Improving genetic counseling for at-risk relatives of cancer patients
Family HOPE Study (Hereditary Lynch Syndrome Opportunities for Participation &Amp; Engagement)
NA · City of Hope Medical Center · NCT05772130
This study is testing if talking directly with a healthcare provider about genetic testing results can help at-risk family members of cancer patients get tested more often and feel better about it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT05772130 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates whether provider-mediated communication of genetic testing results can enhance genetic counseling and testing rates among at-risk relatives of cancer patients. Participants are randomized into two groups: one receives a family letter and genomic test report, while the other receives the same materials along with direct provider contact to discuss the genetic results. The study aims to improve cascade testing rates and assess the psychosocial impact of this communication method. It targets individuals with inherited cancer risk due to pathogenic gene variants.
Who should consider this trial
Good fit: Ideal candidates include cancer patients with a pathogenic germline variant who have at least two first-degree relatives eligible for genetic testing.
Not a fit: Patients without a pathogenic germline variant or those who do not have at least two at-risk first-degree relatives may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase awareness and access to genetic testing for at-risk family members, leading to earlier detection and prevention of cancer.
How similar studies have performed: Other studies have shown success with similar provider-mediated communication approaches in improving genetic counseling and testing rates.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
Study contacts
- Principal investigator: Stacy W Gray — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm, Malignant Solid Neoplasm