Improving breast cancer risk assessments using health data integration
Integrating EHR and Patient-generated Health Data for Breast Cancer Risk Assessment and Decision Support in a Diverse Multiethnic Population
This study is testing if combining personal health information with electronic health records can help better assess breast cancer risk for women who are at higher risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 35 Years to 74 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05810025 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the accuracy of breast cancer risk assessments by integrating patient-generated health data (PGHD) with electronic health records (EHRs). It addresses challenges such as missing data in EHRs and seeks to develop more personalized cancer prevention strategies. The study will evaluate how this integration can improve digital access to health data and support policy goals for interoperability. By focusing on high-risk women, the research intends to streamline risk assessment processes and ultimately improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 35-74 years who are identified as high-risk for breast cancer based on specific risk models.
Not a fit: Patients with a personal history of breast cancer or those who have previously participated in a related sub-study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate breast cancer risk assessments and better personalized prevention strategies for women at high risk.
How similar studies have performed: Other studies have shown promise in using integrated health data for risk assessments, but this approach is innovative in its specific focus on breast cancer and the use of FHIR technology.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rita Kukafka, DrPH, MA — Columbia University
- Study coordinator: Rita Kukafka, DrPH, MA
- Email: rk326@cumc.columbia.edu
- Phone: 212-305-9193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.