NCT05772130 · City of Hope Medical Center
Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Best Practice
Receive family letter and genomic test report
OTHER
Electronic Health Record Review
Ancillary studies
BEHAVIORAL
Personal Contact
Receive family letter and genomic test report with provider-mediated contact
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
The percentage of uptake of cascade testing among patients' first-degree at-risk relatives
Time frame: Up to 9 months after enrollment
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- PATIENTS: Willing to provide contact information for eligible first-degree relatives
- PATIENTS: \>= 2 first-degree relatives that are eligible for genetic testing and reside in the United States of America
- FIRST-DEGREE RELATIVES: Proband is a COH patient and has consented to this study
- FIRST-DEGREE RELATIVES: First-degree relative of proband
- FIRST-DEGREE RELATIVES: Resides within the United States
- FIRST-DEGREE RELATIVES: Has not undergone genetic testing for the known familial variant
- FIRST-DEGREE RELATIVES: Are fluent in English
- FIRST-DEGREE RELATIVES: Age \>= 18 years
Exclusion criteria
- 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
- FIRST-DEGREE RELATIVES: Have undergone genetic testing for the known familial variant
- FIRST-DEGREE RELATIVES: Resides outside of the United States
Where
- Duarte, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 5, 2026 · Source of record for eligibility and locations