Clinical trial NCT06927947: Navigation Interventions to Improve Cascade Genetic Testing Among Relatives of Patients With Hereditary Cancer Syndromes
Official title: Testing Effectiveness of Navigation Interventions to Increase Uptake of Cascade Genetic Testing Among Relatives of Individuals Diagnosed With Hereditary Cancer Syndromes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hereditary Malignant Neoplasm
Hereditary Neoplastic Syndrome
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of probands that utilize the invitation tool
timeFrame: Up to 6 Months
measure: Percentage of invited relatives that engage
timeFrame: Up to 6 Months
Secondary outcomes:
measure: Extent of utilization of the invitation portal by probands
timeFrame: Up to 6 Months
measure: Percentage of relatives invited who subsequently enroll in the study
timeFrame: Up to 6 Months
measure: Percentage of relative participants who have either scheduled or completed genetic testing
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Elena M Stoffel
role: PRINCIPAL_INVESTIGATOR
References: