Behavioral Intervention for Lynch Syndrome

Overseen By Haoyang Yan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cancer, Cognitive dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist individuals with Lynch syndrome, a genetic condition that increases the risk of certain cancers. The goal is to determine if the new method, which includes a booklet with important information, is more effective than providing basic information alone. Participants will be divided into two groups: one will receive the new booklet, while the other will receive typical care with additional resources. English-speaking adults who are blood relatives of someone tested for Lynch syndrome and have not started any related genetic services may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for individuals with Lynch syndrome.

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 behavioral intervention, so it's likely you won't need to change your medication, but you should confirm with the trial organizers.

What prior data suggests that this behavioral intervention is safe?

Research has shown that programs designed to assist individuals with genetic conditions, such as the one being tested for Lynch syndrome, are generally safe. Lynch syndrome is a common genetic condition that increases the risk of colon cancer. These programs typically focus on providing information and support, avoiding medical procedures and usually not causing physical harm.

There is little evidence of negative effects directly linked to these programs. However, some studies have found that individuals with Lynch syndrome might experience stress or anxiety related to genetic testing and counseling. Awareness of these possible emotional effects is important, although they do not affect everyone. Overall, the approach used in this trial is considered well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Lynch Syndrome because it aims to enhance genetic counseling and testing processes. Unlike standard care, which often provides just basic information and resources, this intervention includes a specially designed booklet that may improve understanding and engagement with genetic services. By potentially increasing awareness and proactive management of Lynch Syndrome, this approach could lead to earlier interventions and better health outcomes for patients at risk.

What evidence suggests that this behavioral intervention could be effective for Lynch syndrome?

Studies have shown that genetic counseling benefits individuals with inherited colorectal cancer, such as Lynch syndrome. This counseling improves emotional well-being and cognitive and behavioral responses, with a moderate effect on behavior. Research also indicates that many individuals with Lynch syndrome remain unaware of their condition, highlighting the importance of these services. In this trial, participants in the intervention arm will receive a clinical letter accompanied by an intervention booklet to enhance understanding and action. The enhanced usual care arm provides a clinical letter with basic information and resources. Addressing mental health challenges, like depression, can significantly increase the number of individuals getting tested for Lynch syndrome. These findings suggest that such support can help more people understand their risk and take action. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for untested relatives of patients with Lynch Syndrome, a genetic condition that increases the risk of colorectal cancer and other cancers. Participants will be asked to complete surveys and may opt into an exit interview.

Inclusion Criteria

Probands must be English speaking

I am mentally capable of understanding and participating in the study.

Participants must be English-speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a baseline survey collecting demographics and medical history

1 week

1 visit (virtual)

Intervention

Participants receive either the behavioral intervention or enhanced usual care information

1 month

1 visit (virtual)

Follow-up

Participants complete follow-up surveys to assess behavioral and psychosocial outcomes

6 months

2 visits (virtual)

Exit Interview

Participants who complete the study are invited to provide feedback in an exit interview

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Services Behavioral Intervention

Trial Overview The study is testing whether receiving a special booklet or a control clinical letter helps families at risk of Lynch Syndrome make decisions about genetic services. It's a pilot trial where people are randomly chosen to get one option or the other.

How Is the Trial Designed?

Group I: intervention Experimental Treatment 1 Intervention

This arm provides a clinical letter with an intervention booklet

Group II: enhanced usual care Active Control 1 Intervention

This arm provides a clinical letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. nature.com nature.com/articles/s41431-025-01921-x

The efficacy of genetic counselling for familial colorectal ... The findings of the present trial robustly support the efficacy of genetic counselling for inherited and familial CRC. The primary outcome, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12131688/

The efficacy of genetic counseling for familial colorectal ... Results indicate that genetic counseling is effective for affective (d = 0.162), cognitive (d = 0.298), and behavioral outcomes (d = 0.539).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447350/

Hereditary Nonpolyposis Colon Cancer (Lynch Syndrome) Lynch syndrome accounts for only 3%–5% of colorectal cancer cases; however, most patients with Lynch syndrome are not diagnosed, leading to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021019869

Exploring the psychological impact of providing genetic ... Lerman et al. reported that the presence of depressive symptoms significantly reduced rates of genetic testing for Lynch syndrome (LS), a dominantly inherited ...

5. gimjournal.org gimjournal.org/article/S1098-3600(21)02091-8/fulltext

The cost-effectiveness of genetic testing strategies for ... In this article, we present an economic evaluation of genetic testing protocols to identify Lynch syndrome among newly diagnosed cases of CRC in order to ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK564511/

Hereditary Nonpolyposis Colon Cancer (Lynch Syndrome) Hereditary nonpolyposis colorectal cancer (HNPCC), also known as Lynch syndrome, is the most common genetic syndrome associated with colon cancer.

7. nature.com nature.com/articles/gim200749

The impact of predictive genetic testing for hereditary ... Lynch HT, de la Chapelle A . Genetic susceptibility to non-polyposis colorectal cancer. J Med Genet 1999; 36: 801–818. CAS PubMed PubMed Central Google Scholar.

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/215212

Genetic Counseling and Testing in Families With ... HEREDITARY nonpolyposis colorectal cancer (also known as HNPCC and Lynch syndrome) is the most common hereditary form of colon cancer. It is estimated to ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01850654

Ohio Colorectal Cancer Prevention Initiative (OCCPI) Participants will have free tumor screening for Lynch syndrome, and may be eligible for free genetic testing and free genetic counseling as part of this study.