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OpenTrials
Completed

NCT Number: NCT05721326

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

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.

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Key information

Conditions

Genetic Predisposition to Disease Adnexal Diseases Breast Cancer Female Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disease Susceptibility Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gene Mutation-Related Cancer Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Hereditary Breast and Ovarian Cancer Syndrome Hereditary Cancer Syndrome Hereditary Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

25 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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:

  • 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.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with serous ovarian cancer diagnosed more than two years prior to study contact
  • Patients with breast cancer diagnosed at <50 years of age more than two years prior to study contact
  • Patients with triple negative breast cancer diagnosed more than two years prior to study contact
  • Unaffected individuals reporting a family history of ovarian cancer
  • Unaffected individuals reporting a family history of male breast cancer
  • Unaffected individuals reporting a family history of breast cancer <50 years

Exclusion criteria

  • Patients who have previously received genetic counseling and/or testing

Treatment and study plan

Sequential EHR Communications

Other

The intervention includes 3 message types: an EHR message, followed by a text message, followed by physician nudge. Each subsequent type will be activated if the previous type does not yield a response.

Primary outcomes

  1. Number of Genetic Counseling Appointments Completed Following MPM Delivery

    Time frame: 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.

  2. Number of Genetic Counseling Appointments Completed Following Provider Nudge

    Time frame: 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.

Secondary outcomes

  1. Open Rate of MPM

    Time frame: 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.

  2. Response Rate of Way To Health text

    Time frame: 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.

Other outcomes

  1. Number of Signed Referrals

    Time frame: Within one month of receiving referral

    The total number of referrals signed by the patient's Ob/Gyn provider for genetic counseling and testing.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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