Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive family letter and genomic test report

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Personal Contact

    Behavioral

    Receive family letter and genomic test report with provider-mediated contact

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Arm I (usual care)Active comparator 3 interventions
Group B: Arm II (provider-mediated contact)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 9 months after enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator