Gene PilotLX decision tool for Latinx people with cancer
Testing the Efficacy of an eHealth Decision Support Tool to Help Latinx Cancer Patients Make Informed Decisions About Tumor Genomic Testing
This study tests an electronic, bilingual decision tool called Gene PilotLX to help Latinx people with solid tumors decide what to do about hereditary-risk information that can come from tumor genomic profiling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fox Chase Cancer Center Academic / other |
| Locations | 4 sites (Camden, New Jersey and 3 other locations) |
| Trial ID | NCT06476938 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial gives eligible Latinx patients either the Gene PilotLX eHealth decision tool or usual care to see how the tool affects informed decision-making about secondary hereditary findings from tumor genomic profiling. The intervention is bilingual and culturally tailored to address factors such as familismo, fatalismo, language barriers, and medical mistrust. Outcomes include patient knowledge, decisional conflict, preferences (opt out vs. pursue genetic counseling), and uptake of follow-up genetic services. The trial recruits self-identified Latinx adults with solid tumors who read English or Spanish and excludes hematologic cancer patients.
Who should consider this trial
Good fit: Self-identified Latinx adults with solid tumor cancers who speak or read English or Spanish and can provide informed consent are the intended participants.
Not a fit: Patients with hematologic (blood) cancers, non-Latinx individuals, or people unable to read English or Spanish are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, Gene PilotLX could help Latinx patients better understand hereditary risk information from tumor tests and make decisions that match their values, potentially increasing appropriate use of genetic counseling.
How similar studies have performed: While eHealth decision aids have improved decision quality in other settings, few trials have tested culturally and linguistically tailored tools for Latinx patients facing tumor genomic profiling, making this approach relatively novel for this group.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Self-identified Latinx patients who: 1. diagnosed with solid tumor cancers 2. speak/read English or Spanish; 3. can provide informed consent. Exclusion Criteria: Patients with hematologic/liquid cancers (leukemia, lymphoma, multiple myeloma, etc.)
Where this trial is running
Camden, New Jersey and 3 other locations
- MD Anderson Cancer Center at Cooper — Camden, New Jersey, United States (Not_yet_recruiting)
- Herbert Irving Comprehensive Cancer Center — New York, New York, United States (Not_yet_recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Temple University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael J Hall, MD,MS — Fox Chase Cancer Center
- Study coordinator: Michael J Hall, MD, MS
- Email: michael.hall@fccc.edu
- Phone: 215-728-2861
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.