Trial Title:
Testing Gene PilotLX With Latinx Cancer Patients
NCT ID:
NCT06476938
Condition:
Cancer
Conditions: Keywords:
eHealth decision tool
Hispanic/Latino
Tumor Genomic Profiling
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Gene PilotLX
Description:
eHealth decision making tool regarding tumor genomic profiling
Arm group label:
Gene PilotLX
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.
Criteria for eligibility:
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.)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center at Cooper
Address:
City:
Camden
Zip:
08103
Country:
United States
Contact:
Last name:
Andrea Nicholson, MPH
Phone:
856-735-6249
Email:
nicholson-andrea@CooperHealth.edu
Investigator:
Last name:
Rebecca J Jaslow, MD
Email:
Principal Investigator
Facility:
Name:
Herbert Irving Comprehensive Cancer Center
Address:
City:
New York
Zip:
10032
Country:
United States
Contact:
Last name:
Erik Harden
Phone:
212-305-6361
Email:
eh2828@cumc.columbia.edu
Investigator:
Last name:
Yoanna S Pumpalova, MD
Email:
Principal Investigator
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Contact:
Last name:
Michael J Hall, MD,MS
Phone:
215-728-2861
Email:
michael.hall@fccc.edu
Contact backup:
Last name:
Yana Chertock, MA
Phone:
215-214-3216
Email:
yana.chertock@fccc.edu
Investigator:
Last name:
Michael J Hall, MD,MS
Email:
Principal Investigator
Facility:
Name:
Temple University
Address:
City:
Philadelphia
Zip:
19122
Country:
United States
Contact:
Last name:
Sarah B Bass, PhD, MPH
Phone:
215-204-5110
Email:
sbass@temple.edu
Contact backup:
Last name:
Katie Singley
Phone:
215- 204-1956
Email:
katie.singley@temple.edu
Investigator:
Last name:
Sarah B Bass, PhD, MPH
Email:
Principal Investigator
Start date:
September 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
Temple University
Agency class:
Other
Collaborator:
Agency:
MD Anderson Cancer Center at Cooper
Agency class:
Other
Collaborator:
Agency:
Herbert Irving Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06476938
