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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ovarian Cancer; Genetic Predisposition to Disease; Breast Cancer Female; Hereditary Diseases; Gene Mutation-Related Cancer; Hereditary Breast and Ovarian Cancer; Hereditary Cancer Syndrome
• Intervention / Treatment: Other: Sequential EHR Communications

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 Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Symecko, MPH; Phone Number: 215-662-2770; Email: hsymecko@pennmedicine.upenn.edu
• Study Contact Backup: Name: Catherine Wolfe, BA; Phone Number: 215-360-0422; Email: catherine.wolfe@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania
      • Contact: Heather Symecko, MPH; Phone Number: 215-662-2770; Email: hsymecko@pennmedicine.upenn.edu
      • Contact: Catherine Wolfe, BA; Phone Number: 215-360-0422; Email: catherine.wolfe@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sequential Communications; 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.

Other: Sequential EHR Communications; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Genetic Counseling Appointments Completed Following 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.	Within six months of MPM delivery
Number of Genetic Counseling Appointments Completed Following 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.	Within six months of provider nudge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open Rate of 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.	Within one month of receiving MPM
Response Rate of Way To Health 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.	Within one month of receiving text

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Signed Referrals	The total number of referrals signed by the patient's Ob/Gyn provider for genetic counseling and testing.	Within one month of receiving referral

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine

Publications and helpful links

General Publications

• Srivastava SK, Ahmad A, Miree O, Patel GK, Singh S, Rocconi RP, Singh AP. Racial health disparities in ovarian cancer: not just black and white. J Ovarian Res. 2017 Sep 21;10(1):58. doi: 10.1186/s13048-017-0355-y.
• Menon U, Gentry-Maharaj A, Burnell M, Singh N, Ryan A, Karpinskyj C, Carlino G, Taylor J, Massingham SK, Raikou M, Kalsi JK, Woolas R, Manchanda R, Arora R, Casey L, Dawnay A, Dobbs S, Leeson S, Mould T, Seif MW, Sharma A, Williamson K, Liu Y, Fallowfield L, McGuire AJ, Campbell S, Skates SJ, Jacobs IJ, Parmar M. Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial. Lancet. 2021 Jun 5;397(10290):2182-2193. doi: 10.1016/S0140-6736(21)00731-5. Epub 2021 May 12.
• Reid S, Cadiz S, Pal T. Disparities in Genetic Testing and Care among Black women with Hereditary Breast Cancer. Curr Breast Cancer Rep. 2020 Sep;12(3):125-131. doi: 10.1007/s12609-020-00364-1. Epub 2020 May 19.
• Jatoi I, Sung H, Jemal A. The Emergence of the Racial Disparity in U.S. Breast-Cancer Mortality. N Engl J Med. 2022 Jun 23;386(25):2349-2352. doi: 10.1056/NEJMp2200244. Epub 2022 Jun 18. No abstract available.
• Domchek SM, Robson ME. Update on Genetic Testing in Gynecologic Cancer. J Clin Oncol. 2019 Sep 20;37(27):2501-2509. doi: 10.1200/JCO.19.00363. Epub 2019 Aug 12. No abstract available.
• Daly MB, Pal T, Berry MP, Buys SS, Dickson P, Domchek SM, Elkhanany A, Friedman S, Goggins M, Hutton ML; CGC; Karlan BY, Khan S, Klein C, Kohlmann W; CGC; Kurian AW, Laronga C, Litton JK, Mak JS; LCGC; Menendez CS, Merajver SD, Norquist BS, Offit K, Pederson HJ, Reiser G; CGC; Senter-Jamieson L; CGC; Shannon KM, Shatsky R, Visvanathan K, Weitzel JN, Wick MJ, Wisinski KB, Yurgelun MB, Darlow SD, Dwyer MA. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Jan 6;19(1):77-102. doi: 10.6004/jnccn.2021.0001.
• Smith-Uffen M, Bartley N, Davies G, Best M. Motivations and barriers to pursue cancer genomic testing: A systematic review. Patient Educ Couns. 2021 Jun;104(6):1325-1334. doi: 10.1016/j.pec.2020.12.024. Epub 2020 Dec 25.
• Kurian AW, Ward KC, Howlader N, Deapen D, Hamilton AS, Mariotto A, Miller D, Penberthy LS, Katz SJ. Genetic Testing and Results in a Population-Based Cohort of Breast Cancer Patients and Ovarian Cancer Patients. J Clin Oncol. 2019 May 20;37(15):1305-1315. doi: 10.1200/JCO.18.01854. Epub 2019 Apr 9.
• McBride CM, Pathak S, Johnson CE, Alberg AJ, Bandera EV, Barnholtz-Sloan JS, Bondy ML, Cote ML, Moorman PG, Peres LC, Peters ES, Schwartz AG, Terry PD, Schildkraut JM. Psychosocial factors associated with genetic testing status among African American women with ovarian cancer: Results from the African American Cancer Epidemiology Study. Cancer. 2022 Mar 15;128(6):1252-1259. doi: 10.1002/cncr.34053. Epub 2021 Dec 9.
• Hamilton JG, Symecko H, Spielman K, Breen K, Mueller R, Catchings A, Trottier M, Salo-Mullen EE, Shah I, Arutyunova A, Batson M, Gebert R, Pundock S, Schofield E, Offit K, Stadler ZK, Cadoo K, Carlo MI, Narayan V, Reiss KA, Robson ME, Domchek SM. Uptake and acceptability of a mainstreaming model of hereditary cancer multigene panel testing among patients with ovarian, pancreatic, and prostate cancer. Genet Med. 2021 Nov;23(11):2105-2113. doi: 10.1038/s41436-021-01262-2. Epub 2021 Jul 13.
• Lau-Min KS, Guerra CE, Nathanson KL, Bekelman JE. From Race-Based to Precision Oncology: Leveraging Behavioral Economics and the Electronic Health Record to Advance Health Equity in Cancer Care. JCO Precis Oncol. 2021 Feb 17;5:PO.20.00418. doi: 10.1200/PO.20.00418. eCollection 2021. No abstract available.
• Kukafka R, Pan S, Silverman T, Zhang T, Chung WK, Terry MB, Fleck E, Younge RG, Trivedi MS, McGuinness JE, He T, Dimond J, Crew KD. Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2222092. doi: 10.1001/jamanetworkopen.2022.22092.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: genetics; breast cancer; genetic testing; ovarian cancer; intervention; female; text message; germline genetic testing; genetic counseling; nudge; NCCN guidelines; hereditary cancer; sequential intervention; message-based intervention; diverse patient population; digital health technology; EHR based intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Breast Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Disease Susceptibility; Carcinoma, Ovarian Epithelial; Genetic Diseases, Inborn; Genetic Predisposition to Disease; Hereditary Breast and Ovarian Cancer Syndrome; Neoplastic Syndromes, Hereditary
• Other Study ID Numbers: 25922; 851980 (Other Identifier: IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No