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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Communication Intervention

    Other intervention

    Use relative invitation tool

  • Health Promotion and Education

    Other intervention

    Receive access to the VGN

  • Informational Intervention

    Other intervention

    Receive access to a Genetic Testing Family Letter

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

625 Participants
are divided into 1 treatment group
Group A: Prevention (Cascade Genetic Testing Platform)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 6 Months
2

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.

Time frame
Up to 6 Months

Secondary outcomes

1

Extent of utilization of the invitation portal by probands

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.

Time frame
Up to 6 Months
2

Percentage of relatives invited who subsequently enroll in the study

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.

Time frame
Up to 6 Months
3

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

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.

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

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