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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05772130
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Best Practice — OTHER
    Receive family letter and genomic test report
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Personal Contact — BEHAVIORAL
    Receive family letter and genomic test report with provider-mediated contact
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Feb 14, 2023
Status verified
Dec 2025
Primary completion
Dec 21, 2026
Completion
Dec 21, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Arm I (usual care)
    Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study.
  • Experimental: Arm II (provider-mediated contact)
    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.

Primary Outcome Measure

The percentage of uptake of cascade testing among patients' first-degree at-risk relatives [ Time Frame: Up to 9 months after enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Stacy W. Gray
[email protected]
626-218-8662
Stacy W. Gray (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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