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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772130
• Other study ID #: 22261
• Secondary ID: NCI-2023-0162622
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: December 14, 2025

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 14, 2025
• Est. primary completion date: December 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Best Practice
Receive family letter and genomic test report
• 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

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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