Hereditary Malignant Neoplasm, Hereditary Neoplastic Syndrome
Conditions
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. 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.
Interventions
OTHERCommunication Intervention
Use relative invitation tool
OTHERHealth Promotion and Education
Receive access to the VGN
OTHERInformational Intervention
Receive access to a Genetic Testing Family Letter
OTHERSurvey Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of probands that utilize the invitation tool | 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. |
| Percentage of invited relatives that engage | 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
| Measure | Time frame | Description |
|---|---|---|
| Extent of utilization of the invitation portal by probands | 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. |
| Percentage of relatives invited who subsequently enroll in the study | 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. |
| Percentage of relative participants who have either scheduled or completed genetic testing | 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. |
Countries
United States
Contacts
CONTACTMiGHT HelpLine
PRINCIPAL_INVESTIGATORElena M Stoffel
University of Michigan Rogel Cancer Center
Outcome results
None listed