RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Integrating EHR and Patient-generated Health Data for Breast Cancer Risk Assessment and Decision Support in a Diverse Multiethnic Population

Quick Facts

Study Start:2023-06-01
Study Completion:2025-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05810025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 74 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women, age 35-74 years
  2. * High-risk defined as 5-year invasive breast cancer risk ≥1.7% or 10 risk ≥20% according to the BCSC or GAIL models
  3. * English- or Spanish-speaking
  4. * Able to sign informed consent.
  1. * Women with a personal history of breast cancer
  2. * Women who previously participated in a sub-study (Aim 1) of the awarded grant.

Contacts and Locations

Study Contact

Rita Kukafka, DrPH, MA
CONTACT
212-305-9193
rk326@cumc.columbia.edu
Katherine Crew, MD, MS
CONTACT
212-305-1732
kd59@cumc.columbia.edu

Principal Investigator

Rita Kukafka, DrPH, MA
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Rita Kukafka, DrPH, MA, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2025-04-15

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2025-04-15

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer