Applying Population Management Best Practices to Preventative Genomic Medicine Trial

NCT07053813 | Enrolling By Invitation

• 2 other identifiers: STUDY00021623R01HG013021
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neoplastic Syndromes, Hereditary

Keywords

hereditary cancer syndrome; pragmatic trial; population management; care coordination

Outcome Measures

Primary Outcomes (1)

• Proportion time covered

  Proportion time covered by recommended cancer screening

  12 months following randomization

Secondary Outcomes (1)

• Risk reducing surgery

  12 months following randomization

Study Arms (3)

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.

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.

Behavioral: Personalized outreach

Interventions

Web resources BEHAVIORAL

Mailed educational resources through portal and USPS mail

Web resources

Personalized outreach BEHAVIORAL

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

Personalized outreach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (2)

Denver Health

Denver, Colorado, 80204, United States

Location

Kaiser Northwest

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sarah Knerr, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Health Systems and Population Health

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IDP and supporting information will become available 6 months after the study's completion.
• Access Criteria: The University of Washington will create Data Use Agreements with organizations that wish to access the dataset and accompanying documents.

Locations

US (2)