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

NCT06927947 | Recruiting

• 3 other identifiers: UMCC 2024.087NCI-2025-02246HUM00257832
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Extent of utilization of the invitation portal by probands

  Up to 6 Months

• Percentage of relatives invited who subsequently enroll in the study

  Up to 6 Months

• Percentage of relative participants who have either scheduled or completed genetic testing

  Up to 3 months

Study Arms (1)

Prevention (Cascade Genetic Testing Platform)

EXPERIMENTAL

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: Communication Intervention; Other: Health Promotion and Education; Other: Informational Intervention; Other: Survey Administration

Interventions

Communication Intervention OTHER

Use relative invitation tool

Prevention (Cascade Genetic Testing Platform)

Health Promotion and Education OTHER

Receive access to the VGN

Prevention (Cascade Genetic Testing Platform)

Informational Intervention OTHER

Receive access to a Genetic Testing Family Letter

Prevention (Cascade Genetic Testing Platform)

Survey Administration OTHER

Ancillary studies

Prevention (Cascade Genetic Testing Platform)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary

Interventions

Health Promotion; Educational Status

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Elena M Stoffel

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MiGHT HelpLine

CONTACT

(734) 764-4044; MiGHT-Cascade@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 15, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)