EHR Intervention to Increase HBOC Genetic Testing
Electronic Health Record-based Implementation Strategies and Decision Support for Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Among Heterogeneous Women (ELISABETH) Pragmatic Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 75 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether tools in electronic health records help more women get genetic testing for inherited breast and ovarian cancer risk. It is for women whose family history puts them at higher risk. The study also tests RealRisks, a website that helps patients understand their risk and decide about testing.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women ages 21–75.
- Completed the Six-Point Scale family history screening with a score of 6 or higher.
- Seen at a NewYork Presbyterian primary care clinic chosen for this study.
- Have never had breast or ovarian cancer.
- Have never had genetic testing for inherited breast and ovarian cancer risk.
- Speak English or Spanish.
- Have access to a smartphone, tablet, or computer.
- Can give informed consent—agree to join after learning about the study—in writing, by speaking, or online.
Who can't join
- Previously took part in studies to develop RealRisks or BNAV.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
NY
- Columbia University Irving Medical Center · New York, NY 10032Research Nurse Navigator · Study contact · 212-342-5162 · cancerclinicaltrials@cumc.columbia.eduKatherine Crew, MD · Principal investigatorMore trials in New York