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

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

NCT ID: NCT05721326

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

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hereditary Breast and Ovarian Cancer Syndrome
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Disease Susceptibility
Genetic Predisposition to Disease

Conditions: Keywords:
NCCN guidelines
genetic testing
hereditary cancer
breast cancer
ovarian cancer
intervention
sequential intervention
message-based intervention
text message
diverse patient population
genetics
female
digital health technology
germline genetic testing
nudge
EHR based intervention
genetic counseling

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Intervention model description: Eligible patients will be sent a message through the patient portal to encourage genetic counseling and testing. If the patient does not respond, they will be sent a text message. Should there be no response, the patient's clinician will receive a nudge

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Sequential EHR Communications
Description: 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.
Arm group label: Sequential Communications

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).

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 25 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: Abramson Cancer Center of the University of Pennsylvania

Address:
City: Philadelphia
Zip: 19104
Country: United States

Start date: May 1, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Abramson Cancer Center at Penn Medicine
Agency class: Other

Source: Abramson Cancer Center at Penn Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05721326