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

Trial Summary

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 data supports the effectiveness of the treatment Navigation Interventions for hereditary cancer syndromes?

The research highlights the importance of family communication and tailored resources in managing hereditary cancer syndromes, suggesting that interventions focusing on improving communication and addressing emotional barriers can be effective. Additionally, culturally adapted telephone genetic counseling has been shown to be effective in increasing access and quality of care for diverse populations, which may support the effectiveness of similar navigation interventions. ^{1 2 3 4 5}

Is the Communication Tools for Hereditary Cancer Syndromes treatment safe for humans?

The studies reviewed focus on the acceptability and usability of communication tools and genetic counseling protocols, which are generally safe as they involve providing information and support rather than medical interventions. Participants in these studies reported high satisfaction and found the tools easy to use, suggesting no safety concerns. ^{2 4 6 7 8}

How does the treatment 'Navigation Interventions' for hereditary cancer syndromes differ from other treatments?

Navigation Interventions for hereditary cancer syndromes focus on improving communication and decision-making through tools like web-based platforms and family conferences, which help patients and families understand genetic risks and testing options. This approach is unique because it emphasizes education and empowerment rather than traditional medical treatments, aiming to enhance patient knowledge and support informed decision-making. ^{2 6 9 10 11}

What is the purpose of this trial?

This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. Once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. The uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. The Cascade Genetic Testing Platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. Using the Cascade Genetic Testing Platform may improve ways to share information about hereditary risk with biological relatives.

Research Team

Elena M Stoffel

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Experiences of Family Communication and Cascade Genetic Testing for Hereditary Cancer in Medically Underserved Populations-A Qualitative Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Experience Gained from the Development and Execution of a Multidisciplinary Multi-syndrome Hereditary Colon Cancer Family Conference. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Applying the framework for developing and evaluating complex interventions to increase family communication about hereditary cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cultural adaptations to a telephone genetic counseling protocol and booklet for Latina breast cancer survivors at risk for hereditary breast and ovarian cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Informational needs of individuals from families harboring BRCA pathogenic variants: A systematic review and content analysis. [2023]

6. Switzerland 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluating co-created patient-facing materials to increase understanding of genetic test results. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Cancer communication research in the era of genomics and precision medicine: a scoping review. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Piloting a Spanish-Language Web-Based Tool for Hereditary Cancer Genetic Testing. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A cancer genetics toolkit improves access to genetic services through documentation and use of the family history by primary-care clinicians. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Exploring attitudes, beliefs, and communication preferences of Latino community members regarding BRCA1/2 mutation testing and preventive strategies. [2022]