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NCT Number: NCT06476938

Testing Gene PilotLX With Latinx Cancer Patients

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Self-identified Latinx patients who:

  • diagnosed with solid tumor cancers
  • speak/read English or Spanish;
  • can provide informed consent.

Exclusion criteria

Patients with hematologic/liquid cancers (leukemia, lymphoma, multiple myeloma, etc.)

Treatment and study plan

Gene PilotLX

Other

eHealth decision making tool regarding tumor genomic profiling

Primary outcomes

  1. 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

    PrepDM 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.

  2. Decisional Conflict: Ottawa Decision Support Framework (ODSF) scale

    Time frame: Post-test (can occur on same day as baseline, day 1) and 1-3 month follow-up

    16- 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]

  3. Communication of preferences to doctor related to pursuing hereditary cancer risk information from TGP

    Time frame: 1-3 month follow up

    This 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 outcomes

  1. Communication of preferences with family related to pursuing hereditary cancer risk information from TGP

    Time frame: 1-3 month follow up

    This 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.

  2. Perception of Tumor Genomic Profiling (TGP)

    Time frame: Baseline (day1) and 1-3 month follow up

    18 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael J Hall, MD, MS

CONTACT

[email protected]

215-728-2861

Sarah B Bass, PhD, MPH

CONTACT

[email protected]

215-204-5110

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Herbert Irving Comprehensive Cancer Center
  • MD Anderson Cancer Center at Cooper
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • Temple University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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