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AzTrials

Breast CancerNCT05787249

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

A study testing Patient nudge and Provider nudge in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 74 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Patient nudge and Provider nudge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,358 participants
Where
1 siteUnited States
Study dates
4 Oct 2023to 4 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Provider needs to have ordered the initial screening mammogram
  • Employed by Penn Health System and access to Penn Chart

Who cannot join

  • 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:

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

Other trials in United States

About this study

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Patient nudge, Provider nudge
Keywords
Breast cancer, Breast density, Mammography
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient nudgeBehavioural

    Nudge directed to the patient with the aim of increasing the uptake of MRI in patients with extremely dense breasts

  • Provider nudgeBehavioural

    Nudge directed to the provider with the aim of increasing ordering of MRI in patients with extremely dense breasts

Study groups in NCT05787249
Study groupRoleWhat they receive
Usual care (no nudge)No interventionUsual standard of care, no nudging.
Provider nudge onlyExperimentalNudge sent to provider through electronic health record (EHR).
Receives: Behavioral: Provider nudge
Patient nudge onlyExperimentalNudge sent to the patient through text messaging.
Receives: Behavioral: Patient nudge
Patient and provider nudgeExperimentalNudge sent to both provider through EHR, and to patient through text messaging.
Receives: Behavioral: Patient nudge; Behavioral: Provider nudge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients for Whom Breast MRI Was Ordered and/or Scheduled

    Whether a breast MRI is ordered and/or scheduled within 6 months of the mammogram date

    Measured: 6 months

Secondary outcomes (5)
  1. Number of Patients for Whom Breast MRI Was Ordered

    Whether an MRI is ordered within 6 months of the mammogram date. Analyzed separately from scheduling.

    Measured: 6 months

  2. Number of Patients Who Scheduled a Breast MRI

    Whether an MRI is scheduled within 6 months of the mammogram date. Analyzed separately from ordering.

    Measured: 6 months

  3. Number of Patients Who Completed a Breast MRI

    Whether an MRI is completed within 6 months of the mammogram date

    Measured: 6 months

  4. False-positive Rate

    False-positive rate among those women who schedule and undergo MRI, defined as the number of patients who received a positive MRI result (i.e., BIRADS score of 4 or 5) but did not have a subsequent cancer diagnosis

    Measured: 6 months

  5. Cancer Detection Rate

    Cancer detection rate among those women who schedule and undergo MRI

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start4 Oct 2023
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Factorial
Model description
Two randomization schema are used. Patients are independently randomized to receive a patient-directed nudge or not. Separately, ordering clinicians are assigned to clinic groups based on the clinics in which they practice, and clinic groups are randomized to have a clinician-directed nudge activated each month in a stepped wedge design. This results in four study arms: usual care, patient nudge only, provider nudge only, and both nudges. While clinic groups are the unit of randomization for the clinician-directed nudge, patients at each clinic group could be assigned to any of the four study arms (i.e., usual care or patient nudge only before the clinician-directed nudge is activated; provider nudge arm or both nudges arm after the clinician-directed nudge is activated).
Masking
None (open label)
Enrolment
1,358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787249
Sponsor's protocol ID
UPCC 03123
Other IDs
P50CA244690, 852666
Status last verified
Aug 2024
First submitted
15 Mar 2023
Last updated
2 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pettersson A, Graff RE, Ursin G, Santos Silva ID, McCormack V, Baglietto L, Vachon C, Bakker MF, Giles GG, Chia KS, Czene K, Eriksson L, Hall P, Hartman M, Warren RM, Hislop G, Chiarelli AM, Hopper JL, Krishnan K, Li J, Li Q, Pagano I, Rosner BA, Wong CS, Scott C, Stone J, Maskarinec G, Boyd NF, van Gils CH, Tamimi RM. Mammographic density phenotypes and risk of breast cancer: a meta-analysis. J Natl Cancer Inst. 2014 May 10;106(5):dju078. doi: 10.1093/jnci/dju078.

    PubMed 24816206
  • Bond-Smith D, Stone J. Methodological Challenges and Updated Findings from a Meta-analysis of the Association between Mammographic Density and Breast Cancer. Cancer Epidemiol Biomarkers Prev. 2019 Jan;28(1):22-31. doi: 10.1158/1055-9965.EPI-17-1175. Epub 2018 Sep 11.

    PubMed 30206060
  • Comstock CE, Gatsonis C, Newstead GM, Snyder BS, Gareen IF, Bergin JT, Rahbar H, Sung JS, Jacobs C, Harvey JA, Nicholson MH, Ward RC, Holt J, Prather A, Miller KD, Schnall MD, Kuhl CK. Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening. JAMA. 2020 Feb 25;323(8):746-756. doi: 10.1001/jama.2020.0572.

    PubMed 32096852
  • Veenhuizen SGA, de Lange SV, Bakker MF, Pijnappel RM, Mann RM, Monninkhof EM, Emaus MJ, de Koekkoek-Doll PK, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, van Gils CH, Veldhuis WB; DENSE Trial Study Group. Supplemental Breast MRI for Women with Extremely Dense Breasts: Results of the Second Screening Round of the DENSE Trial. Radiology. 2021 May;299(2):278-286. doi: 10.1148/radiol.2021203633. Epub 2021 Mar 16.

    PubMed 33724062
  • Weinstein SP, Korhonen K, Cirelli C, Schnall MD, McDonald ES, Pantel AR, Zuckerman S, Borthakur A, Conant EF. Abbreviated Breast Magnetic Resonance Imaging for Supplemental Screening of Women With Dense Breasts and Average Risk. J Clin Oncol. 2020 Nov 20;38(33):3874-3882. doi: 10.1200/JCO.19.02198. Epub 2020 Sep 15.

    PubMed 32931396
  • Expert Panel on Breast Imaging; Weinstein SP, Slanetz PJ, Lewin AA, Battaglia T, Chagpar AB, Dayaratna S, Dibble EH, Goel MS, Hayward JH, Kubicky CD, Le-Petross HT, Newell MS, Sanford MF, Scheel JR, Vincoff NS, Yao K, Moy L. ACR Appropriateness Criteria(R) Supplemental Breast Cancer Screening Based on Breast Density. J Am Coll Radiol. 2021 Nov;18(11S):S456-S473. doi: 10.1016/j.jacr.2021.09.002.

    PubMed 34794600
  • Wolf, Tom. "Insurance Company Law of 1921 - Coverage for Mammographic Examinations." The Office Website for the Pennsylvania General Assembly, Pennsylvania General Assembly, 2020, https://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2020&sessInd=0&act=52.

  • Niraula S, Biswanger N, Hu P, Lambert P, Decker K. Incidence, Characteristics, and Outcomes of Interval Breast Cancers Compared With Screening-Detected Breast Cancers. JAMA Netw Open. 2020 Sep 1;3(9):e2018179. doi: 10.1001/jamanetworkopen.2020.18179.

    PubMed 32975573
  • Monsees BS. The Mammography Quality Standards Act. An overview of the regulations and guidance. Radiol Clin North Am. 2000 Jul;38(4):759-72. doi: 10.1016/s0033-8389(05)70199-8.

    PubMed 10943276
  • Sedrak MS, Myers JS, Small DS, Nachamkin I, Ziemba JB, Murray D, Kurtzman GW, Zhu J, Wang W, Mincarelli D, Danoski D, Wells BP, Berns JS, Brennan PJ, Hanson CW, Dine CJ, Patel MS. Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):939-945. doi: 10.1001/jamainternmed.2017.1144.

    PubMed 28430829
  • Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.

    PubMed 30646039
  • Takvorian SU, Bekelman J, Beidas RS, Schnoll R, Clifton ABW, Salam T, Gabriel P, Wileyto EP, Scott CA, Asch DA, Buttenheim AM, Rendle KA, Chaiyachati K, Shelton RC, Ware S, Chivers C, Schuchter LM, Kumar P, Shulman LN, O'Connor N, Lieberman A, Zentgraf K, Parikh RB. Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial. Implement Sci. 2021 Sep 25;16(1):90. doi: 10.1186/s13012-021-01156-6.

    PubMed 34563227
  • Jenssen BP, Schnoll R, Beidas R, Bekelman J, Bauer AM, Scott C, Evers-Casey S, Nicoloso J, Gabriel P, Asch DA, Buttenheim A, Chen J, Melo J, Shulman LN, Clifton ABW, Lieberman A, Salam T, Zentgraf K, Rendle KA, Chaiyachati K, Shelton R, Wileyto EP, Ware S, Leone F. Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke. Implement Sci. 2021 Jul 15;16(1):72. doi: 10.1186/s13012-021-01139-7.

    PubMed 34266468
  • McCarthy AM, Fernandez Perez C, Beidas RS, Bekelman JE, Blumenthal D, Mack E, Bauer AM, Ehsan S, Conant EF, Wheeler BC, Guerra CE, Nunes LW, Gabriel P, Doucette A, Wileyto EP, Buttenheim AM, Asch DA, Rendle KA, Shelton RC, Fayanju OM, Ware S, Plag M, Hyland S, Gionta T, Shulman LN, Schnoll R. Protocol for a pragmatic stepped wedge cluster randomized clinical trial testing behavioral economic implementation strategies to increase supplemental breast MRI screening among patients with extremely dense breasts. Implement Sci. 2023 Nov 24;18(1):65. doi: 10.1186/s13012-023-01323-x.

    PubMed 38001506

Questions about this trial

What is this clinical trial studying?

A study testing Patient nudge and Provider nudge in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients for Whom Breast MRI Was Ordered and/or Scheduled (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787249, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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