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Trial Title:
Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study
NCT ID:
NCT05772130
Condition:
Hematopoietic and Lymphoid System Neoplasm
Hereditary Malignant Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive family letter and genomic test report
Arm group label:
Arm I (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm I (usual care)
Arm group label:
Arm II (provider-mediated contact)
Intervention type:
Behavioral
Intervention name:
Personal Contact
Description:
Receive family letter and genomic test report with provider-mediated contact
Arm group label:
Arm II (provider-mediated contact)
Other name:
Contact
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (usual care)
Arm group label:
Arm II (provider-mediated contact)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVES:
I. Improve rates of family member cascade testing. II. Evaluate the psychosocial impact
of provider-mediated contact to communicate genetic testing results.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Patients receive a family letter and their genomic test report to share with
at-risk first degree relatives on study.
ARM II: Patients receive a family letter and their genomic test report to share with
at-risk first degree relatives and relatives also receive provider-mediated contact to
discuss genetic results on study.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stacy W. Gray
Phone:
626-218-8662
Email:
stagray@coh.org
Investigator:
Last name:
Stacy W. Gray
Email:
Principal Investigator
Start date:
February 14, 2023
Completion date:
December 14, 2025
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772130
