What this study is
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.
What's being tested
- Longitudinal Cancer Genetics Follow-Up Program
Intervention · 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
- Sponsor
- University of Vermont Medical Center
- Conditions
- Hereditary Cancer Syndromes · BRCA1 Hereditary Breast and Ovarian Cancer Syndrome · Lynch Syndrome
- Enrolling
- 200 people
- Starts
- 2023-12-29
- Est. completion
- 2027-12-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients of all genders must be ≥ 18 years of age.
- Patients must have a known pathogenic germline variant in a cancer risk gene that was identified by a CLIA-approved lab more than one year ago.
- Patients must be able to accurately provide self-report data (i.e., per clinical judgment, cognitive function is intact).
- Patients must be able to complete questionnaires in English.
- Patients must have the ability to provide informed consent.
You can't join if
- Patients who tested positive for a germline pathogenic variant associated with cancer risk < 1 year ago are not eligible.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Vermont Medical Center
Burlington, Vermont, United States
Study team
Sponsor
University of Vermont Medical Center
Study ID STUDY00002507/UVMCC2204
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.