Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-31
2026-10-31
Brief Summary
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Detailed Description
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Initially designed to support patients with Lynch Syndrome, Let's Talk is a theory-based intervention developed using a stakeholder engaged methodology that is responsive to reported barriers to cascade screening. Let's Talk was created in collaboration with patients and providers. It was designed to be introduced by the patient's provider within the existing clinic workflow, and the remainder of the intervention could be completed at home by the patient with their family.
In this aim (Aim 2), the Let's Talk cascade screening digital intervention will be pilot tested to assess feasibility for clinical use. It will be tested by genetic counselors (n=5) and their patients (n=15) who have been diagnosed with LS and are currently sharing information about their diagnosis with relatives. Genetics providers will be identified from one of three genetics clinics. After consenting to participate, they will be asked to complete a short pre-intervention survey and take part in a brief educational training to learn about the Let's Talk tool. Then, providers will help recruit eligible patients seen in one of the genetics clinics who have a need for cascade screening for Lynch Syndrome.
Once each patient enrolls, they will complete a short pre-intervention survey and then will be introduced to the online Let's Talk toolkit. They will have access to the toolkit for the following two months. The online tool was adapted from a previously developed workbook intervention guided by key stakeholders in Lynch syndrome care and patients. The toolkit addresses gaps in knowledge, self-efficacy, outcome expectancy, and other perceived barriers to cascade screening for Lynch syndrome. The adapted online tool will guide patients through the cascade screening process using evidence-based practices such as goal setting, guided practice, gain-framing, and information chunking. Patient participants will be asked to utilize the online tool to complete a variety of activities such as script writing, family tree building, and planning coping responses in the two months following enrollment.
Two months following the delivery of Let's Talk, patients will be given a brief online survey and a qualitative interview to assess outcomes (n=15). Post-intervention surveys and interviews will also be conducted with genetic counselors at the end of the study (n=5).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Genetic Counselor participants
Participants who are practicing genetic counselor at a medical institution.
Let's Talk Genetics Providers
Providers will complete a brief pre-intervention survey and a short training on the Let's Talk tool. They will then help recruit eligible patients from genetics clinics who need cascade screening for Lynch syndrome. After the intervention, providers will complete post-intervention surveys and interviews.
Patient participants
Participants who are with diagnosis of Lynch syndrome.
Let's Talk Patients
Patients will complete a brief pre-intervention survey and receive access to the online Let's Talk toolkit for two months. The toolkit addresses key barriers to cascade screening for Lynch syndrome by building knowledge, confidence, and communication skills through simple, evidence-based activities. After two months, patients will complete a post-intervention survey and participate in a qualitative interview.
Interventions
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Let's Talk Genetics Providers
Providers will complete a brief pre-intervention survey and a short training on the Let's Talk tool. They will then help recruit eligible patients from genetics clinics who need cascade screening for Lynch syndrome. After the intervention, providers will complete post-intervention surveys and interviews.
Let's Talk Patients
Patients will complete a brief pre-intervention survey and receive access to the online Let's Talk toolkit for two months. The toolkit addresses key barriers to cascade screening for Lynch syndrome by building knowledge, confidence, and communication skills through simple, evidence-based activities. After two months, patients will complete a post-intervention survey and participate in a qualitative interview.
Eligibility Criteria
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Inclusion Criteria
* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
* Age ≥ 18 years at the time of consent.
* Written informed consent obtained to participate in the study.
* Self-reported Lynch syndrome diagnosis.
* Written informed consent obtained to participate in the study.
* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
* Age ≥ 18 years at the time of consent.
* Written informed consent obtained to participate in the study.
* Self-reported employment as a practicing genetic counselor at a medical institution.
Exclusion Criteria
* Genetic Counselor is not employed.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Human Genome Research Institute (NHGRI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Megan Roberts, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2516-AIM2
Identifier Type: -
Identifier Source: org_study_id