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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Hematopoietic and Lymphoid System Neoplasm, Hereditary Malignant Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Other: Best Practice
* Other: Electronic Health Record Review
* Behavioral: Personal Contact
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study. | Other: Best Practice<br>* Receive family letter and genomic test report<br>* Other names: standard therapy;Other: Electronic Health Record Review<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (provider-mediated contact)<br>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<br>* Ancillary studies<br>Behavioral: Personal Contact<br>* Receive family letter and genomic test report with provider-mediated contact<br>* Other names: Contact;Other: Survey Administration<br>* Ancillary studies<br>|

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 |