Hereditary Cancer SyndromesLINCNCT07381985
Strategy for Management of Patients With Hereditary Cancer Syndromes (HCS) in a Rural Environment
A study testing Longitudinal Cancer Genetics Follow-Up Program in people with Hereditary Cancer Syndromes and BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, run by University of Vermont Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Cancer Syndromes, BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
- What is being tested?
- Longitudinal Cancer Genetics Follow-Up Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who tested positive for a germline pathogenic variant associated with cancer risk < 1 year ago are not eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
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.
Read the detailed description
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.
The 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.
Participants will complete three study instruments at baseline, 12-month, and 24-month follow-up visits:
A gene-specific adherence survey administered by the genetics team,
The Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire to assess distress,
The Care Coordination Index (CCI) to evaluate patient-perceived coordination of care.
A 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.
This 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.
- Conditions
- Hereditary Cancer Syndromes, BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
- Being tested
- Longitudinal Cancer Genetics Follow-Up Program
- Keywords
- Hereditary Cancer Syndromes, Lynch Syndrome, Rural Health
- Medical subject headings
- Neoplastic Syndromes, Hereditary, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Cancer Genetics Follow-Up ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Longitudinal Cancer Genetics Follow-Up Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 months, and 24 months
Secondary outcomes (2)
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:
Mean change in MICRA total distress score.
Measured: 2 years
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.
Unit of Measure: Mean change in Care Coordination Index (CCI) score
Assessment Tool: Care Coordination Index (CCI) - participant-reported questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start29 Dec 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Cancer SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Landry, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381985
- Sponsor's protocol ID
- STUDY00002507/UVMCC2204
- Acronym
- LINC
- Status last verified
- Jan 2026
- First submitted
- 8 May 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Management of Patients With Hereditary Cancer Syndromes (HCS) in a Rural Environment
- ClinicalTrials.gov ID
- NCT07381985
- Acronym / sponsor ID
- LINC / STUDY00002507/UVMCC2204
- Conditions
- Hereditary Cancer Syndromes, BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
- Keywords
- Hereditary Cancer Syndromes, Lynch Syndrome, Rural Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The 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.
Participants will complete three study instruments at baseline, 12-month, and 24-month follow-up visits:
A gene-specific adherence survey administered by the genetics team,
The Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire to assess distress,
The Care Coordination Index (CCI) to evaluate patient-perceived coordination of care.
A 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.
This 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Cancer Genetics Follow-Up Program | Experimental | Behavioral: Longitudinal Cancer Genetics Follow-Up ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who tested positive for a germline pathogenic variant associated with cancer risk < 1 year ago are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal Cancer Genetics Follow-Up ProgramParticipants 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. | Behavioural | Longitudinal Cancer Genetics Follow-Up Program |
Primary outcome
Adherence to Cancer Prevention and Surveillance Guidelines
Time frame: Baseline, 12 months, and 24 months
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.
2 secondary outcomes
Change in Participant Distress Level as Measured by the MICRA Questionnaire
Time frame: 2 years
Change in Perceived Care Coordination
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal Cancer Genetics Follow-Up Program in people with Hereditary Cancer Syndromes and BRCA1 Hereditary Breast and Ovarian Cancer Syndrome, run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Cancer Prevention and Surveillance Guidelines (time frame: Baseline, 12 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.