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

NCT ID: NCT06927947

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2026-09-30

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

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.

Conditions

Hereditary Malignant Neoplasm; Hereditary Neoplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Communication Intervention

Intervention Type: OTHER

Use relative invitation tool

Health Promotion and Education

Intervention Type: OTHER

Receive access to the VGN

Informational Intervention

Intervention Type: OTHER

Receive access to a Genetic Testing Family Letter

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Communication Intervention

Use relative invitation tool

Intervention Type: OTHER

Health Promotion and Education

Receive access to the VGN

Intervention Type: OTHER

Informational Intervention

Receive access to a Genetic Testing Family Letter

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena M Stoffel

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

MiGHT HelpLine

Role: CONTACT

MiGHT-Cascade@med.umich.edu

(734) 764-4044

Facility Contacts

MiGHT HelpLine

Role: primary

MiGHT-Cascade@med.umich.edu

734-764-4044

Other Identifiers

NCI-2025-02246

Identifier Type: REGISTRY

Identifier Source: secondary_id

HUM00257832

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2024.087

Identifier Type: -

Identifier Source: org_study_id