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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

Must not have

Women with a personal history of breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged between 35 and 74.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast cancer before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Activation

Secondary study objectives

Accuracy of perceived breast cancer risk

Other study objectives

Perceived usability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met