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

NCT05772130 | Recruiting DMC

• 3 other identifiers: 22261NCI-2023-01626P30CA033572
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The percentage of uptake of cascade testing among patients' first-degree at-risk relatives

  Will calculate descriptive statistics first, including the mean, median and standard deviation of the number of the first-degree and secondary-degree at-risk relatives. We will then compare the proportion of identified relatives who completed genetic testing between the intervention and the control arms with a one-sided Cochran-Mantel-Haenszel test. Type I error of 0.05 will be used and descriptive statistics will be calculated for all exploratory outcomes along with 95% confidence intervals. All statistical testing and calculation of confidence intervals will adjust for intra-proband correlation.

  Up to 9 months after enrollment

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study.

Other: Best Practice; Other: Electronic Health Record Review; Other: Survey Administration

Arm II (provider-mediated contact)

EXPERIMENTAL

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.

Other: Electronic Health Record Review; Behavioral: Personal Contact; Other: Survey Administration

Interventions

Best Practice OTHER

Receive family letter and genomic test report

Also known as: standard of care, standard therapy

Arm I (usual care)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (usual care); Arm II (provider-mediated contact)

Personal Contact BEHAVIORAL

Receive family letter and genomic test report with provider-mediated contact

Also known as: Contact

Arm II (provider-mediated contact)

Survey Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (provider-mediated contact)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Stacy W Gray

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: February 14, 2023
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)