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)

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Hereditary Malignant Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Best Practice; Behavioral: Personal Contact

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Stacy W. Gray; Phone Number: 626-218-8662; Email: stagray@coh.org
      • Principal Investigator: Stacy W. Gray

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Best Practice; Receive family letter and genomic test report; Other Names: standard of care; standard therapy
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.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Behavioral: Personal Contact; Receive family letter and genomic test report with provider-mediated contact; Other Names: Contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stacy W Gray, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): December 14, 2025
• Study Completion (Estimated): December 14, 2025

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 22261 (City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2023-01626 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No