[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07381985":3,"trial-entities:NCT07381985":78,"trial-summary:NCT07381985":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":41,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":62,"locations":65,"central_contacts":74,"overall_officials":75,"references":76,"see_also_links":77},"NCT07381985","STUDY00002507\u002FUVMCC2204","Strategy for Management of Patients With Hereditary Cancer Syndromes (HCS) in a Rural Environment","ENROLLING_BY_INVITATION","2027-12-01","2026-01","2026-02-02","2023-12-29","University of Vermont Medical Center","OTHER",true,"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.","This single-arm, prospective, interventional study will assess the feasibility and impact of a structured longitudinal follow-up program for patients with Hereditary Cancer Syndromes (HCS). Eligible participants will have a known pathogenic germline variant in a cancer risk gene identified by a CLIA-approved lab at least one year prior to enrollment. All participants will be seen at baseline and followed clinically for two years, with additional visits as clinically indicated. Each participant will receive an individualized care plan developed by cancer genetics providers and supported by annual follow-up visits.\n\nThe primary objective is to assess whether participation in this program increases adherence to National Comprehensive Cancer Network (NCCN) guideline-recommended cancer screening and prevention strategies (e.g., surveillance imaging, colonoscopy, prophylactic surgery). Secondary objectives include evaluating changes in participant distress and perceived care coordination over time, and examining how rurality (defined using RUCA codes) affects outcomes.\n\nParticipants will complete three study instruments at baseline, 12-month, and 24-month follow-up visits:\n\nA gene-specific adherence survey administered by the genetics team,\n\nThe Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire to assess distress,\n\nThe Care Coordination Index (CCI) to evaluate patient-perceived coordination of care.\n\nA retrospective chart review of previously seen HCS patients will also be conducted to estimate baseline adherence rates and support feasibility assessments. Statistical analyses will use generalized probit and linear models to evaluate changes over time and assess effect modification by demographic and clinical variables such as age, sex, gene mutation, and rurality.\n\nThis study will generate critical pilot data to inform future controlled studies and improve access to high-quality cancer prevention care, particularly for underserved rural populations.",[18,19,20],"Hereditary Cancer Syndromes","BRCA1 Hereditary Breast and Ovarian Cancer Syndrome","Lynch Syndrome",[18,20,22],"Rural Health","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[26],"NA",{"count":28,"type":29},200,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Longitudinal Cancer Genetics Follow-Up Program","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.",[33],[37],{"measure":38,"description":39,"timeFrame":40},"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",[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in Participant Distress Level as Measured by the MICRA Questionnaire","This outcome will assess change in participant distress related to hereditary cancer risk using the validated Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. The MICRA provides a total distress score and subscale scores for positive experiences, intrusive thoughts, and distress. Participants complete the MICRA at baseline, 12-month, and 24-month follow-up visits. Scores will be compared over time to evaluate the impact of enrollment in a longitudinal cancer genetics program on emotional distress. Unit of Measure:\n\nMean change in MICRA total distress score.","2 years",{"measure":47,"description":48,"timeFrame":45},"Change in Perceived Care Coordination","This outcome will assess change in participants' perceived care coordination over time using the validated Care Coordination Index (CCI). The CCI is a participant-reported measure that evaluates multiple domains of care coordination. Scores range from 0 to 100, with higher scores indicating better perceived care coordination. Participants will complete the CCI at baseline, 12-month, and 24-month follow-up visits. Changes in scores will be analyzed to determine whether enrollment in a formal longitudinal follow-up program improves care integration.\n\nUnit of Measure: Mean change in Care Coordination Index (CCI) score\n\nAssessment Tool: Care Coordination Index (CCI) - participant-reported questionnaire","ALL","18 Years",null,false,{"inclusion":54,"exclusion":60,"raw_text":61},[55,56,57,58,59],"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.",[],"Inclusion Criteria:\n\n* Patients of all genders must be ≥ 18 years of age.\n* 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.\n* Patients must be able to accurately provide self-report data (i.e., per clinical judgment, cognitive function is intact).\n* Patients must be able to complete questionnaires in English.\n* Patients must have the ability to provide informed consent.\n\nExclusion Criteria:\n\n\\- Patients who tested positive for a germline pathogenic variant associated with cancer risk \\\u003C 1 year ago are not eligible.",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":12,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Burlington","Vermont","05401","United States",{"lat":72,"lon":73},44.47588,-73.21207,[],[],[],[],{"nct_id":4,"conditions":79,"biomarkers":82},[80,81,20],"BRCA1\u002F2-Associated Hereditary Breast and Ovarian Cancer Syndrome","Hereditary Neoplastic Syndrome",[83],"Germline Cancer Risk Gene",{"nct_id":4,"found":52,"summary":51,"prompt_version":51}]