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Patient and Family Preferences on Health System-Led Direct Contact for Cascade Screening
 
 
Study Protocol

Feasibility and Assessment of a Cascade Traceback Screening Program (FACTS): Protocol for a Multisite Study to Implement and Assess an Ovarian Cancer Traceback Cascade Testing Program

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Mid-Atlantic Permanente Research Institute, 2101 E. Jefferson St, Rockville, MD 20852, USA
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Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA
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Invitae Corporation, 1400 16th St, San Francisco, CA 94103, USA
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Geisinger Department of Population Health Sciences, 100 N. Academy Ave, Danville, PA 17822, USA
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Geisinger Department of Epidemiology and Health Services Research, 100 N. Academy Ave, Danville, PA 17822, USA
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Geisinger Genomic Medicine Institute, 100 N. Academy Ave, Danville, PA 17822, USA
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Geisinger, Center for Translational Bioethics & Health Care Policy, 100 N. Academy Ave, Danville, PA 17822, USA
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Author to whom correspondence should be addressed.
Academic Editor: Gesche Jürgens
J. Pers. Med. 2021, 11(6), 543; https://doi.org/10.3390/jpm11060543
Received: 30 April 2021 / Revised: 6 June 2021 / Accepted: 8 June 2021 / Published: 11 June 2021
(This article belongs to the Special Issue Cancer Genetics and Genomics Research)
Ovarian cancer (OVCA) patients may carry genes conferring cancer risk to biological family; however, fewer than one-quarter of patients receive genetic testing. “Traceback” cascade testing —outreach to potential probands and relatives—is a possible solution. This paper outlines a funded study (U01 CA240747-01A1) seeking to determine a Traceback program’s feasibility, acceptability, effectiveness, and costs. This is a multisite prospective observational feasibility study across three integrated health systems. Informed by the Conceptual Model for Implementation Research, we will outline, implement, and evaluate the outcomes of an OVCA Traceback program. We will use standard legal research methodology to review genetic privacy statutes; engage key stakeholders in qualitative interviews to design communication strategies; employ descriptive statistics and regression analyses to evaluate the site differences in genetic testing and the OVCA Traceback testing; and assess program outcomes at the proband, family member, provider, system, and population levels. This study aims to determine a Traceback program’s feasibility and acceptability in a real-world context. It will account for the myriad factors affecting implementation, including legal issues, organizational- and individual-level barriers and facilitators, communication issues, and program costs. Project results will inform how health care providers and systems can develop effective, practical, and sustainable Traceback programs. View Full-Text
Keywords: implementation; implementation research; ovarian cancer; traceback cascade testing program; genetic testing; micro-costing; HIPAA implementation; implementation research; ovarian cancer; traceback cascade testing program; genetic testing; micro-costing; HIPAA
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MDPI and ACS Style

DiNucci, A.; Henrikson, N.B.; Jonas, M.C.; Basra, S.; Blasi, P.; Brown, J.; Esplin, E.D.; Hassen, D.; Hao, J.; Hu, Y.; Klinger, T.; Ladd, I.; Leppig, K.; Lewis, M.; Meyer, M.; Ney, S.; Ramaprasan, A.; Romagnoli, K.; Salvati, Z.; Scrol, A.; Schwiter, R.; Sheridan, L.; Somasundaram, B.; Suwannarat, P.; Wagner, J.K.; Rahm, A.K. Feasibility and Assessment of a Cascade Traceback Screening Program (FACTS): Protocol for a Multisite Study to Implement and Assess an Ovarian Cancer Traceback Cascade Testing Program. J. Pers. Med. 2021, 11, 543. https://doi.org/10.3390/jpm11060543

AMA Style

DiNucci A, Henrikson NB, Jonas MC, Basra S, Blasi P, Brown J, Esplin ED, Hassen D, Hao J, Hu Y, Klinger T, Ladd I, Leppig K, Lewis M, Meyer M, Ney S, Ramaprasan A, Romagnoli K, Salvati Z, Scrol A, Schwiter R, Sheridan L, Somasundaram B, Suwannarat P, Wagner JK, Rahm AK. Feasibility and Assessment of a Cascade Traceback Screening Program (FACTS): Protocol for a Multisite Study to Implement and Assess an Ovarian Cancer Traceback Cascade Testing Program. Journal of Personalized Medicine. 2021; 11(6):543. https://doi.org/10.3390/jpm11060543

Chicago/Turabian Style

DiNucci, Anna, Nora B. Henrikson, M. Cabell Jonas, Sundeep Basra, Paula Blasi, Jennifer Brown, Edward D. Esplin, Dina Hassen, Jing Hao, Yirui Hu, Tracey Klinger, Ilene Ladd, Kathleen Leppig, Meredith Lewis, Michelle Meyer, Steven Ney, Arvind Ramaprasan, Katrina Romagnoli, Zachary Salvati, Aaron Scrol, Rachel Schwiter, Leigh Sheridan, Brinda Somasundaram, Pim Suwannarat, Jennifer K. Wagner, and Alanna K. Rahm. 2021. "Feasibility and Assessment of a Cascade Traceback Screening Program (FACTS): Protocol for a Multisite Study to Implement and Assess an Ovarian Cancer Traceback Cascade Testing Program" Journal of Personalized Medicine 11, no. 6: 543. https://doi.org/10.3390/jpm11060543

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