Clinical trial NCT05772130: Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates, Family HOPE Study
Official title: Family HOPE Study (Hereditary Lynch Syndrome Opportunities for Participation &Amp; Engagement)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Hereditary Malignant Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

Primary outcomes:
measure: The percentage of uptake of cascade testing among patients' first-degree at-risk relatives
timeFrame: Up to 9 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Stacy W Gray
role: PRINCIPAL_INVESTIGATOR
References: