← Back to Search

RealRisks for Breast Cancer Risk Assessment (FHIR Trial)

N/A

Recruiting

Led By Rita Kukafka, DrPH, MA

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-weeks

Awards & highlights

FHIR Trial Summary

This trial looks to see if combining patient-generated health data with electronic health records can create more accurate risk prediction models for cancer prevention.

Who is the study for?

This trial is for women aged 35-74 who are at high risk of breast cancer, with a predicted 5-year invasive risk of ≥1.7% or lifetime risk ≥20%. Participants must speak English or Spanish and be able to give informed consent. Women with a personal history of breast cancer or those who took part in a related sub-study cannot join.Check my eligibility

What is being tested?

The study is testing 'RealRisks', which combines patient health data from electronic records and patient-generated info to improve the accuracy of breast cancer risk assessments, aiming to personalize prevention strategies and enhance digital health data access.See study design

What are the potential side effects?

Since 'RealRisks' involves data management rather than medication or medical procedures, traditional physical side effects are not applicable. However, participants may experience privacy concerns regarding their health data.

FHIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged between 35 and 74.

Select...

My risk of developing invasive breast cancer is high according to risk models.

FHIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Activation

Secondary outcome measures

Accuracy of perceived breast cancer risk

Other outcome measures

Perceived usability

FHIR Trial Design

1Treatment groups

Experimental Treatment

Group I: FHIR-Enhanced RealRisksExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RealRisks

2018

N/A

~670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,204 Total Patients Enrolled

28 Trials studying Breast Cancer

23,584 Patients Enrolled for Breast Cancer

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

383 Previous Clinical Trials

1,216,304 Total Patients Enrolled

4 Trials studying Breast Cancer

1,955 Patients Enrolled for Breast Cancer

Rita Kukafka, DrPH, MAPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

576 Total Patients Enrolled

1 Trials studying Breast Cancer

276 Patients Enrolled for Breast Cancer

Media Library

FHIR-Enhanced RealRisks Clinical Trial Eligibility Overview. Trial Name: NCT05810025 — N/A

Breast Cancer Research Study Groups: FHIR-Enhanced RealRisks

Breast Cancer Clinical Trial 2023: FHIR-Enhanced RealRisks Highlights & Side Effects. Trial Name: NCT05810025 — N/A

FHIR-Enhanced RealRisks 2023 Treatment Timeline for Medical Study. Trial Name: NCT05810025 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals under 25 years old partake in this medical investigation?

"As per the trial's eligibility requirements, only patients aged between 35 and 74 can join this research study."

Answered by AI

Who is eligible to participate in this clinical trial?

"The trial has a set of criteria that need to be met before entry is allowed, such as having breast cancer and being between 35-74 years old. At present, the research team are trying to recruit 55 patients for their study."

Answered by AI

Is recruitment for this experiment still open?

"Per the information available on clinicaltrials.gov, this trial is not accepting new patients at present. It was initially posted in May 1st 2023 and had its last update March 30th of the same year. Although this specific study has ended recruitment, there are currently 2,632 other research trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rita Kukafka 2023. "FHIR-Enhanced RealRisks to Improve Accuracy of Breast Cancer Risk Assessments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05810025.