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

DiNucci, Anna; Henrikson, Nora B.; Jonas, M. Cabell; Basra, Sundeep; Blasi, Paula; Brown, Jennifer; Esplin, Edward D.; Hassen, Dina; Hao, Jing; Hu, Yirui; Klinger, Tracey; Ladd, Ilene; Leppig, Kathleen; Lewis, Meredith; Meyer, Michelle; Ney, Steven; Ramaprasan, Arvind; Romagnoli, Katrina; Salvati, Zachary; Scrol, Aaron; Schwiter, Rachel; Sheridan, Leigh; Somasundaram, Brinda; Suwannarat, Pim; Wagner, Jennifer K.; Rahm, Alanna K.

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.