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Patient Centered Clinical Decision Support for Hereditary Cancer Syndromes

Study acronym: PC-CDS
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Jul 1, 2025 to Jul 9, 2025 · Site contact updatedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2025 to Jul 9, 2025
    • Site contact updated
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06914726
Lead Sponsor HealthPartners Institute
Collaborators: National Cancer Institute (NCI)
Conditions Hereditary Breast/Ovarian Cancer (brca1, brca2), Lynch Syndrome, Genetic Variation, HBOC Syndrome, Hereditary Cancer Syndromes
Enrollment 2,488 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov