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Neoplastic Syndromes, HereditaryCARE-HCSNCT07053813

Applying Population Management Best Practices to Preventative Genomic Medicine Trial

A study testing Web resources and Personalized outreach in people with Neoplastic Syndromes, Hereditary, run by University of Washington at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplastic Syndromes, Hereditary
What is being tested?
Web resources and Personalized outreach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
2 sitesUnited States
Study dates
1 Jul 2025to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Denver Health

    Denver, Colorado, 80204

  • Kaiser Northwest

    Portland, Oregon, 97227

Other trials in United States

About this study

Official title: Applying Population Management Best Practices to Preventive Genomic Medicine

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.

Being tested
Web resources, Personalized outreach
Keywords
hereditary cancer syndrome, pragmatic trial, population management, care coordination
Medical subject headings
Neoplastic Syndromes, Hereditary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web resourcesBehavioural

    Mailed educational resources through portal and USPS mail

  • Personalized outreachBehavioural

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

Study groups in NCT07053813
Study groupRoleWhat they receive
Usual careNo interventionNo intervention
Web resourcesExperimentalIndividuals 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.
Receives: Behavioral: Web resources
Personalized outreachExperimentalIndividuals 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.
Receives: Behavioral: Personalized outreach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion time covered

    Proportion time covered by recommended cancer screening

    Measured: 12 months following randomization

Secondary outcomes (1)
  1. Risk reducing surgery

    Proportion completing one or more risk reducing surgery

    Measured: 12 months following randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07053813
Sponsor's protocol ID
STUDY00021623
Other IDs
R01HG013021
Acronym
CARE-HCS
Status last verified
Jun 2025
First submitted
27 Jun 2025
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Web resources and Personalized outreach in people with Neoplastic Syndromes, Hereditary, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion time covered (time frame: 12 months following randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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