Breast CancerELISABETHNCT07876349
EHR Intervention to Increase HBOC Genetic Testing
A study testing ELISABETH Evidence-Informed Program (EIP) in people with Breast Cancer and Ovarian Cancer, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Hereditary Cancer Syndrome
- What is being tested?
- ELISABETH Evidence-Informed Program (EIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who previously participated in the development studies for RealRisks and BNAV.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Research Nurse Navigator, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
Katherine Crew, MD
About this study
Official title: Electronic Health Record-based Implementation Strategies and Decision Support for Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Among Heterogeneous Women (ELISABETH) Pragmatic Trial
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.
Read the detailed description
About 5-10% of breast cancers and 10-15% of ovarian cancers are attributed to pathogenic variants (PVs) in cancer predisposition genes, such as BRCA1 and BRCA2. Identifying women with PVs in hereditary breast and ovarian cancer (HBOC) genes can inform risk management strategies, such as enhanced cancer screening, risk-reducing surgeries, and chemoprevention, which have been shown to reduce cancer incidence and mortality. There is significant underutilization of HBOC genetic testing in primary care, with women of color and lower socioeconomic status less likely to receive testing compared to their White or higher income counterparts. Barriers include lack of systematic family history intake, limited access to genetic counseling services, and lack of knowledge among patients and primary care providers (PCPs). The advent of multigene panel testing (MGPT) and rapidly evolving field of cancer genetics have added to the complexity of interpreting genetic test results. To address genetic testing knowledge gaps, the investigators have developed online decision support tools, BNAV (Breast cancer risk NAVigation) for PCPs and RealRisks for patients, which have been rigorously tested among racially/ethnically diverse women in randomized controlled trials (RCTs).
To build upon this prior work, the investigators propose the ELISABETH (Electronic health record [EHR]-based implementation strategies and decision support for hereditary breast and ovarian cancer genetic testing among multiethnic women) study.
- Conditions
- Breast Cancer, Ovarian Cancer, Hereditary Cancer Syndrome
- Being tested
- ELISABETH Evidence-Informed Program (EIP)
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISABETH Evidence-Informed Program (EIP)Behavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| ELISABETH Evidence-Informed Program (EIP) | Experimental | 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. Receives: Behavioral: ELISABETH Evidence-Informed Program (EIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Testing Knowledge
Change in hereditary breast and ovarian cancer (HBOC) genetic testing knowledge, assessed using an 11-item true/false questionnaire evaluating knowledge of HBOC genetic testing. Total score ranges from 0 to 11, with higher scores indicating greater genetic testing knowledge
Measured: Baseline to 1 month
Secondary outcomes (9)
Threat Beliefs
Perceived susceptibility will be assessed using a 3-item measure evaluating perceived risk of developing cancer, likelihood that cancer is hereditary in the family, and risk for healthy relatives. Responses are expressed as percent risk estimates. Higher scores indicate greater perceived susceptibility.
Measured: at baseline, 1 month, and 6 months
Uncertainty
Uncertainty regarding genetic testing will be assessed using a 3-item scale adapted from the Multidimensional Impact of Cancer Risk Assessment (MICRA). The full scale ranges from 0 to 5. Higher scores indicate greater uncertainty related to genetic testing and results.
Measured: 1 month and 6 months
Cancer-related distress assessed using the 15-item Impact of Event Scale (IES)
The measure evaluates intrusive thoughts and avoidant thinking related to genetic testing. The full scale ranges from 0 to 5. Higher scores indicate greater cancer-specific distress.
Measured: Baseline, 1 month, and 6 months
Decisional Conflict
The Decisional Conflict Scale measures uncertainty regarding the decision to undergo genetic testing and receive results. The full scale ranges from 0 to 100. Higher scores indicate greater decisional conflict.
Measured: 1 month and 6 months
Attitudes Toward Receiving Genetic Test Results
Attitudes regarding receipt of genetic test results will be assessed using a 6-item scale. Responses are scored from 1 to 7 and averaged to create a total score. Higher scores indicate more favorable attitudes toward receiving genetic test results.
Measured: Baseline and 1 month
Understanding Genetic Test Results
Self-reported understanding of genetic test results, including positive, likely positive, variant of uncertain significance, negative, or unclear results. The outcome will be reported as proportion of participants who correctly understand their genetic test results.
Measured: 6 months
Utilization of Genetic Test Results
Proportion of participants reporting that genetic test results influenced decisions regarding prophylactic surgery, chemoprevention, additional cancer screening, or adoption of risk-reducing behaviors.
Measured: 6 months
Behavioral Intention
Behavioral intention regarding genetic testing and risk management behaviors, assessed through participant-reported intentions to engage in recommended preventive actions during the next 12 months. The full scale ranges from 1 to 5. Higher scores indicate stronger behavioral intention.
Measured: 6 months
Family Communication
Proportion of participants who communicate genetic test results to family members and discuss family genetic testing and/or risk-reducing behaviors.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Sep 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Katherine D. Crew, Columbia University
- Investigators
- Katherine Crew, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876349
- Sponsor's protocol ID
- AAAV5822
- Other IDs
- UG3CA297490
- Acronym
- ELISABETH
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Health Record-based Implementation Strategies and Decision Support for Hereditary Breast and Ovarian Cancer (HBOC) Genetic Testing Among Heterogeneous Women (ELISABETH) Pragmatic Trial
- ClinicalTrials.gov ID
- NCT07876349
- Acronym / sponsor ID
- ELISABETH / AAAV5822
- Conditions
- Breast Cancer, Ovarian Cancer, Hereditary Cancer Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
About 5-10% of breast cancers and 10-15% of ovarian cancers are attributed to pathogenic variants (PVs) in cancer predisposition genes, such as BRCA1 and BRCA2. Identifying women with PVs in hereditary breast and ovarian cancer (HBOC) genes can inform risk management strategies, such as enhanced cancer screening, risk-reducing surgeries, and chemoprevention, which have been shown to reduce cancer incidence and mortality. There is significant underutilization of HBOC genetic testing in primary care, with women of color and lower socioeconomic status less likely to receive testing compared to their White or higher income counterparts. Barriers include lack of systematic family history intake, limited access to genetic counseling services, and lack of knowledge among patients and primary care providers (PCPs). The advent of multigene panel testing (MGPT) and rapidly evolving field of cancer genetics have added to the complexity of interpreting genetic test results. To address genetic testing knowledge gaps, the investigators have developed online decision support tools, BNAV (Breast cancer risk NAVigation) for PCPs and RealRisks for patients, which have been rigorously tested among racially/ethnically diverse women in randomized controlled trials (RCTs).
To build upon this prior work, the investigators propose the ELISABETH (Electronic health record [EHR]-based implementation strategies and decision support for hereditary breast and ovarian cancer genetic testing among multiethnic women) study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELISABETH Evidence-Informed Program (EIP) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who previously participated in the development studies for RealRisks and BNAV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | ELISABETH Evidence-Informed Program (EIP) |
Primary outcome
Genetic Testing Knowledge
Time frame: Baseline to 1 month
Change in hereditary breast and ovarian cancer (HBOC) genetic testing knowledge, assessed using an 11-item true/false questionnaire evaluating knowledge of HBOC genetic testing. Total score ranges from 0 to 11, with higher scores indicating greater genetic testing knowledge
9 secondary outcomes
Threat Beliefs
Time frame: at baseline, 1 month, and 6 months
Uncertainty
Time frame: 1 month and 6 months
Cancer-related distress assessed using the 15-item Impact of Event Scale (IES)
Time frame: Baseline, 1 month, and 6 months
Decisional Conflict
Time frame: 1 month and 6 months
Attitudes Toward Receiving Genetic Test Results
Time frame: Baseline and 1 month
Understanding Genetic Test Results
Time frame: 6 months
Utilization of Genetic Test Results
Time frame: 6 months
Behavioral Intention
Time frame: 6 months
Family Communication
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Crew, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISABETH Evidence-Informed Program (EIP) in people with Breast Cancer and Ovarian Cancer, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Nurse Navigator (212-342-5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Testing Knowledge (time frame: Baseline to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.