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

NCT05721326 | Completed

• 2 other identifiers: 25922851980
• Study Type: interventional
• Target: 1,330
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Open Rate of MPM

  Within one month of receiving MPM

• Response Rate of Way To Health text

  Within one month of receiving text

Other Outcomes (1)

• Number of Signed Referrals

  Within one month of receiving referral

Study Arms (1)

Sequential Communications

EXPERIMENTAL

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

Interventions

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.

Sequential Communications

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (13)

• 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.

  PMID: 28931403 BACKGROUND

• 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.

  PMID: 33991479 BACKGROUND

• 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.

  PMID: 33603954 BACKGROUND

• 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.

  PMID: 35713541 BACKGROUND

• 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.

  PMID: 31403865 BACKGROUND

• 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.

  PMID: 33406487 BACKGROUND

• 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.

  PMID: 33390305 BACKGROUND

• 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.

  PMID: 30964716 BACKGROUND

• 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.

  PMID: 34882782 BACKGROUND

• 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.

  PMID: 34257420 BACKGROUND

• 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.

  PMID: 34250405 BACKGROUND

• 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.

  PMID: 35849397 BACKGROUND

• Symecko H, Schnoll R, Beidas RS, Bekelman JE, Blumenthal D, Bauer AM, Gabriel P, Boisseau L, Doucette A, Powers J, Cappadocia J, McKenna DB, Richardville R, Cuff L, Offer R, Clement EG, Buttenheim AM, Asch DA, Rendle KA, Shelton RC, Fayanju OM, Wileyto EP, Plag M, Ware S, Shulman LN, Nathanson KL, Domchek SM. Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices. Implement Sci. 2023 Nov 6;18(1):57. doi: 10.1186/s13012-023-01308-w.

  PMID: 37932730 DERIVED

MeSH Terms

Conditions

Genetic Predisposition to Disease; Ovarian Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Breast Neoplasms

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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\&#39;s clinician will receive a nudge

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 10, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)