Strategy for Management of Patients With Hereditary Cancer Syndromes (HCS) in a Rural Environment

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont Medical Center
Study ID
NCT07381985
Status
Enrolling By Invitation

Conditions

  • BRCA1 Hereditary Breast and Ovarian Cancer Syndrome
  • Hereditary Cancer Syndromes
  • Lynch Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Longitudinal Cancer Genetics Follow-Up Program — BEHAVIORAL
    Participants will be enrolled in a structured, two-year longitudinal follow-up program designed for individuals with known hereditary cancer syndromes (HCS). The program includes baseline, 12-month, and 24-month clinic visits with a cancer genetics physician and, as needed, a genetic counselor. During each visit, participants will receive a personalized care plan outlining guideline-based cancer prevention and surveillance recommendations. Participants will also complete adherence surveys with their provider, and independently complete the MICRA and Care Coordination Index (CCI) surveys to assess distress and care coordination. Visits may be conducted in person or via televideo, based on clinical need and participant preference.

Study Details

This study aims to improve cancer prevention and surveillance adherence in patients with Hereditary Cancer Syndromes (HCS), particularly those living in rural areas. The study will evaluate whether enrolling HCS patients in a longitudinal clinical program with individualized care plans and regular follow-up improves adherence to guideline-recommended cancer screening and risk-reduction strategies. Secondary aims include assessing the program's impact on patient distress and perceived care coordination. The study will enroll 200 adults with known pathogenic germline mutations who were previously seen at the UVM Medical Center genetics clinic. Participants will complete surveys at baseline, 12, and 24 months to assess adherence, distress, and care coordination. Findings from this study will inform future efforts to reduce gaps in hereditary cancer care delivery, especially for rural populations.

Key Dates

Start date
Dec 29, 2023
Status verified
Jan 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Longitudinal Cancer Genetics Follow-Up Program
    Participants in this arm will be enrolled in a longitudinal cancer genetics follow-up program designed for individuals with known hereditary cancer syndromes (HCS). The intervention includes scheduled clinical visits with a cancer genetics physician and, as needed, a genetic counselor at baseline, 12 months, and 24 months. Participants will receive individualized care plans summarizing surveillance and prevention recommendations. Adherence, distress (MICRA), and care coordination (CCI) will be assessed through surveys administered at each visit.

Primary Outcome Measure

Adherence to Cancer Prevention and Surveillance Guidelines [ Time Frame: Baseline, 12 months, and 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401-

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By research site
University of Vermont Medical Center· Burlington, VT

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