Communication Tools for Hereditary Cancer Syndromes

Overseen By MiGHT HelpLine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Prior genetic testing, Scheduled genetics appointment

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests user-friendly online tools to help families discuss their hereditary cancer risk and simplify access to genetic testing. Hereditary cancer syndromes, which can be inherited, account for 5% to 10% of all cancers, and early identification of these risks can be life-saving. The trial centers on a virtual tool called the Cascade Genetic Testing Platform, which educates relatives of patients with known genetic changes about their risks and testing options. This platform includes navigation interventions, strategies designed to guide and support individuals through the genetic testing process. Ideal candidates for this trial have a family member with a confirmed genetic change linked to cancer and have not yet undergone genetic testing themselves. As an unphased trial, this study offers a unique opportunity to access innovative tools that could significantly impact family health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on communication tools rather than medication use.

What prior data suggests that these web-based tools are safe for improving communication about hereditary cancer risk?

Research has shown that online tools for discussing hereditary cancer risk are generally safe. Tools like the Cascade Genetic Testing Platform assist families in discussing genetic testing. They do not involve medical treatments or drugs, eliminating concerns about side effects.

These tools aim to simplify the sharing of information about genetic risks within families. They provide educational content and straightforward access to genetic testing. Being online, these tools are user-friendly and pose no physical risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Communication Tools for Hereditary Cancer Syndromes because it introduces a novel way to engage family members at risk of hereditary cancer. Unlike traditional methods that rely on direct medical consultations, this trial uses a virtual Cascade Genetic Testing Platform. This platform includes interactive tools like the Genetic Testing Family Letter and the VGN, which personalize information and support for relatives. These tools aim to overcome barriers to genetic testing by enhancing readiness and understanding, making it easier for families to access essential genetic evaluations and support.

What evidence suggests that the Cascade Genetic Testing Platform is effective for improving communication about hereditary cancer risk?

Research has shown that online tools can assist families in discussing their hereditary cancer risk. In this trial, participants will use the Cascade Genetic Testing Platform, an online tool designed to facilitate genetic testing for relatives. Studies have found that when individuals learn about their increased cancer risk due to genetic factors, they can take proactive steps to manage their health. Cascade genetic testing identifies these risks, and online guidance tools are recommended to encourage more family members to undergo testing. By simplifying genetic information and actions, these tools aim to increase the number of relatives tested, aiding in early cancer detection and prevention. ^{1 2 4 6 7}

Who Is on the Research Team?

Elena M Stoffel

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for relatives of patients with hereditary cancer syndromes who are interested in learning about their own genetic risk. It aims to help them communicate and understand the importance of genetic testing. Participants should be willing to use web-based tools for education and communication.

Inclusion Criteria

I have a genetic variant linked to hereditary cancer.

My relatives are 18 years old or older.

I have not had genetic testing for inherited conditions.

Exclusion Criteria

I or my relatives have had genetic testing for cancer or have an appointment for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Cascade Genetic Testing Platform to improve communication about hereditary cancer risk and facilitate genetic testing

Up to 1 year

Virtual interactions through the platform

Follow-up

Participants are monitored for engagement with the platform and uptake of genetic testing

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Navigation Interventions

Trial Overview The study tests web-based interventions like the Cascade Genetic Testing Platform, which provides information and support to improve family communication about cancer risks and encourage genetic testing among relatives of cancer patients.

How Is the Trial Designed?

Group I: Prevention (Cascade Genetic Testing Platform) Experimental Treatment 4 Interventions

PROBANDS: Probands use the relative invitation tool to invite at-risk relatives to participate. RELATIVES: Participants receive access to the virtual Cascade Genetic Testing Platform, which includes a Genetic Testing Family Letter and access to the VGN. The Genetic Testing Family Letter provides information about the genetic diagnosis in the family, instructions for the relatives on how to schedule a genetic evaluation, and contact information for the U-M Cancer Genetics Clinic. The VGN is an interactive web-based tool that provides personalized information addressing readiness, barriers and motivators to testing, and knowledge, and presents educational content about genetic testing and information about testing options, including how to access them on study.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

Co-creating patient-facing materials for genetic test results, specifically for congenital hypogonadotropic hypogonadism, resulted in high-quality resources that were rated as understandable and actionable by patients and parents, with an average reading level suitable for 8th-9th graders.

The study found that while most aspects of the materials scored highly in understandability (90%-97%), visual aids received the lowest rating (89%), indicating a need for improvement in this area to enhance overall comprehension, especially for patients with varying levels of health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating co-created patient-facing materials to increase understanding of genetic test results. Dwyer, AA., Au, MG., Smith, N., et al.[2022]

A study involving 25 patients with hereditary cancer revealed that while most patients (80%) shared their genetic testing results with relatives, many relatives did not pursue cascade genetic testing (CGT) due to low perceived susceptibility to hereditary cancer.

Relatives expressed distress upon learning about the patient's genetic test results and were fearful of their own potential results, highlighting the need for tailored resources to support families in understanding hereditary cancer risks and improving communication about CGT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Family Communication and Cascade Genetic Testing for Hereditary Cancer in Medically Underserved Populations-A Qualitative Study. Bednar, EM., Rauh-Hain, JA., Garcia, JJ., et al.[2023]

The Family Gene Toolkit, a customized web application for families with BRCA1/BRCA2 pathogenic variants, was developed based on feedback from 68 women and is designed to improve family communication about genetic testing results.

In a usability test with 18 women, participants reported high satisfaction with the toolkit, finding it useful for coping strategies and family communication, indicating its potential to promote cascade genetic testing among at-risk relatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of the Family Gene Toolkit for Swiss and Korean Families Harboring BRCA1/BRAC2 Pathogenic Variants: A Web-Based Platform for Cascade Genetic Testing. Baroutsou, V., Duong, V., Signorini, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06927947

Study Details | NCT06927947 | Navigation Interventions to ... This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to ...

2. trialx.com trialx.com/clinical-trials/listings/321734/navigation-interventions-to-improve-cascade-genetic-testing-among-relatives-of-patients-with-hereditary-cancer-syndromes/

Hereditary Neoplastic Syndrome ) ( NCT06927947 ) This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11751770/

Cascade genetic testing: an underutilized pathway to ... The identification of inherited cancer syndromes offers the opportunity for delivery of tailored cancer treatment to patients and prevention ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06927947?term=AREA%5BBasicSearch%5D(hereditary%20cancer)&rank=8

Navigation Interventions to Improve Cascade Genetic ... This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to ...

5. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.22.00303

Cascade Testing for Hereditary Cancer Syndromes Evidence-based guidelines recommend cascade genetic counseling and testing for hereditary cancer syndromes, providing relatives the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10991315/

Strategies to improve implementation of cascade testing in ... Hereditary cancer syndromes constitute approximately 10% of all cancers. Cascade testing involves testing of at-risk relatives to determine if ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP.2024.20.10_suppl.279

Implementation of hereditary cancer risk assessment in ... Results: Between February 2023 and March 2024, 4,540 primary care patients were offered hereditary cancer risk assessment and 3,497 (77%) ...