 years.

You have not had an ultrasound recently or at the same time as the study.

I have had breast cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive nudges through EHR and/or text messaging to increase MRI utilization

6 months

Follow-up

Participants are monitored for MRI ordering, scheduling, and completion, as well as false-positive and cancer detection rates

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient nudge
• Provider nudge

Trial Overview The study tests if 'nudges' to either patients, providers, or both can increase breast MRI screenings among women with very dense breasts. It also examines if there's a difference in response between Black and White women.

How Is the Trial Designed?

Group I: Provider nudge only Experimental Treatment 1 Intervention

Nudge sent to provider through EHR.

Group II: Patient nudge only Experimental Treatment 1 Intervention

Nudge sent to the patient through text messaging.

Group III: Patient and provider nudge Experimental Treatment 2 Interventions

Nudge sent to both provider through EHR, and to patient through text messaging.

Group IV: Usual care (no nudge) Active Control 1 Intervention

Usual standard of care, no nudging.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05787249

Improving Utilization of Supplemental Breast MRI ... 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 ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-05152

Provider and Patient Nudges for Improving Rates of ... This clinical trial tests whether provider and/or patient nudges improve rates of supplemental breast magnetic resonance imaging (MRI) referral and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10668465/

Protocol for a pragmatic stepped wedge cluster ... A 2 × 2 randomized pragmatic trial will test nudges to patients, clinicians, both, or neither to promote supplemental breast MRI screening.

4. aacrjournals.org aacrjournals.org/cebp/article/33/9_Supplement/A136/748144/Abstract-A136-Design-and-interim-review-of-a

Abstract A136: Design and interim review of a pragmatic ... The provider nudge was successfully delivered 97% of the time. Overall, MRIs have been ordered for about 22% of patients across all study arms.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424003367?via%3Dihub

Increasing screening for breast cancer using a randomized ... Although prior nudges were effective for improving a variety of health behaviors, improving complex behaviors such as mammogram screening that involve both ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003367

Increasing screening for breast cancer using a randomized ... The purpose of this trial is to examine the effectiveness of a multi-component nudge intervention to increase breast cancer screening among eligible primary ...