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

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06927947

NCI-2025-02246 (Registry Identifier)

UMCC 2024.087

HUM00257832 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

500 participants in 1 patient group

Prevention (Cascade Genetic Testing Platform)

Experimental group

Description:

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.

Treatment:

Other: Communication Intervention

Other: Survey Administration

Other: Informational Intervention

Other: Health Promotion and Education