An interventional study of Post-visit patient text messaging and Default pended order in Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 2 sites in United States. Open to female participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Health services research
In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).
Cancer is a leading cause of mortality in the United States. While strong USPSTF guideline recommendations support appropriate screening for early detection and to avoid preventable deaths, breast cancer screening is often underutilized. Increasing breast cancer screening rates is challenging, in part, because it requires complementary decisions from clinicians (e.g., recommend and counsel patients about screening) and patients (e.g., to internalize risks and choose to complete screening). Presently, the lack of interventions directly targeting both clinicians' and patients' decision-making may underscore the relatively stagnant screening rates in the United States. There is a significant need to develop and scale low-cost interventions that increase breast cancer screening while simultaneously addressing the needs of high-risk patients and reducing disparities. Building upon prior work, the investigators propose to develop and test EHR-based clinician and patient nudges, with an additional intensified nudge to high-risk patients, to help increase screening mammography rates.
This study consists of two complementary and concurrent, cluster-randomized, pragmatic trials to be conducted at Penn and UH.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 21,123 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients must meet the following criteria to be eligible:
For the Penn Trial patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:
Exclusion Criteria:
Patients will be excluded from the study if:
Clinics randomized to the control arm will receive standard of care.
Clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be post-visit text message reminders (standard messaging content). Clinician nudges will be default pended orders.
Behavioral: Post-visit patient text messaging · Behavioral: Default pended order
Patients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component.
Behavioral: Post-visit patient text messaging · Behavioral: Default pended order · Behavioral: High risk bidirectional post-visit text messaging
Primary care providers randomized to the control arm will receive standard of care.
Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.
Behavioral: Default pended order
Patients will be sent text message reminders 4 days and 14 days after their primary care visit. The message delivered 4-days post-visit will remind the patient that a screening mammogram was recently ordered by their doctor, that appointments have been reserved for them, and to pre-commit to scheduling. The message delivered at 14-days post-visit will remind the patient of their recent screening mammogram order and encourage them to schedule their appointment, if one has not already been scheduled.
A default pended order for a mammogram will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.
High risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component after their visit. This intervention will query the patient about common questions or concerns about breast cancer screening. The bi-directional text messaging intervention will provide additional educational materials based on patient response as well as information about resources to help navigate to screening.
Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
Time frame: 3 months
Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit
The secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit.
Time frame: 6 months
Waiver of informed consent obtained. Penn patients were identified 1 day prior to an eligible primary care visit between 12/18/23-7/1/24. UH patients were identified 1-3 days prior to an eligible primary care visit between 2/7/24-10/7/24. Patients only counted once within the study window at their first primary care visit. Total protocol enrollment: 21,123 patients (14,905 at Penn and 6,218 at UH). No clinicians were individually enrolled as participants and no clinician outcomes were evaluated.
| Milestone | Penn: Control | Penn: Intervention | Penn: High Risk - Standard Messaging | Penn: High Risk - Intensification Messaging | UH: Control | UH: Intervention |
|---|---|---|---|---|---|---|
| Started | 4513 | 10392 | 0 | 0 | 3075 | 3143 |
| Completed | 4513 | 10392 | 0 | 0 | 3075 | 3143 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Penn: Control | Penn: Intervention | Penn: High Risk - Standard Messaging | Penn: High Risk - Intensification Messaging | UH: Control | UH: Intervention |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 2270 | 2260 | 0 | 0 |
| Completed | 0 | 0 | 2270 | 2260 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.
| Participants | Penn: Control | Penn: Intervention | Penn: High Risk - Standard Messaging | Penn: High Risk - Intensification Messaging | UH: Control | UH: Intervention |
|---|---|---|---|---|---|---|
| Proportion of Patients Who Complete a Screening Mammogram Within 3 Months After the Visit | 943 | 2810 | 511 | 549 | 1167 | 1390 |
The secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit.
| Participants | Penn: Control | Penn: Intervention | Penn: High Risk - Standard Messaging | Penn: High Risk - Intensification Messaging | UH: Control | UH: Intervention |
|---|---|---|---|---|---|---|
| Proportion of Patients Who Complete a Screening Mammogram Within 6 Months After the Visit | 1401 | 3912 | 732 | 751 | 1417 | 1620 |
Collected over Each patient was monitored for adverse events for 6 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through March 18, 2024 and again at the end of the trial follow up period, 6 months after enrollment ended for both sites (April 2025), for all enrolled participants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Penn: Control | — | — | 0/4,513 (0%) |
| Penn: Intervention | — | — | 59/10,392 (0.6%) |
| UH: Control | — | — | 1/3,075 (0%) |
| UH: Intervention | — | — | 1/3,143 (0%) |
| Event | Penn: Control | Penn: Intervention | UH: Control | UH: Intervention |
|---|---|---|---|---|
| Messaging Opt-outSocial circumstances | — | 51/10392 | 0/3075 | 0/3143 |
| Duplicate MammogramSurgical and medical procedures | 0/4513 | 8/10392 | 1/3075 | 1/3143 |
Baseline characteristics are reported for the Main Study Period only - Cluster Level Randomization (Control and Intervention). Patients in the Penn High Risk arms are accounted for in the Intervention arm as a whole, but were additionally randomized at the Individual Level, as noted in the Participant Flow. At UH, clinicians were randomized but no clinicians were individually enrolled as participants. All analyses were done at the participant level at both Penn and UH.
| Age, Continuous(years) | Penn: Control | Penn: Intervention | UH: Control | UH: Intervention | Total |
|---|---|---|---|---|---|
| Mean | 55.5 ± 10.1 | 56.3 ± 10.2 | 57.9 ± 9.7 | 57.9 ± 9.6 | 56.6 ± 10.1 |
| Sex: Female, Male(Participants) | Penn: Control | Penn: Intervention | UH: Control | UH: Intervention | Total |
|---|---|---|---|---|---|
| Female | 4513 | 10392 | 3075 | 3143 | 21123 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Penn: Control | Penn: Intervention | UH: Control | UH: Intervention | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 19 | 26 | 7 | 2 | 54 |
| Asian | 159 | 466 | 44 | 38 | 707 |
| Native Hawaiian or Other Pacific Islander | 12 | 20 | 1 | 2 | 35 |
| Black or African American | 2176 | 2841 | 259 | 252 | 5528 |
| White | 1703 | 6132 | 2626 | 2707 | 13168 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 444 | 907 | 138 | 142 | 1631 |
| Race/Ethnicity, Customized(Participants) | Penn: Control | Penn: Intervention | UH: Control | UH: Intervention | Total |
|---|---|---|---|---|---|
| Hispanic Latino | 235 | 401 | 73 | 46 | 755 |
| Not Hispanic or Latino | 4165 | 9713 | 2736 | 2843 | 19457 |
| Unknown | 113 | 278 | 266 | 254 | 911 |
| Insurance Type(Participants) | Penn: Control | Penn: Intervention | UH: Control | UH: Intervention | Total |
|---|---|---|---|---|---|
| Medicare | 1014 | 2590 | 680 | 691 | 4975 |
| Medicaid | 840 | 1041 | 94 | 108 | 2083 |
| Commercial | 2510 | 6377 | 2220 | 2279 | 13386 |
| Other | 149 | 384 | 81 | 65 | 679 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abramson Cancer Center at Penn Medicine