Recruiting

Genetic Testing

Sponsor:

Columbia University

Code:

NCT07876349

Conditions

Breast Cancer

Ovarian Cancer

Hereditary Cancer Syndrome

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

ELISABETH Evidence-Informed Program (EIP)

Study Details

Brief summary:

The purpose of this research study is to test how well a new approach - using tools built into the electronic health record (EHR)- can help increase genetic testing for hereditary breast and ovarian cancer (HBOC) in women who have a family history that puts them at higher risk. The study will also look at what helps or gets in the way of using these tools in everyday clinical care. As part of this study, the investigators are also evaluating a website called RealRisks, which is designed to support patients in understanding their risk and making informed decisions about genetic testing. By studying how patients and primary care providers use this tool, the investigators hope to improve the way decision support tools are used to guide conversations and decisions about HBOC testing.

Conditions

Breast Cancer

Ovarian Cancer

Hereditary Cancer Syndrome

Study ID

NCT07876349

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women, age 21-75 years
  • Completed Six-Point Scale (SPS) family history screener with a score of 6 or higher.
  • Seen in NewYork Presbyterian primary care clinic selected for pilot testing
  • No personal history of breast or ovarian cancer
  • No prior germline HBOC genetic testing
  • English or Spanish-speaking
  • Access to a smartphone, tablet, or computer
  • Able to provide written, verbal, or online informed consent

Exclusion criteria:

\- Patients who previously participated in the development studies for RealRisks and BNAV.

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: ELISABETH Evidence-Informed Program (EIP)

The ELISABETH evidence-informed program (EIP) to increase HBOC genetic testing in primary care includes: 1) systematic family history intake among women, age 21-75 years, during screening mammography and gynecology clinic visits; 2) tracking patients who meet family history criteria for HBOC genetic testing; 3) notifying patients and primary care providers (PCPs) of positive screens; 4) integrating patient and provider decision support into clinical workflow; 5) facilitating genetic counseling referrals and mainstream genetic testing; 6) providing training for clinic staff to order mainstream genetic testing and deliver post-test counseling for return of results (RoR); 7) providing follow-up care for high-risk patients.

Interventions

ELISABETH Evidence-Informed Program (EIP)

  • Family history screening
  • Patient and provider BPA (Best Practice Alert) notifications
  • Referral information for genetic counseling
  • No RealRisks/BNAV (Breast cancer risk navigation) tools
  • No streamlined MGPT (multigene panel testing) implementation pathway

Primary outcome measure

  • Genetic Testing Knowledge [ Time Frame: Baseline to 1 month ]

Central Contacts and Locations

Central contacts

Research Nurse Navigator

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Research Nurse Navigator

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Katherine Crew, MD

More Information

Sponsor

Columbia University

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Columbia University on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.