CClinicalTrials.gg
Enrolling by invitationNCT07053813CARE-HCSUpdated Feb 27, 2026

Applying Population Management Best Practices to Preventative Genomic Medicine Trial

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

Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Neoplastic Syndromes, Hereditary

Keywords

  • hereditary cancer syndrome
  • pragmatic trial
  • population management
  • care coordination
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In context

Neoplastic Syndromes, Hereditary

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinically actionable variant in at least one high penetrance cancer-related gene
  • Age- and sex- eligible for guideline indicated risk management
  • Remains eligible for risk management, given personal cancer and surgical history

Exclusion criteria

Exclusion Criteria:

  • Previously opted out of research
  • Previously opted out of genetic research
  • On hospice or palliative care
  • Has advanced dementia or severe cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (estimated)

Study arms

  • No intervention
    Usual care

    No intervention

  • Experimental
    Web resources

    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

  • Experimental
    Personalized outreach

    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

Interventions

  • BehavioralWeb resources

    Mailed educational resources through portal and USPS mail

  • BehavioralPersonalized outreach

    Phone call to discuss due and overdue screening and other personalized risk management recommendations

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What researchers measure

Primary outcomes

  1. Proportion time covered

    Proportion time covered by recommended cancer screening

    Time frame: 12 months following randomization

Secondary outcomes

  1. Risk reducing surgery

    Proportion completing one or more risk reducing surgery

    Time frame: 12 months following randomization

07

Study locations

2 sites
  • Denver Health
    Denver, Colorado 80204, United States
  • Kaiser Northwest
    Portland, Oregon 97227, United States
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07053813
Lead sponsor
University of Washington
Collaborators
National Human Genome Research Institute (NHGRI)
Responsible party
Sarah Knerr (Assistant Professor, Health Systems and Population Health, University of Washington) — Principal investigator
First posted
Jul 8, 2025
Start date
Jul 1, 2025
Primary completion
Jul 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Feb 27, 2026

Study contacts

Sarah Knerr, PhD, MPH
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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