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NCT Number: 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

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.

Recruiting

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Hereditary Malignant Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location status: Recruiting

Location contact

Stacy W. Gray

CONTACT

[email protected]

626-218-8662

Stacy W. Gray

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive family letter and genomic test report

Other names: standard of care, standard therapy

Electronic Health Record Review

Other

Ancillary studies

Personal Contact

Behavioral

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

Other names: Contact

Survey Administration

Other

Ancillary studies

Primary outcomes

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

    Time frame: Up to 9 months after enrollment

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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