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Testing Gene PilotLX With Latinx Cancer Patients

Testing the Efficacy of an eHealth Decision Support Tool to Help Latinx Cancer Patients Make Informed Decisions About Tumor Genomic Testing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06476938
Enrollment
239
Registered
2024-06-27
Start date
2025-05-30
Completion date
2026-11-30
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

eHealth decision tool, Hispanic/Latino, Tumor Genomic Profiling

Brief summary

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.

Detailed description

The use of multi-gene tumor genomic profiling (TGP) to examine a patient's tumor for targetable mutations is a cornerstone of personalized oncology. Providers are required to communicate TGP risks to patients and elicit patient preferences for managing information (i.e., "opt out" or have genetic counseling) because of the possibility of uncovering secondary hereditary cancer risks found on this test. Yet barriers exist to support optimal decision-making. Limited study of genetic links to cancer has been done with Latinx patients making them an important understudied group to target for genetic decision support. Shared cultural values among Latinx individuals such as familismo (family loyalty) and fatalismo (fatedness) may influence how patients approach cancer risk assessment and genetics and language and acculturation barriers, access and affordability, deportation risks, medical mistrust and low genetic knowledge impact decision making. As a result, Latinx patients are less likely to participate in clinical genetic testing. Adding to this vulnerability is the fact that many oncologists may not have a good understanding of how to effectively communicate secondary hereditary risks to Latinx patients. This leaves Latinx patients without the support they need to make good decisions about what they would want to do about secondary results from TGP that is in line with their needs, preferences and values. eHealth interventions can promote health behavior change when developed with targeted messages, but many fall short if they do not effectively address the core barriers to a health decision. Gene PilotLX was developed using commercial marketing techniques to ensure saliency. Using perceptual mapping and vector message modeling, the investigators have shown in our parent Gene Pilot study that was conducted among AA/Black cancer patients that this approach provides a superior methodology for developing effective, persuasive messages that result in significant behavior and decisional conflict changes. A fully powered randomized controlled trial will be conducted with 232 Latinx cancer patients at four oncology sites to evaluate the efficacy of Gene PilotLX,an electronic health decision support tool. Participants will be randomized either to intervention arm and watch Gene PilotLX or usual arm and review patient information about TGP presented in a written document (pdf). All participants will complete three assessments: baseline, immediate post intervention, and 1-3-month surveys.

Interventions

OTHERGene PilotLX

eHealth decision making tool regarding tumor genomic profiling

Sponsors

Fox Chase Cancer Center
Lead SponsorOTHER
Temple University
CollaboratorOTHER
MD Anderson Cancer Center at Cooper
CollaboratorOTHER
Herbert Irving Comprehensive Cancer Center
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Preparation for Decision Making (PrepDM) ScalePost-test (can occur on same day as baseline, day 1) and 1-3 month follow-upPrepDM Scale measures preparedness of patient to make a decision (10 items) regarding a hereditary risk from tumor genomic profiling (TGP) on a 1 "not at all" to 5 "a great deal" scale. Higher means indicated higher perceived level of preparation for decision making.
Decisional Conflict: Ottawa Decision Support Framework (ODSF) scalePost-test (can occur on same day as baseline, day 1) and 1-3 month follow-up16- item measure to determine patient clarity on the risks and benefits of tumor genomic profiling (TGP) testing and hereditary risk information from TGP. Items are given a score value of: 0= 'strongly agree'; 2= 'neither agree nor disagree'; 3= 'disagree'; 4= 'strongly disagree' TOTAL SCORE 16 items are: a) summed; b) divided by 16; and c) multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]
Communication of preferences to doctor related to pursuing hereditary cancer risk information from TGP1-3 month follow upThis is a single dichotomous item created for the study: 'Have you talked with a doctor about secondary hereditary results from TGP testing'?('Yes', 'No'). If 'Yes' is selected, 7 different topics for discussion with doctor are listed, including 'other' as open question.

Secondary

MeasureTime frameDescription
Communication of preferences with family related to pursuing hereditary cancer risk information from TGP1-3 month follow upThis is a single dichotomous item created for the study: 'Have you talked about secondary hereditary results from TGP testing with your family, friends or spouse/partner'? ('Yes', 'No'). If 'Yes' is selected, 7 different topics for discussion with family are listed, including 'other' as open question.
Perception of Tumor Genomic Profiling (TGP)Baseline (day1) and 1-3 month follow up18 statements related to benefits and concerns of TGP were developed as part of formative work (focus group with patients) for our previous work with AA/Black cancer patients and are related to beliefs, perceived barriers and benefits of TGP testing; 0-10 agreement scale when 0 is 'strongly disagree' and 10 'strongly agree'. Perceptual maps will be generated from the survey responses. Perceptual mapping methods developed by co-PI Bass use multidimensional scaling (MDS) analysis to create 3-Dimensional representations of how participants conceptualizes a decision and then message vector modeling techniques are used to design messages that will be most likely to persuade participants to make that decision. This method will be used to design messages for Gene PilotLX, the eHealth decision aid for Latinx cancer patients.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael J Hall, MD,MS

Fox Chase Cancer Center

PRINCIPAL_INVESTIGATORSarah B Bass, PhD, MPH

Temple University

PRINCIPAL_INVESTIGATORTracey A Revenson, PhD

Hunter College of City University of New York

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026