Navigation Interventions to Improve Cascade Genetic Testing Among Relatives of Patients With Hereditary Cancer Syndromes

Not Applicable

Not yet recruiting

• Conditions: Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndrome

• Registration Number: NCT06927947
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Study Start: 2025-08-30
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• PROBANDS: Clinically confirmed autosomal dominant pathogenic germline variant (PGV) associated with a hereditary cancer syndrome
• PROBANDS: Previous evaluation by the University of Michigan (U-M) Cancer Genetics Clinic
• PROBANDS: ≥ 18 years old
• PROBANDS: Able to speak and read English
• PROBANDS: Access to the internet
• RELATIVES: Biological relative of proband
• RELATIVES: ≥ 18 years old
• RELATIVES: Able to speak and read English
• RELATIVES: Access to the internet
• RELATIVES: Have not completed germline genetic testing, per self-report at baseline

Exclusion Criteria

• RELATIVES: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider, per self-report at baseline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of probands that utilize the invitation tool	Up to 1 year	Will be defined as inviting at least 1 eligible at-risk relative. Will be assessed using descriptive statistics. Will be tabulated and summarized. Continuous variables will be summarized by mean, median, and standard deviation; histograms and boxplots will be used to further assess distributional characteristics of these variables. Categorical variables will be tabulated with frequencies and percentages. Will be estimated and presented along with a 95% confidence interval.
Percentage of invited relatives that engage	Up to 1 year	Will be defined as enrolling in the study and accessing the informational content (letter and/or virtual genetics navigator) at least 1 time. Will be assessed using descriptive statistics. Will be tabulated and summarized. Continuous variables will be summarized by mean, median, and standard deviation; histograms and boxplots will be used to further assess distributional characteristics of these variables. Categorical variables will be tabulated with frequencies and percentages. Will be estimated and presented along with a 95% confidence interval.

Secondary Outcome Measures

Name	Time	Method
Percentage of relatives invited who subsequently enroll in the study	Up to 1 year	Will be assessed using descriptive statistics. Will be tabulated and summarized. Continuous variables will be summarized by mean, median, and standard deviation; histograms and boxplots will be used to further assess distributional characteristics of these variables. Categorical variables will be tabulated with frequencies and percentages. Will be estimated and presented along with a 95% confidence interval.
Extent of utilization of the invitation portal by probands	Up to 1 year	Will be measured by the number of relatives invited out of the estimated number of eligible at-risk relatives (e.g. blood-related, have not completed genetic testing, living, 18 years or older). Will be calculated based on previously collected family records as reviewed by a genetic counselor, in conjunction with any updated information received from participants. Will be assessed using descriptive statistics. Will be tabulated and summarized. Continuous variables will be summarized by mean, median, and standard deviation; histograms and boxplots will be used to further assess distributional characteristics of these variables. Categorical variables will be tabulated with frequencies and percentages. Will be estimated and presented along with a 95% confidence interval.
Percentage of relative participants who have either scheduled or completed genetic testing	Up to 3 months	Will be assessed using descriptive statistics. Will be tabulated and summarized. Continuous variables will be summarized by mean, median, and standard deviation; histograms and boxplots will be used to further assess distributional characteristics of these variables. Categorical variables will be tabulated with frequencies and percentages. Will be estimated and presented along with a 95% confidence interval.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States