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

NCT07381985 | Enrolling By Invitation DMC

• 1 other identifier: STUDY00002507/UVMCC2204
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

Hereditary Cancer Syndromes; Lynch Syndrome; Rural Health

Outcome Measures

Primary Outcomes (1)

• Adherence to Cancer Prevention and Surveillance Guidelines

  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.

  Baseline, 12 months, and 24 months

Secondary Outcomes (2)

• Change in Participant Distress Level as Measured by the MICRA Questionnaire

  2 years

• Change in Perceived Care Coordination

  2 years

Study Arms (1)

Longitudinal Cancer Genetics Follow-Up Program

EXPERIMENTAL

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.

Behavioral: Longitudinal Cancer Genetics Follow-Up Program

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.

Longitudinal Cancer Genetics Follow-Up Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• \- Patients who tested positive for a germline pathogenic variant associated with cancer risk \< 1 year ago are not eligible.

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oncology & Hematology

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: February 2, 2026
• Study Start: December 29, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)