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FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments

NCT05810025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-11

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

RealRisks

RealRisks is a web-based patient-centered decision aid (DA) designed to improve: 1) accuracy of breast cancer risk perceptions; 2) chemoprevention knowledge, and 3) informed choice. The DA includes audio and modules about breast cancer risk (including interactive games on risk communication) and chemoprevention. Through RealRisks, the investigators will collect information on breast cancer risk factors to calculate a patient's BCSC breast cancer risk score and also factors that influenced decision-making about chemoprevention through the preference elicitation game. RealRisks generates an action plan for patients summarizing their personalized breast cancer risk profile and preference elicitation for chemoprevention. Of note, the tool is designed for patients with varying levels of health literacy and numeracy and is available in English and Spanish.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Rita Kukafka, DrPH, MA · Columbia University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810025 on ClinicalTrials.gov