Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition
NCT ID: NCT05721326
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1330 participants
INTERVENTIONAL
2023-05-01
2025-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
25 Years
100 Years
FEMALE
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
Other Identifiers
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851980
Identifier Type: OTHER
Identifier Source: secondary_id
25922
Identifier Type: -
Identifier Source: org_study_id
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