An interventional study of Web resources and Personalized outreach in Neoplastic Syndromes, Hereditary, sponsored by University of Washington. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
Preventive genomic medicine, particularly identification of individuals with inherited cancer risk, can improve longevity and quality of life, yet adherence to risk management following cancer genomic testing is poor. The proposed research refines and evaluates two highly scalable population management interventions, web resources and personalized outreach, designed to improve access and use of recommended risk management following cancer genetic testing. Research activities will be conducted in a vertically integrated health system and federally qualified health center and will address post-testing quality and patient safety concerns that are minimizing patient benefit and slowing investments in real world genomic medicine implementation.
Preventive genomic medicine, particularly identification of individuals with inherited cancer risk, provides health systems with the opportunity to improve longevity and quality of life for their patients. The ability to uncover substantially elevated risk of disease through genomic testing, act to reduce that risk, and improve outcomes while lowering costs has been the longstanding promise of genomic medicine. In the case of inherited cancer, however, adherence to recommended risk management following genomic testing is low. Further, our pilot data suggests that health systems are reluctant to expand cancer genomic testing without a clearer idea of how to manage tested patients over time. Our goal in this application is to address this roadblock to genomic medicine implementation. Specifically, we will demonstrate the benefits that adopting population management interventions following genomic testing can provide health systems, using hereditary cancer as a case example. We will revise and rigorously evaluate two population management interventions (web resources and personalized outreach) that improve timely patient outreach and end-to-end tracking without burdening providers. Web resources is a low-touch intervention that links patients with existing educational resources. Personalized outreach is a high-touch intervention that connects patients with a dedicated care manager to discuss risk management and provide care reminders.
Both interventions are highly scalable and mirror population management programs that health systems have used to support cancer screening, diabetes management, and other evidence-based care for decades. We will compare web resources and personalized outreach to usual care in a pragmatic hybrid type-1 randomized trial that engages patients captured in hereditary cancer registries within two health systems, Kaiser Permanente Northwest (KPNW) and Denver Health (DH). KPNW is a vertically integrated health system and DH is a federally qualified health center, providing two highly unique evaluation settings. Our primary effectiveness outcome is adherence to recommended cancer screening over one year. We will collect secondary implementation outcomes, including the acceptability, appropriateness, feasibility, sustainability, and costs of high- and low-touch intervention approaches. By providing clinical champions with essential data and tools to select and implement population management interventions that address critical gaps in post-testing quality and patient safety, this innovative project will advance preventive genomic medicine.
44 studies on the registry are indexed under Neoplastic Syndromes, Hereditary; 23 are open to participants now.
This study's planned enrollment of 900 is above the median of 550 across 21 interventional studies indexed under Neoplastic Syndromes, Hereditary.
Browse Neoplastic Syndromes, Hereditary studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No intervention
Individuals randomized to web resources will be sent materials refined in Aim 1 (via patient portal and USPS mail) within 1-2 weeks after their birthday. Messages will be sent in English or preferred language noted in the EHR.
Behavioral: Web resources
Individuals randomized to personalized outreach will be contacted by the care coordinator in their birthday month for a brief phone call discussing due and overdue screening. The coordinator will attempt to contact patients up to 3 times to complete the phone conversation before considering them opting out of the intervention. If needed, the coordinator can place orders and pending referrals for PCP signature.
Behavioral: Personalized outreach
Mailed educational resources through portal and USPS mail
Phone call to discuss due and overdue screening and other personalized risk management recommendations
Proportion time covered
Proportion time covered by recommended cancer screening
Time frame: 12 months following randomization
Risk reducing surgery
Proportion completing one or more risk reducing surgery
Time frame: 12 months following randomization
Plan to share: Yes — The University of Washington will create public use de-identified datasets of clinical trial data with an accompanying data dictionary, codes, and other documentation relevant to use.
Supporting information: Study protocol, Sap
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Neoplastic Syndromes, Hereditary→
University of Washington