An interventional study of Let's Talk Genetics Providers and Let's Talk Patients in Lynch Syndrome, sponsored by UNC Lineberger Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Health services research
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Among 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States — 20 open to participants now, 32 under way, 2 of them phase 3. Colorectal Neoplasms, Hereditary Nonpolyposis · United States.
Among the 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States, this one is the 37th largest by planned enrollment of the 42 interventional ones that give a count, is one of 3 that started in 2026, is one of 28 with no phase, reaches primary completion later than 5 of the 31 other live ones, and was the 69th registered.
146 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 60 are open to participants now.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →20 of the 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States are open now. Recruiting first, the newest first:
Vividion Therapeutics, Inc. · Sites in United States, Argentina, Belgium and 19 more countries
Ages 18+
Jessica D. St. Laurent, MD · Sites in United States
Ages 18+ · Women only · Healthy volunteers
University of Alabama at Birmingham · Sites in United States
Ages 18+ · Healthy volunteers
University of Chicago · Sites in United States
Ages 20–80
University of Colorado, Denver · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 43 Colorectal Neoplasms, Hereditary Nonpolyposis studies recruiting now, 32 (74%) set no upper age limit and 4 (9%) stop at 75 or younger; 4 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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71 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 6 · Phase 3 2
First in 1994; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 200 across 76 interventional studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Median enrollment 174 across the 42 interventional studies, 300 across the 29 observational. Of the 32 that completed or were terminated, 7 (22%) have results posted.
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1 of 71 have an industry lead sponsor. The 10 most frequent:
UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
UNC Lineberger Comprehensive Cancer Center has 2 studies filed under Colorectal Neoplasms, Hereditary Nonpolyposis — fewer than ten, so there is no comparison to draw.
8 of the studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00582296Memorial Sloan Kettering Cancer CenterMulti-Organ Screening Recommendations in Patients With Lynch Syndrome | 2026-12 |
| NCT02371135Memorial Sloan Kettering Cancer CenterMetagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes | 2027-02 |
| NCT07220239Jessica D. St. Laurent, MDMenstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome | 2027-03 |
| NCT05692596H. Lee Moffitt Cancer Center and Research InstituteThe Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics | 2027-07 |
| NCT05419011National Cancer Institute (NCI)Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome | 2027-07-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 71 studies in Colorectal Neoplasms, Hereditary Nonpolyposis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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).
Inclusion Criteria for Patients
Inclusion Criteria for Genetic Counselor
Exclusion Criteria for Patients
Exclusion Criteria for Genetic Counselor
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who are practicing genetic counselor at a medical institution.
Behavioral: Let's Talk Genetics Providers
Participants who are with diagnosis of Lynch syndrome.
Behavioral: Let's Talk Patients
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.
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.
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.
Time frame: 2 months
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.
Time frame: 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).
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 8 months
Plan to share: No
Start is estimated for Sep 2026; primary completion for Oct 2026, 1 month later.
Of 37 interventional studies with no phase under Colorectal Neoplasms, Hereditary Nonpolyposis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 86. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Colorectal Neoplasms, Hereditary Nonpolyposis →
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