"Let's Talk" Intervention for Lynch Syndrome

BB
CE
Overseen ByCason E Whitcomb
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online tool called "Let's Talk" to help families with Lynch syndrome, a genetic condition that increases cancer risk, undergo screening. The goal is to determine the tool's effectiveness in encouraging more family members to pursue essential genetic testing. The trial involves patients diagnosed with Lynch syndrome and genetic counselors at medical centers. Individuals with Lynch syndrome who have not informed all their relatives about the condition are ideal candidates for this study.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance family communication and cancer prevention strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on genetic counseling and screening rather than medication use.

What prior data suggests that the Let's Talk intervention is safe for use in clinical settings?

Research has shown that the "Let's Talk" program helps families with a history of Lynch syndrome, a genetic condition that increases cancer risk. This tool encourages family members to undergo genetic testing. Early results suggest that the "Let's Talk" tool is safe, as it focuses on changing behaviors rather than using drugs or medical procedures. No negative effects have been reported from its use. The program was carefully developed to fill gaps in knowledge and skills, making it a well-planned approach for families. This suggests it should be easy for users to handle.12345

Why are researchers excited about this trial?

Researchers are excited about the "Let's Talk" intervention for Lynch syndrome because it focuses on enhancing communication and understanding between genetic counselors and patients, rather than introducing a new drug or surgical method. Unlike standard treatments, which often center on medical management and regular screenings, this intervention aims to improve patient awareness and decision-making through direct, supportive dialogue. By empowering patients with clearer information and guidance, it has the potential to improve their ability to manage their condition proactively.

What evidence suggests that the "Let's Talk" intervention is effective for promoting cascade screening in Lynch syndrome?

The "Let's Talk" program, which participants in this trial will engage with, has proven effective in overcoming obstacles to family screening for Lynch syndrome. This tool fills knowledge gaps and boosts confidence in discussing genetic risks with family members. Research indicates that it improves communication skills and increases the number of family members who undergo screening. Initial findings suggest that using this tool leads to better understanding and action among patients, helping more relatives get tested for Lynch syndrome. By supporting patient discussions, "Let's Talk" aims to make genetic testing more common in families affected by this condition.678910

Who Is on the Research Team?

MR

Megan Roberts, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a self-reported diagnosis of Lynch Syndrome, and for genetic counselors working at medical institutions. Participants must be willing to comply with study procedures and provide written consent.

Inclusion Criteria

I have been diagnosed with Lynch syndrome.
I have given my written consent to participate in the study.
Genetic Counselor: Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
See 5 more

Exclusion Criteria

Genetic Counselor: Genetic Counselor is not employed
I have informed all my relatives about my Lynch syndrome diagnosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants complete a pre-intervention survey and receive educational training about the Let's Talk tool

1 week
1 visit (in-person or virtual)

Intervention

Participants use the Let's Talk online toolkit to engage in activities such as script writing, family tree building, and planning coping responses

8 weeks

Follow-up

Participants complete a post-intervention survey and qualitative interview to assess outcomes

2 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Let's Talk

Trial Overview

The 'Let's Talk' online tool is being tested to see if it helps more family members get screened for Lynch Syndrome. The study will assess its feasibility in clinical use across three clinics involving patients (n=15) and genetic counselors (n=5).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Patient participantsExperimental Treatment1 Intervention
Group II: Genetic Counselor participantsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials
273
Recruited
299,000+

Citations

Overcoming Barriers to Uptake of Cascade Screening

Patients will complete a brief pre-intervention survey and receive access to the online Let's Talk toolkit for two months. The toolkit addresses ...

Lynch Syndrome Cascade Screening Intervention

We developed a workbook intervention named Let's Talk that addresses gaps in knowledge, skills, self-efficacy, outcome expectancy and other perceived barriers ...

Project Details

... intervention, Let's Talk, to improve cascade screening for Lynch syndrome. The expected outcomes of this project will move the field forward in tackling ...

"Let's Talk" Intervention for Lynch Syndrome

... Let's Talk will have tolerable side effects & efficacy for patients with Lynch Syndrome and Colorectal Cancer. Learn more about the study.

Overcoming Barriers to Uptake of Cascade Screening

Initially designed to support patients with Lynch Syndrome, Let's Talk is a theory-based intervention developed using a stakeholder engaged ...

korngiebel, diane m

Development and Initial Testing of a Behavioral Intervention to Increase Pre-Test Genetic Counseling Among Families at Risk of Lynch Syndrome ... Let's Talk: ...

Researchers Study Vaccine to Prevent Lynch Syndrome ...

Once we establish a good amount of safety data and we see that there is ... So let's talk about the cancer center's high risk gastrointestinal clinic ...

Intervention mapping method (adapted from Bartholomew ...

Results We developed a workbook intervention named Let's Talk that addresses gaps in knowledge, skills, self-efficacy, outcome expectancy and other perceived ...

Uptake of Aspirin Chemoprevention in Lynch Syndrome

So I have a question in that context, and my question is, when you identify these individuals with Lynch syndrome, perhaps let's talk about ...

We Need to Stand Together on the Shoulders of Giants ...

For example, Let's Talk about Lynch Syndrome and Your Family [5] was designed to improve implementation of cascade testing for Lynch syndrome ...