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Patient Centered Clinical Decision Support for Hereditary Cancer Syndromes

NCT06914726 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2488

Last updated 2025-08-05

No results posted yet for this study

Summary

The goal of this clinical trial is to address care gaps for participants at high risk of breast and ovarian cancer (HBOC), or Lynch syndrome (LS) because of testing positive for specific genetic variants. A patient-centered clinical decision support (PC-CDS) tool will help identify participants with genetic variations and display recommendations for referrals and testing to the clinician and participant at a primary care visit. The main question the study aims to answer is:

\- Does clinical decision support for participants with hereditary cancer syndromes improve the use of evidence-based cancer prevention care.

Participants being seen in the PC-CDS group are compared to participants being seen in usual care (UC) to see if they are up to date on guideline-based cancer prevention care and to see if participants in the PC-CDS group report more shared decision making and higher rates of self-management of their genetic cancer risks.

Participants will be asked to answer survey questions.

Conditions

  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Lynch Syndrome
  • Genetic Variation
  • HBOC Syndrome
  • Hereditary Cancer Syndromes

Interventions

OTHER

Patient Centered Clinical Decision Support (PC-CDS)

The intervention provides patient specific recommendations on managing cancer risk due to hereditary cancer gene variants that is integrated into an existing point of care clinical decision support system that algorithmically identifies study-eligible patients and deploys patient-specific CDS output at an index visit and all subsequent primary care encounters using the most up to date available clinical information.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Patrick J. O'Connor, MD, MPH, MA · HealthPartners Institute

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2028-06-30
Completion
2029-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914726 on ClinicalTrials.gov