Clinical trial · Interventional
Strategy for Management of Patients With Hereditary Cancer Syndromes (HCS) in a Rural Environment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
| Hereditary Cancer Syndromes | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Longitudinal Cancer Genetics Follow-Up Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Longitudinal Cancer Genetics Follow-Up Program
- description
- 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.
- interventionNames
- Behavioral: Longitudinal Cancer Genetics Follow-Up Program
Primary outcomes (1)
- measure
- Adherence to Cancer Prevention and Surveillance Guidelines
- timeFrame
- Baseline, 12 months, and 24 months
- description
- Proportion of participants who are adherent to National Comprehensive Cancer Network (NCCN) guideline-recommended cancer risk-reducing strategies-including surveillance imaging, colonoscopy, chemoprevention, and prophylactic surgeries-measured at baseline, 12 months, and 24 months. Adherence will be determined through a gene-specific adherence survey completed during clinic visits and supported by clinical documentation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: \- Patients who tested positive for a germline pathogenic variant associated with cancer risk \< 1 year ago are not eligible.
References
Publications (0)
Data not yet available