Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476938
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
Testing Gene PilotLX With Latinx Cancer Patients
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Testing the Efficacy of an eHealth Decision Support Tool to Help Latinx Cancer Patients Make Informed Decisions About Tumor Genomic Testing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 ie 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 AABlack 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 PilotLXan 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
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 AABlack 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 PilotLXan 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54CA221705 | NIH | None | None |