Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772130
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-03-06
Brief Title:
Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients to Improve Genetic Counseling and Testing Rates Family HOPE Study
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Family HOPE Study Hereditary Lynch Syndrome Opportunities for Participation Amp Engagement
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons risk for developing cancer Most people who have an inherited harmful change in a cancer risk gene dont 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 doesnt 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-01626 | REGISTRY | None | None |
| 22261 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |