Testing Gene PilotLX With Latinx Cancer Patients
Part of paid clinical trials in Camden, New Jersey.
- Sponsor
- Fox Chase Cancer Center
- Study ID
- NCT06476938
- Status
- Recruiting
Conditions
- Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Gene PilotLX — OTHEReHealth decision making tool regarding tumor genomic profiling
Study Details
This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase informed decision making regarding hereditary risk information from tumor genomic profiling (TGP) test among Latinx cancer patients recruited at four cancer centers.
Key Dates
- Start date
- May 30, 2025
- Status verified
- Jun 2025
- Primary completion
- May 1, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 232 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Gene PilotLXGene PilotLX is an eHealth decision support tool that is designed to empower Latinx cancer patients to decide their preferences for learning about secondary genetic information, communicate those preferences to their doctors, and provide the opportunity to discuss information with their families or others to feel they have made an informed decision. The tool will be available in both English and Spanish. It is web-based, has a voice-over, and is easy to navigate, with simple forward and backward buttons. Each section includes a different aspect of tumor genomic profiling, from basic information about what the test is and what the pros and cons are of the test, to culturally specific potential barriers or benefits to learning hereditary results. At the end, the tool provides tailored potential questions for a doctor that users can choose, which are summarized in a "score card" that can be printed or emailed.
- No Intervention: TGP brochureParticipants in the control arm will be provided a brochure about tumor genomic profiling (TGP) secondary hereditary risks, and what patients can decide about getting that information, including the pros and cons. It is literacy appropriate, incorporates visuals, and will also be offered in both English and Spanish.
Primary Outcome Measure
Preparation for Decision Making (PrepDM) Scale [ Time Frame: Post-test (can occur on same day as baseline, day 1) and 1-3 month follow-up ]
Central Contacts
- Michael J Hall, MD, MS215-728-2861
- Sarah B Bass, PhD, MPH215-204-5110
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center at Cooper | Camden | New Jersey | 08103 | Rebecca J Jaslow, MD (PRINCIPAL_INVESTIGATOR) |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Yoanna S Pumpalova, MD (PRINCIPAL_INVESTIGATOR) |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Michael J Hall, MD,MS (PRINCIPAL_INVESTIGATOR) |
| Temple University Hospital | Philadelphia | Pennsylvania | 19122 | Sarah B Bass, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
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