Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

Not Applicable

• Conditions: Gene Mutation-Related Cancer; Genetic Predisposition to Disease; Breast Cancer Female; Ovarian Cancer; Hereditary Breast and Ovarian Cancer; Hereditary Diseases; Hereditary Cancer Syndrome

• Registration Number: NCT05721326
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Germline genetic testing is recommended by the National Cancer Center Network (NCCN) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. Recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. EHR-based algorithms will be used to identify patients of two Penn Medicine Ob/Gyn practices for whom genetic testing is recommended based on NCCN guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. The ACC Electronic Phenotyping Core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. The aims are:

1. Identification of at-risk populations through electronic health record (EHR) searches followed by patient nudges (MPM and then Way To Health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at Dickens Center and Penn Medicine Radnor.

2. In patients who have not responded to patient nudges (Aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at Dickens Center and Penn Medicine Radnor (Aim 2).

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-10
• Study Start: 2023-05-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. Patients with serous ovarian cancer diagnosed more than two years prior to study contact
2. Patients with breast cancer diagnosed at <50 years of age more than two years prior to study contact
3. Patients with triple negative breast cancer diagnosed more than two years prior to study contact
4. Unaffected individuals reporting a family history of ovarian cancer
5. Unaffected individuals reporting a family history of male breast cancer
6. Unaffected individuals reporting a family history of breast cancer <50 years

Exclusion Criteria

1. Patients who have previously received genetic counseling and/or testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of Genetic Counseling Appointments Completed Following Provider Nudge	Within six months of provider nudge	Scheduling and completion of genetic counseling appointments will be monitored through EHR. The provider nudge will be delivered as a Best Practice Alert (BPA) upon opening the patient's chart.
Number of Genetic Counseling Appointments Completed Following MPM Delivery	Within six months of MPM delivery	Scheduling and completion of genetic counseling appointments will be monitored through EHR. MPM stands for MyPennMedicine message which will be sent directly to the patient through the medical record.

Secondary Outcome Measures

Name	Time	Method
Response Rate of Way To Health text	Within one month of receiving text	The proportion of eligible participants who respond to a text message invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent a Way To Health (WTH) text.
Open Rate of MPM	Within one month of receiving MPM	The proportion of eligible participants who open the invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent an MPM.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States