ClinicalTrials.gg
Enrolling by invitationNCT07911592RAMP-BCUpdated Nov 3, 2026

Breast Cancer Risk Assessment and Management Program

An interventional study of Patient nudge via text message and Patient nudge via phone call in Genetic Predisposition to Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Health services research

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
Female
01

Study summary

The objective of this project is to assess the implementation of evidence-based, digital tools to improve breast cancer risk assessment and related primary cancer prevention services for those at high risk for developing breast cancer.

Read the detailed description

The scientific aims of the study are:

Aim 1: To evaluate the impact of the addition of patient nudge strategies (SMS reminders v. patient phone support) to improve uptake of breast cancer risk assessment. (adoption). Clinical, social, and demographic factors associated with uptake will be a secondary outcome.

Aim 2: To estimate service delivery costs from the health system perspective by collecting data on team-member time (Implementation) Aim 3: To describe critical patient, provider, and systems facilitators and barriers for the implementation process using a multi-stakeholder, mixed-methods approach supported by the PRISM and RE-AIM conceptual frameworks (Adoption, Implementation, Maintenance).

Exploratory aim: To quantify the following clinical outcomes - incidence of high-risk of breast cancer determination, incidence of pathogenic variants identified, proportion of patients at high-risk of developing breast cancer with breast cancer screening imaging ordered within 3 months of high-risk determination, proportion of high-risk patients who complete initial breast cancer screening imaging within 6 months of order.

02

Conditions studied

  • Genetic Predisposition to Cancer
03

In context

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 88 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: Patients will be eligible if they:

  • are between 18-39 years
  • have Sex Assigned at Birth of female in EHR. If Sex Assigned at Birth is not available, Legal Sex of female.
  • received care from Penn Primary care of OB/GYN (Past appointment within 1 year and future appointment within 3 months)

Exclusion Criteria: Patients will be excluded if they:

  • are younger than 18 or older than 39 because breast cancer risk assessment guidelines do not pertain to these groups. Furthermore, women 40 and older also qualify for standard of care breast cancer screening.
  • have Sex Assigned at Birth of male in EHR because breast cancer risk assessment guidelines do not currently pertain to males. If Sex Assigned at Birth is not available, Legal Sex of male.
  • Have been diagnosed with breast cancer via ICD-9 code C50.xx in problem list or medical history
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    EVA Message only

    EVA SMS reminders only

    Other: Patient nudge via text message

  • Experimental
    EVA Message + phone call

    EVA + patient phone support

    Other: Patient nudge via phone call

Interventions

  • OtherPatient nudge via text message

    The intervention involves patient nudge via text message

  • OtherPatient nudge via phone call

    The intervention involves patient nudge via phone call from a study team member. The patient phone call nudge will consist of a study team member calling to inquire about receipt of EVA chatbot and barriers to completion.

06

What researchers measure

Primary outcomes

  1. Uptake of EVA with initial SMS contact

    Uptake is the proportion of subjects who engage the EVA within the first month after contact

    Time frame: 1 month

  2. Uptake of EVA after patient nudge

    Uptake will be summarized as a proportion of individuals who adopt EVA after patient nudge compared to those with no additional nudge. The effect of additional patient support is a comparison of proportions and will be summarized as an odds ratio

    Time frame: 3 months

Secondary outcomes

  1. Uptake of digital counseling intervention

    Proportion of participants eligible for genetic testing who proceed with the digital counseling intervention

    Time frame: 4 months

  2. Uptake of genetic testing

    Proportion of participants eligible for genetic testing who complete genetic testing

    Time frame: 3 months

  3. Uptake of breast imaging

    Proportion of participants deemed at elevated risk for breast cancer who complete screening breast imaging

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartActual
Sep 23, 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2029
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911592
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Sep 23, 2026
Primary completion
Sep 2028 (estimated)
Completion
Sep 2029 (estimated)
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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