Testing Gene PilotLX With Latinx Cancer Patients

Official title

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

Overview

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

• Other Gene PilotLX
  eHealth decision making tool regarding tumor genomic profiling

Primary outcome measures

• 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]
• 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]
• Communication of preferences to doctor related to pursuing hereditary cancer risk information from TGP [Time frame: 1-3 month follow up]

Secondary outcome measures (2)

• Communication of preferences with family related to pursuing hereditary cancer risk information from TGP [Time frame: 1-3 month follow up]
• Perception of Tumor Genomic Profiling (TGP) [Time frame: Baseline (day1) and 1-3 month follow up]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 4 centers

• MD Anderson Cancer Center at Cooper — Camden
• Herbert Irving Comprehensive Cancer Center — New York
• Fox Chase Cancer Center — Philadelphia
• Temple University Hospital — Philadelphia

Publications

• Catenacci DV, Amico AL, Nielsen SM, Geynisman DM, Rambo B, Carey GB, Gulden C, Fackenthal J, Marsh RD, Kindler HL, Olopade OI. Tumor genome analysis includes germline genome: are we ready for surprises? Int J Cancer. 2015 Apr 1;136(7):1559-67. doi: 10.1002/ijc.29128. Epub 2014 Aug 14. PMID 25123297
• Schrader KA, Cheng DT, Joseph V, Prasad M, Walsh M, Zehir A, Ni A, Thomas T, Benayed R, Ashraf A, Lincoln A, Arcila M, Stadler Z, Solit D, Hyman DM, Zhang L, Klimstra D, Ladanyi M, Offit K, Berger M, Robson M. Germline Variants in Targeted Tumor Sequencing Using Matched Normal DNA. JAMA Oncol. 2016 Jan;2(1):104-11. doi: 10.1001/jamaoncol.2015.5208. PMID 26556299
• Cruz-Correa M, Perez-Mayoral J, Dutil J, Echenique M, Mosquera R, Rivera-Roman K, Umpierre S, Rodriguez-Quilichini S, Gonzalez-Pons M, Olivera MI, Pardo S; Puerto Rico Clinical Cancer Genetics Consortia. Clinical Cancer Genetics Disparities among Latinos. J Genet Couns. 2017 Jun;26(3):379-386. doi: 10.1007/s10897-016-0051-x. Epub 2016 Dec 12. PMID 27957667
• Lynce F, Graves KD, Jandorf L, Ricker C, Castro E, Moreno L, Augusto B, Fejerman L, Vadaparampil ST. Genomic Disparities in Breast Cancer Among Latinas. Cancer Control. 2016 Oct;23(4):359-372. doi: 10.1177/107327481602300407. PMID 27842325
• Pagan JA, Su D, Li L, Armstrong K, Asch DA. Racial and ethnic disparities in awareness of genetic testing for cancer risk. Am J Prev Med. 2009 Dec;37(6):524-30. doi: 10.1016/j.amepre.2009.07.021. PMID 19944919
• Canedo JR, Miller ST, Myers HF, Sanderson M. Racial and ethnic differences in knowledge and attitudes about genetic testing in the US: Systematic review. J Genet Couns. 2019 Jun;28(3):587-601. doi: 10.1002/jgc4.1078. Epub 2019 Jan 21. PMID 30663831
• Furness K, Sarkies MN, Huggins CE, Croagh D, Haines TP. Impact of the Method of Delivering Electronic Health Behavior Change Interventions in Survivors of Cancer on Engagement, Health Behaviors, and Health Outcomes: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Jun 23;22(6):e16112. doi: 10.2196/16112. PMID 32574147
• Wagner LI, Tooze JA, Hall DL, Levine BJ, Beaumont J, Duffecy J, Victorson D, Gradishar W, Leach J, Saphner T, Sturtz K, Smith ML, Penedo F, Mohr DC, Cella D. Targeted eHealth Intervention to Reduce Breast Cancer Survivors' Fear of Recurrence: Results From the FoRtitude Randomized Trial. J Natl Cancer Inst. 2021 Nov 2;113(11):1495-1505. doi: 10.1093/jnci/djab100. PMID 34057469

Identifiers

NCT: NCT06476938 · 23-1047 · U54CA221705

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗