A study comparing two methods for genetic testing in families at risk for hereditary cancer
CHARGE: CHOICE ARCHITECTURE IN GENETIC TESTING
NA · University of Texas Southwestern Medical Center · NCT06284330
This study is testing whether sending genetic testing kits directly to family members at risk for hereditary cancer helps them get tested more than just offering standard counseling.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06284330 on ClinicalTrials.gov |
What this trial studies
The CHARGE study evaluates the effectiveness of a choice architecture intervention for cascade genetic testing compared to usual care. It consists of two arms: one providing standard genetic counseling and education, and the other mailing home genetic testing kits directly to at-risk relatives of probands. This approach aims to enhance participation in genetic testing and improve awareness of hereditary cancer risks. The study focuses on individuals with specific pathogenic variants and their relatives, all residing in Texas.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a newly reported pathogenic variant in specific cancer-related genes and at least one adult living genetically related relative in Texas.
Not a fit: Patients who have been referred for genetic testing by a relative with a pathogenic variant or who are unwilling to participate in the randomization process may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to genetic testing for families at risk of hereditary cancer, leading to earlier detection and better management of cancer risks.
How similar studies have performed: While the approach of using choice architecture in genetic testing is innovative, similar studies have shown promise in enhancing patient engagement and testing uptake.
Eligibility criteria
Show full inclusion / exclusion criteria
Proband Inclusion Criteria: * Have a newly reported pathogenic or likely pathogenic variant in one or more of the following genes: APC, ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, PTEN, TP53 * 18 years of age or older * English fluency * Have at least 1 adult living genetically related relative who resides in Texas Proband Exclusion Criteria: * Referred for genetic testing by a relative with a pathogenic variant * Unwilling to be randomized to a study arm Relative Inclusion Criteria: * 18 years of age or older * English fluency * Residing in Texas
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Sukh Makhnoon, PhD, MS — UT Southwestern Medical Center
- Study coordinator: Sukh Makhnoon, PhD, MS
- Email: Chargestudy@utsouthwestern.edu
- Phone: 214-638-3242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hereditary Cancer, cascade genetic testing, hybrid type I, feasibility