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

3000 Participants Needed

Trial Summary

What is the purpose of this trial?

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 is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.

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 data supports the effectiveness of the treatment Sequential EHR Communications for breast and ovarian cancer genetic testing?

Research shows that using electronic health records (EHRs) to streamline referrals for genetic testing in ovarian cancer patients can improve the rate of referrals and testing completion. This suggests that similar EHR-based interventions could be effective in increasing genetic testing for breast and ovarian cancer. ^{1 2 3 4 5}

Is EHR-based intervention for genetic testing safe for humans?

The research does not provide specific safety data for EHR-based interventions for genetic testing, but it focuses on improving documentation and referral processes in electronic health records, which are generally safe as they involve administrative and informational improvements rather than direct medical treatments. ^{3 4 6 7 8}

How does the treatment Sequential EHR Communications differ from other treatments for breast and ovarian cancer genetic testing?

Sequential EHR Communications is unique because it leverages electronic health records (EHR) to improve the referral process for genetic testing, ensuring that more patients who meet the criteria for genetic risk assessment are identified and referred. This approach addresses the underutilization of genetic testing by systematically capturing and using risk factor information already present in EHRs, which is not a standard practice in traditional treatments. ^{3 4 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Healthcare professionals' perspectives on implementation of universal tumor DNA testing in ovarian cancer patients: multidisciplinary focus groups. [2023]

2. Denmark pubmed.ncbi.nlm.nih.gov

Patterns and predictors of genetic referral among ovarian cancer patients at a National Cancer Institute-Comprehensive Cancer Center. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Improving referral for genetic risk assessment in ovarian cancer using an electronic medical record system. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation of a quality improvement project for universal genetic testing in women with ovarian cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Genetic risk assessment for women with epithelial ovarian cancer: referral patterns and outcomes in a university gynecologic oncology clinic. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Incomplete Penetrance of Population-Based Genetic Screening Results in Electronic Health Record. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Electronic medical record documentation of germline genetic evaluations in patients with ovarian cancer. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Electronic health records contain dispersed risk factor information that could be used to prevent breast and ovarian cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Adherence to Recommended Risk Management among Unaffected Women with a BRCA Mutation. [2018]