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

Testing Effectiveness of Navigation Interventions to Increase Uptake of Cascade Genetic Testing Among Relatives of Individuals Diagnosed With Hereditary Cancer Syndromes

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.

Study Overview

• Status: Recruiting
• Conditions: Hereditary Neoplastic Syndrome; Hereditary Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Communication Intervention; Other: Health Promotion and Education; Other: Informational Intervention

Detailed Description

03JUN2025- Amendment was approved that shorten the study timeline from 12 to 6 months. We believe this is sufficient to capture our primary outcome (participation) and a shorter timeline may keep participants more engaged.

22MAY2026- Amendment was approved adjusting enrollment goals to account for new accrual of prospective probands and their relatives, and to clarify realistic expectations for relative enrollment numbers.

• Study Type: Interventional
• Enrollment (Estimated): 625
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MiGHT HelpLine; Phone Number: (734) 764-4044; Email: MiGHT-Cascade@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Comprehensive Cancer Center
      • Principal Investigator: Elena M. Stoffel
      • Contact: MiGHT HelpLine; Phone Number: 734-764-4044; Email: MiGHT-Cascade@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prevention (Cascade Genetic Testing Platform); 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.

Other: Survey Administration; Ancillary studies; Other: Communication Intervention; Use relative invitation tool; Other: Health Promotion and Education; Receive access to the VGN; Other: Informational Intervention; Receive access to a Genetic Testing Family Letter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of probands that utilize the invitation tool	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.	Up to 6 Months
Percentage of invited relatives that engage	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.	Up to 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of relative participants who have either scheduled or completed genetic testing	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.	Up to 3 months
Extent of utilization of the invitation portal by probands	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.	Up to 6 Months
Percentage of relatives invited who subsequently enroll in the study	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.	Up to 6 Months

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Elena M Stoffel, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplastic Syndromes, Hereditary; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Health Education; Educational Status; Health Promotion
• Other Study ID Numbers: UMCC 2024.087; NCI-2025-02246 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00257832 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No