Genetic Information for Families After Tumor Testing Study

N/AEnrolling By InvitationNCT07517666

Abramson Cancer Center at Penn Medicine100 enrolled

Overview

The purpose of this study is to develop and implement a methodology of digital tools paired with telemedicine to improve cascade testing for clinically significant germline mutations among family members of children with cancer who have a pathogenic or likely pathogenic(P/LP) germline variant in a cancer predisposition gene.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Cancer

Interventions

Interactive ChatbotOTHER

The chatbot intervention will provide biological parents the option to complete pre-test education using an interactive chatbot as an alternative to remote counseling with a genetic counselor. This interactive chatbot will provide opportunities for longitudinal educational and information support, reminders for scheduling next steps, and the option to send specific questions to the genetic counseling team.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Biological parent of a child enrolled in the ORIGen cohort (AEPI24N1) who has a confirmed P/LP germline variant in a CPG. * 18 years of age or older. * Speak and understand English. Exclusion Criteria: * Previous genetic testing for the familial variant. * Communication difficulties such as: * Uncorrected or uncompensated hearing and/or vision impairment. Patients who can successfully use clinical assistance devices are not excluded. * Uncorrected or uncompensated speech defects. Patients who can successfully use clinical assistance devices are not excluded. * Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks.

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Uptake of digital pre-test chatbot

Participant completion of digital intervention as an alternative for pre-test counseling (yes/no)

Time frame: 6 months from consent

Uptake of genetic testing

Participant completion of genetic testing (yes/no)

Time frame: 6 months from consent

Secondary Outcomes

Understanding of Genetic Information

Will be evaluated using an adapted version of the KnowGene Scale, a 16-item scale administered to patients after genetic testing and/or genetic counseling to measure their understanding of the health implications of genetic testing results

Time frame: Change from Baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results

General anxiety and Depression

Will be measured by the 4-item each short Patient Reported Outcomes Measurement Information System (PROMIS) measures

Time frame: Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results

Reactions to genetic information

Will be measured using an 8-item Impact of Events Scale (IES)

Time frame: Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results

Satisfaction with genetic services

Will be assessed with a 14-items evaluating satisfaction with genetic services

Time frame: Within 7 days post-education, and within 7 days after disclosure of genetic test results

Data from ClinicalTrials.gov

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