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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Neoplastic Syndromes, Hereditary
- 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 group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No intervention |
| Web resources | Experimental | 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. Receives: Behavioral: Web resources |
| Personalized outreach | Experimental | 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. Receives: Behavioral: Personalized outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion time covered
Proportion time covered by recommended cancer screening
Measured: 12 months following randomization
Secondary outcomes (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.
- First posted8 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic Syndromes, HereditaryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Principal investigator, Sarah Knerr, University of Washington
- Investigators
- Sarah Knerr, PhD, MPH, Principal investigator, University of Washington
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Population Management Best Practices to Preventive Genomic Medicine
- ClinicalTrials.gov ID
- NCT07053813
- Acronym / sponsor ID
- CARE-HCS / STUDY00021623
- Conditions
- Neoplastic Syndromes, Hereditary
- Keywords
- hereditary cancer syndrome, pragmatic trial, population management, care coordination
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No intervention |
| Web resources | Experimental | Behavioral: Web resourcesIndividuals 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. |
| Personalized outreach | Experimental | Behavioral: Personalized outreachIndividuals 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Previously opted out of research
- Previously opted out of genetic research
- On hospice or palliative care
- Has advanced dementia or severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web resourcesMailed educational resources through portal and USPS mail | Behavioural | Web resources |
| Personalized outreachPhone call to discuss due and overdue screening and other personalized risk management recommendations | Behavioural | Personalized outreach |
Primary outcome
Proportion time covered
Time frame: 12 months following randomization
Proportion time covered by recommended cancer screening
1 secondary outcome
Risk reducing surgery
Time frame: 12 months following randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Knerr, PhD, MPH principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
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.