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 — OTHER
    eHealth 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 PilotLX
    Gene 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 brochure
    Participants 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

Locations (4)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer Center at CooperCamdenNew Jersey08103
Andrea Nicholson, MPH
856-735-6249
Rebecca J Jaslow, MD (PRINCIPAL_INVESTIGATOR)
Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032
Erik Harden
212-305-6361
Yoanna S Pumpalova, MD (PRINCIPAL_INVESTIGATOR)
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Michael J Hall, MD,MS
215-728-2861
Yana Chertock, MA
215-214-3216
Michael J Hall, MD,MS (PRINCIPAL_INVESTIGATOR)
Temple University HospitalPhiladelphiaPennsylvania19122
Sarah B Bass, PhD, MPH
215-204-5110
Katie Singley
215- 204-1956
Sarah B Bass, PhD, MPH (PRINCIPAL_INVESTIGATOR)

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