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

NCT05810025 | Completed DMC

• 2 other identifiers: AAAU1629R21MD017654
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Electronic Health Record; Decision Aid; Fast Healthcare Interoperability Resources (FHIR); Breast Cancer Risk Assessment; Lobular Carcinoma In Situ; Atypical Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Patient Activation

  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.

  2-weeks

Secondary Outcomes (1)

• Accuracy of perceived breast cancer risk

  2-weeks

Other Outcomes (1)

• Perceived usability

  2-weeks

Study Arms (1)

FHIR-Enhanced RealRisks

EXPERIMENTAL

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.

Behavioral: RealRisks

Interventions

RealRisks BEHAVIORAL

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.

Also known as: FHIR-Enhanced RealRisks

FHIR-Enhanced RealRisks

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with a personal history of breast cancer
• Women who previously participated in a sub-study (Aim 1) of the awarded grant.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Rita Kukafka, DrPH, MA

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomedical Informatics and Sociomedical Sciences; Department of Biomedical Informatics Chief Diversity Officer

Model Details: RealRisks is a patient-facing, web-based decision support tool that was developed using multiple design sessions, participatory workshops, and usability studies to arrive at guiding principles that focus on 1) personalized breast cancer risk calculation, 2) interactive games to communicate breast cancer risk, and 3) patient preferences elicitation to elicit values supporting breast cancer options. The FHIR enhanced-RealRisks functionality that this research focuses on will allow RealRisks to utilize a patient's electronic health record data to support accurate risk assessment.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)