About this trial
This clinical trial tests whether provider-mediated communication of genetic testing results to at-risk relatives of cancer patients can help improve genetic counseling and testing rates. Approximately 15% of people with cancer have an inherited form of cancer due to changes in a gene that they have inherited from one of their parents. These changes increase a person's risk for developing cancer. Most people who have an inherited harmful change in a cancer risk gene don't know that they have it and are therefore not able to get the health care that they need. The primary reason for this problem has been a lack of genetic counseling and testing for cancer patients and patients with a strong family history of cancer. Another reason for this lack of awareness is that, when cancer runs in a family, the patient who carries the gene change usually has to communicate the genetic risk information to their family members. When this process doesn't work well, family members may not know that they need to get genetic testing and then may not get potentially life-saving care. Provider-mediated contact to discuss genetic test results may help improve rates of genetic testing among at-risk relatives of patients with a family cancer syndrome.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
PATIENTS: Enrolled in City of Hope (COH) institutional review board (IRB) 07047 or have been seen by COH Genetics for genetic testing
PATIENTS: Have an pathogenic/ likely pathogenic germline variant
PATIENTS: Fluent in English
PATIENTS: Age >= 18 years
Disqualifiers
PATIENTS: Unable to provide informed consent
PATIENTS: =< 2 at-risk first-degree relatives who are eligible for genetic testing and/or reside within the United States
PATIENTS: Unwilling to provide contact information for family members
FIRST-DEGREE RELATIVES: Unable or unwilling to provide informed consent
Trial design
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive family letter and genomic test report
Electronic Health Record Review
Other interventionAncillary studies
Personal Contact
BehavioralReceive family letter and genomic test report with provider-mediated contact
Survey Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
The percentage of uptake of cascade testing among patients' first-degree at-risk relatives
Will calculate descriptive statistics first, including the mean, median and standard deviation of the number of the first-degree and secondary-degree at-risk relatives. We will then compare the proportion of identified relatives who completed genetic testing between the intervention and the control arms with a one-sided Cochran-Mantel-Haenszel test. Type I error of 0.05 will be used and descriptive statistics will be calculated for all exploratory outcomes along with 95% confidence intervals. All statistical testing and calculation of confidence intervals will adjust for intra-proband correlation.
Sponsors and contacts
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator