Testing Gene PilotLX With Latinx Cancer Patients
NCT Number: NCT06476938
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer
Interventions: OTHER: Gene PilotLX
Sponsor: Fox Chase Cancer Center
Collaborators: Temple University|MD Anderson Cancer Center at Cooper|Herbert Irving Comprehensive Cancer Center|Columbia University|National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 232
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2026-12-31
Locations: MD Anderson Cancer Center at Cooper, Camden, New Jersey, 08103, United States|Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Temple University, Philadelphia, Pennsylvania, 19122, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Communication of preferences with family related to pursuing hereditary cancer risk information from TGP, 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., 1-3 month follow up|Perception of Tumor Genomic Profiling (TGP), 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., Baseline (day1) and 1-3 month follow up