Testing Gene PilotLX With Latinx Cancer Patients

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFox Chase Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosed with solid tumor cancers

speak/read English or Spanish;

can provide informed consent.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gene PilotLX

    Other intervention

    eHealth decision making tool regarding tumor genomic profiling

Treatment groups

232 Participants
are divided into 2 treatment groups
Group A: Gene PilotLXExperimental treatment 1 intervention
Group B: TGP brochureNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Post-test (can occur on same day as baseline, day 1) and 1-3 month follow-up
2

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 \[extremely high decisional conflict\]

Time frame
Post-test (can occur on same day as baseline, day 1) and 1-3 month follow-up
3

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.

Time frame
1-3 month follow up

Secondary outcomes

1

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.

Time frame
1-3 month follow up
2

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.

Time frame
Baseline (day1) and 1-3 month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fox Chase Cancer Center

Lead sponsor

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