EHR-Based Interventions for Breast and Ovarian Cancer Genetic Testing

Overseen By Catherine Wolfe, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Previous genetic counseling/testing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to boost genetic testing for individuals at risk of breast and ovarian cancer. The researchers seek to determine which communication method, including Sequential EHR Communications (a method using electronic health records), most effectively encourages testing. Participants will receive essential genetic testing and counseling, potentially leading to life-saving screenings. The trial seeks individuals with a personal or family history of specific cancers, such as ovarian or early-onset breast cancer. Those who have already undergone genetic testing or counseling are not eligible. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance genetic testing outreach and potentially save lives.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these EHR-based interventions are safe?

Research shows that using electronic health records (EHR) to encourage genetic testing for breast and ovarian cancer risk is generally safe. This approach includes sending messages through patient portals, text messages, and alerts to doctors.

Studies have found that patients and doctors receive these EHR messages well, and no major problems have arisen from their use. The goal is to raise awareness and encourage follow-up on genetic testing.

Overall, using EHRs in this way poses low risk and serves as a useful tool for improving healthcare outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to encourage genetic testing for breast and ovarian cancer using electronic health records (EHR). Unlike traditional methods that rely on patients or doctors to initiate testing discussions, this approach uses a sequence of automated digital nudges. The first step is a direct message to patients through the MyPennMedicine portal, followed by a text via the Way To Health app if there's no response, and finally, a reminder to the patient's physician. This proactive strategy could enhance early detection by streamlining communication and ensuring that important genetic testing opportunities aren't missed.

What evidence suggests that this intervention is effective for increasing genetic testing in breast and ovarian cancer?

Studies have shown that electronic health records (EHR) can help doctors identify patients who need genetic testing for breast and ovarian cancer risk. Research indicates that when doctors use EHRs to refer patients to genetic counseling, they gather more important family history details, leading to better identification of those who might benefit from genetic testing. In one study with 56 women, those who visited a genetics clinic after an EHR reminder understood their cancer risk better. This trial will test Sequential EHR Communications, which involves a series of communications to patients and their physicians. Overall, using EHR communications increases the likelihood of patients receiving the genetic tests they need. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with a family history of breast or ovarian cancer, especially if diagnosed before age 50, and those with specific types of these cancers diagnosed over two years ago. It's not open to anyone who has already had genetic counseling or testing.

Inclusion Criteria

I was diagnosed with serous ovarian cancer over two years ago.

My family has a history of breast cancer before age 50.

I was diagnosed with breast cancer before turning 50 and it has been over two years.

Exclusion Criteria

I have undergone genetic counseling or testing before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive sequential EHR-based interventions to increase genetic testing uptake, including direct messages, text messages, and provider nudges

6 months

Follow-up

Participants are monitored for the completion of genetic counseling appointments and response to interventions

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Sequential EHR Communications

Trial Overview The study tests different ways to communicate through electronic health records (EHR) to see which method increases the rate at which people get genetic testing for breast and ovarian cancer predisposition.

How Is the Trial Designed?

Group I: Sequential Communications Experimental Treatment 1 Intervention

This sequential arm contains three types of communication to be employed following non-response to the previous type. The initial communication will be a direct message to the patient via the MyPennMedicine. The subsequent message will be sent as a text via the Way To Health app(lication). The final communication will be a nudge to the patient's physician which will send upon opening the patient's chart and will remain as a flag thereafter.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05721326

Sequential EHR Based Interventions to Increase Genetic ... The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10629034/

Protocol to evaluate sequential electronic health record ... Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk

3. brotmanbaty.org brotmanbaty.org/news/study-of-electronic-health-records-demonstrates-value-of-data-in-referring

Study of Electronic Health Records Demonstrates Value ... This study of 56 women quantitatively demonstrates the value of a genetics clinic visit by improved identification of key family history components.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794299

Patient and Clinician Decision Support to Increase Genetic ... Secondary outcomes were genetic testing uptake at 6 and 24 months, decision-making measures (perceived breast cancer risk, breast cancer worry, ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13408-x

The breast cancer genetic testing experience: probing the ... Of the 22 women interviewed, 11 (50%) had positive GT results, 2 (9.1%) with a BRCA1/2 PV, and 9 (40.9%) with variants of uncertain significance ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37932730

Protocol to evaluate sequential electronic health record-based ... Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across ...

7. cancer.jmir.org cancer.jmir.org/2025/1/e58657

Understanding and Addressing Challenges ... - JMIR Cancer Extraction of electronic health record data using fast healthcare interoperability resources for automated breast cancer risk assessment.

8. medpro.com medpro.com/cs-ehr-oversight-delay-diagnosis-ovarian-cancer

Case Study: Oversight in Electronic Health Record Causes ... A simple oversight of critical information on a report scanned into the OB/GYN practice's EHR system led to a diagnostic error and a poor patient outcome.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04166240

Measuring and Improving the Safety of Test Result Follow-Up The goal of this study is to develop and evaluate a new program for surveillance and improvement of test results-related diagnostic safety.