Testing Gene PilotLX With Latinx Cancer Patients

NCT06476938 | Recruiting

• 2 other identifiers: 23-1047U54CA221705
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 4

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.

Conditions

Cancer

Keywords

eHealth decision tool; Hispanic/Latino; Tumor Genomic Profiling

Outcome Measures

Primary Outcomes (3)

• Preparation for Decision Making (PrepDM) Scale

  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.

  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

  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 \[extremely high decisional conflict\]

  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

  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.

  1-3 month follow up

Secondary Outcomes (2)

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

  1-3 month follow up

• Perception of Tumor Genomic Profiling (TGP)

  Baseline (day1) and 1-3 month follow up

Study Arms (2)

Gene PilotLX

EXPERIMENTAL

Gene PilotLX is an eHealth decision support tool that is designed to empower Latinx cancer patients to decide their preferences for learning about secondary genetic information, communicate those preferences to their doctors, and provide the opportunity to discuss information with their families or others to feel they have made an informed decision. The tool will be available in both English and Spanish. It is web-based, has a voice-over, and is easy to navigate, with simple forward and backward buttons. Each section includes a different aspect of tumor genomic profiling, from basic information about what the test is and what the pros and cons are of the test, to culturally specific potential barriers or benefits to learning hereditary results. At the end, the tool provides tailored potential questions for a doctor that users can choose, which are summarized in a "score card" that can be printed or emailed.

Other: Gene PilotLX

TGP brochure

NO INTERVENTION

Participants in the control arm will be provided a brochure about tumor genomic profiling (TGP) secondary hereditary risks, and what patients can decide about getting that information, including the pros and cons. It is literacy appropriate, incorporates visuals, and will also be offered in both English and Spanish.

Interventions

Gene PilotLX OTHER

eHealth decision making tool regarding tumor genomic profiling

Gene PilotLX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified Latinx patients who:
• diagnosed with solid tumor cancers
• speak/read English or Spanish;
• can provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (4)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

NOT YET RECRUITING

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

NOT YET RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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. Erratum In: JAMA Oncol. 2016 Feb;2(2):279. doi: 10.1001/jamaoncol.2015.6541.. Hyman, David [corrected to Hyman, David M].

  PMID: 26556299 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Wilson J, Heinsch M, Betts D, Booth D, Kay-Lambkin F. Barriers and facilitators to the use of e-health by older adults: a scoping review. BMC Public Health. 2021 Aug 17;21(1):1556. doi: 10.1186/s12889-021-11623-w.

  PMID: 34399716 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Michael J Hall, MD,MS

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Sarah B Bass, PhD, MPH

  Temple University

  PRINCIPAL INVESTIGATOR

• Tracey A Revenson, PhD

  Hunter College of City University of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Hall, MD, MS

CONTACT

215-728-2861; michael.hall@fccc.edu

Sarah B Bass, PhD, MPH

CONTACT

215-204-5110; sbass@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 27, 2024
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)