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NCT Number: NCT06927947

Navigation Interventions to Improve Cascade Genetic Testing Among Relatives of Patients 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.

Recruiting

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Key information

Conditions

Hereditary Malignant Neoplasm Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Neoplastic Syndrome Neoplasms Neoplastic Syndromes, Hereditary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Elena M. Stoffel

PRINCIPAL_INVESTIGATOR

MiGHT HelpLine

CONTACT

[email protected]

734-764-4044

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication intervention

Other

Use relative invitation tool

Health Promotion and Education

Other

Receive access to the VGN

Informational intervention

Other

Receive access to a Genetic Testing Family Letter

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Percentage of probands that utilize the invitation tool

    Time frame: Up to 6 Months

    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.

  2. Percentage of invited relatives that engage

    Time frame: Up to 6 Months

    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.

Secondary outcomes

  1. Extent of utilization of the invitation portal by probands

    Time frame: Up to 6 Months

    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.

  2. Percentage of relatives invited who subsequently enroll in the study

    Time frame: Up to 6 Months

    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.

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

    Time frame: Up to 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

MiGHT HelpLine

CONTACT

[email protected]

(734) 764-4044

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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