Lynch SyndromeNCT07304063
Overcoming Barriers to Uptake of Cascade Screening
A study testing Let's Talk Genetics Providers and Let's Talk Patients in people with Lynch Syndrome, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Lynch syndrome is a genetic condition that increases cancer risk. The public health impact of genetic testing for disease prevention hinges on cascade screening, which is the systematic identification and testing of blood relatives after a family member has been diagnosed with a genetic condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- Let's Talk Genetics Providers and Let's Talk Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2026
- 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
- 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 Lynch syndrome diagnosis.
- Written informed consent obtained to participate in the study.
Show all 10Show fewer
- 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.
Who cannot join
- The patient has already notified all relatives about their diagnosis with Lynch syndrome.
- Genetic Counselor is not employed.
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 North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Let's Talk: Overcoming Barriers to Uptake of Cascade Screening Through a Stakeholder-informed Online Intervention
Lynch syndrome is a genetic condition that increases cancer risk. The public health impact of genetic testing for disease prevention hinges on cascade screening, which is the systematic identification and testing of blood relatives after a family member has been diagnosed with a genetic condition. Despite its importance in disease prevention, only half of first-degree relatives of individuals with Lynch syndrome undergo cascade screening. To address this gap, the study will pilot test an online version of Let's Talk, a novel intervention designed to support and promote cascade screening. This intervention tool is designed to support and encourage more family members to get screened. The purpose of this study aim is to assess the feasibility of the online Let's Talk tool in clinical use by examining implementation and effectiveness outcomes related to the use of the planning tool across three clinics at a large academic-affiliated medical center with patients (n=15) seen by one of five genetic counselors (n=5).
Read the detailed description
The overall objective of this research study is to design an interactive online format for Let's Talk content, and pilot test Let's Talk to gain feasibility data for its clinical use among patients diagnosed with Lynch syndrome. The rationale for this study is that it has the potential to improve cascade screening uptake and could be adapted to other hereditary conditions in future work. The expected outcomes of this project will move the field forward in addressing barriers to cascade screening and will inform cascade screening for Lynch syndrome as well as for other conditions, such as hereditary breast and ovarian cancer syndrome and familial hypercholesterolemia.
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
- Lynch Syndrome
- Being tested
- Let's Talk Genetics Providers, Let's Talk Patients
- Keywords
- Screening, cascade screening
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Talk Genetics ProvidersBehavioural
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 PatientsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Genetic Counselor participants | Experimental | Participants who are practicing genetic counselor at a medical institution. Receives: Behavioral: Let's Talk Genetics Providers |
| Patient participants | Experimental | Participants who are with diagnosis of Lynch syndrome. Receives: Behavioral: Let's Talk Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient knowledge
Change in patient knowledge will be measured by an online survey prior to and after the intervention. Knowledge will be measured using a 12-item knowledge scale developed by Bannon et al. (2014) covering topics such as hereditary basis of Lynch syndrome (LS), transmission pattern, risks of LS-related cancers, surveillance strategies, and prophylactic options. All items on the survey are of multiple-choice format and will be scored from 0-100% based on the proportion of correct answers. Change in patient knowledge across timepoints will be analyzed using a Wilcoxon signed rank test.
Measured: 2 months
Secondary outcomes (5)
Let's Talk reach
Reach will be calculated as the proportion of individuals who provide informed consent among those approached for participation. This proportion will be calculated based on reports from the five participating genetic counselors.
Measured: 8 months
Let's Talk provider adoption
Adoption will be defined as the proportion of the five participating genetic providers who shared the intervention with at least one patient during the study period. This will be calculated by dividing the number of providers who report sharing the intervention with >1 patient by the total number of participating providers (n=5).
Measured: 8 months
Let's Talk patient acceptability
Patient acceptability will be defined as patient satisfaction with the intervention. This will be evaluated using a four-item scale included in the post-intervention patient survey. Patients will indicate their level of agreement with four acceptability-related statements on a five-point Likert scale, adapted from Weiner et al. (2017), ranging from "Completely disagree" to "Completely agree".
Measured: 8 months
Let's Talk provider feasibility
Provider feasibility will examine the extent to which providers feel they can successfully share this tool with relevant patients in a clinical setting. This will be evaluated using a four-item scale included in the end-of-study provider survey. Providers will indicate their level of agreement with four feasibility-related statements on a five-point Likert scale, adapted from Weiner et al. (2017), ranging from "Completely disagree" to "Completely agree".
Measured: 8 months
Let's Talk maintenance
Maintenance will be defined as a provider's intention to continue sharing the Let's Talk intervention with patients after the study period ends. This will be assessed through qualitative interviews conducted at the end of each provider's participation. Providers will be asked whether they intend to continue using the tool in their practice to explain their reasoning. The proportion of providers who indicate an intention to continue using the tool will be reported.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Megan Roberts, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304063
- Sponsor's protocol ID
- LCCC2516-AIM2
- Other IDs
- R21HG013417
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Let's Talk: Overcoming Barriers to Uptake of Cascade Screening Through a Stakeholder-informed Online Intervention
- ClinicalTrials.gov ID
- NCT07304063
- Acronym / sponsor ID
- LCCC2516-AIM2
- Conditions
- Lynch Syndrome
- Keywords
- Screening, cascade screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Dec 2025 (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.
Lynch syndrome is a genetic condition that increases cancer risk. The public health impact of genetic testing for disease prevention hinges on cascade screening, which is the systematic identification and testing of blood relatives after a family member has been diagnosed with a genetic condition. Despite its importance in disease prevention, only half of first-degree relatives of individuals with Lynch syndrome undergo cascade screening. To address this gap, the study will pilot test an online version of Let's Talk, a novel intervention designed to support and promote cascade screening. This intervention tool is designed to support and encourage more family members to get screened. The purpose of this study aim is to assess the feasibility of the online Let's Talk tool in clinical use by examining implementation and effectiveness outcomes related to the use of the planning tool across three clinics at a large academic-affiliated medical center with patients (n=15) seen by one of five genetic counselors (n=5).
Detailed description
The overall objective of this research study is to design an interactive online format for Let's Talk content, and pilot test Let's Talk to gain feasibility data for its clinical use among patients diagnosed with Lynch syndrome. The rationale for this study is that it has the potential to improve cascade screening uptake and could be adapted to other hereditary conditions in future work. The expected outcomes of this project will move the field forward in addressing barriers to cascade screening and will inform cascade screening for Lynch syndrome as well as for other conditions, such as hereditary breast and ovarian cancer syndrome and familial hypercholesterolemia.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic Counselor participants | Experimental | Behavioral: Let's Talk Genetics ProvidersParticipants who are practicing genetic counselor at a medical institution. |
| Patient participants | Experimental | Behavioral: Let's Talk PatientsParticipants who are with diagnosis of Lynch syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 Lynch syndrome diagnosis.
Key exclusion criteria (2 listed)
- The patient has already notified all relatives about their diagnosis with Lynch syndrome.
- Genetic Counselor is not employed.
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 |
|---|---|---|
| Let's Talk Genetics ProvidersProviders 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. | Behavioural | Genetic Counselor participants |
| Let's Talk PatientsPatients 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. | Behavioural | Patient participants |
Primary outcome
Change in patient knowledge
Time frame: 2 months
Change in patient knowledge will be measured by an online survey prior to and after the intervention. Knowledge will be measured using a 12-item knowledge scale developed by Bannon et al. (2014) covering topics such as hereditary basis of Lynch syndrome (LS), transmission pattern, risks of LS-related cancers, surveillance strategies, and prophylactic options. All items on the survey are of multiple-choice format and will be scored from 0-100% based on the proportion of correct answers. Change in patient knowledge across timepoints will be analyzed using a Wilcoxon signed rank test.
5 secondary outcomes
Let's Talk reach
Time frame: 8 months
Let's Talk provider adoption
Time frame: 8 months
Let's Talk patient acceptability
Time frame: 8 months
Let's Talk provider feasibility
Time frame: 8 months
Let's Talk maintenance
Time frame: 8 months
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 26 Aug 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lynch Syndrome
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The Cancer of the Pancreas Screening-5 CAPS5)Study
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Not yet recruitingObservational study
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
Lynch Syndrome
RecruitingPhase 2
A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum
Colorectal Adenocarcinoma
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
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.
Megan Roberts, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Talk Genetics Providers and Let's Talk Patients in people with Lynch Syndrome, run by UNC Lineberger Comprehensive Cancer 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 10 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Aug 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?
Contact Becca Bosch (919-984-0000, Rebecca_Bosch@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient knowledge (time frame: 2 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 26 Aug 2026.