Cancer
Conditions
Brief summary
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.
Interventions
OTHERInteractive Chatbot
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.
Sponsors
Abramson Cancer Center at Penn Medicine
Emory University
Baylor College of Medicine
Fox Chase Cancer Center
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of digital pre-test chatbot | 6 months from consent | Participant completion of digital intervention as an alternative for pre-test counseling (yes/no) |
| Uptake of genetic testing | 6 months from consent | Participant completion of genetic testing (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Understanding of Genetic Information | Change from Baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results | 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 |
| General anxiety and Depression | Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results | Will be measured by the 4-item each short Patient Reported Outcomes Measurement Information System (PROMIS) measures |
| Reactions to genetic information | Change from baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results | Will be measured using an 8-item Impact of Events Scale (IES) |
| Satisfaction with genetic services | Within 7 days post-education, and within 7 days after disclosure of genetic test results | Will be assessed with a 14-items evaluating satisfaction with genetic services |
| Psychosocial impact of returning genomic findings | Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results | Evaluation of distress, uncertainty and positive responses to receipt of genetic test results using 17 items from the MICRA (Multi-dimensional Impact of Cancer Risk Assessment Questionnaire) |
| Decisional regret | Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results | Evaluated using 5-item validated Decision Regret Scale |
Countries
United States
Outcome results
None listed