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

Family HOPE Study (Hereditary Lynch Syndrome Opportunities for Participation &Amp; Engagement)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hematopoietic and Lymphoid System Neoplasm
• Hereditary Malignant Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-14
• Primary completion: 2026-12-21
• Completion: 2026-12-21
• First posted: 2023-03-16
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States