Clinical trial · Interventional
FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments
Integrating EHR and Patient-generated Health Data for Breast Cancer Risk Assessment and Decision Support in a Diverse Multiethnic Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Electronic health records (EHRs) are an increasingly common source for populating risk models, but whether used to populate validated risk assessment models or to de-facto build risk prediction models, EHR data presents several challenges. The purpose of this study is to assess how the integration of patient generated health data (PGHD) and EHR data can generate more accurate risk prediction models, advance personalized cancer prevention, improve digital access to health data in an equitable manner, and advance policy goals for Patient Generated Health Data (PGHD) and EHR interoperability.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RealRisks | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FHIR-Enhanced RealRisks
- description
- Participants will self-administer FHIR-enhanced RealRisks with access to risk communication games, family history pedigree and modules on chemoprevention and genetics testing, if relevant to them based on their risk and family history. The investigators are interested in gaining short-term feedback on patient activation and other patient reported outcomes, which will be assessed before and within 2 weeks after using RealRisks.
- interventionNames
- Behavioral: RealRisks
Primary outcomes (1)
- measure
- Patient Activation
- timeFrame
- 2-weeks
- description
- Validated 13-item Patient Activation Measure, which measures patient knowledge, skill, and confidence in self-management of health. Scores range from 0 to 100; higher scores indicate greater activation.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Women, age 35-74 years * High-risk defined as 5-year invasive breast cancer risk ≥1.7% or 10 risk ≥20% according to the BCSC or GAIL models * English- or Spanish-speaking * Able to sign informed consent. Exclusion Criteria: * Women with a personal history of breast cancer * Women who previously participated in a sub-study (Aim 1) of the awarded grant.
References
Publications (0)
Data not yet available