Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Emory University | OTHER |
| Baylor College of Medicine | OTHER |
| Fox Chase Cancer Center | OTHER |
| National Cancer Institute (NCI) |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Genetic counseling via digital tools and telemedicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Chatbot | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of digital pre-test chatbot | Participant completion of digital intervention as an alternative for pre-test counseling (yes/no) | 6 months from consent |
| Uptake of genetic testing | Participant completion of genetic testing (yes/no) | 6 months from consent |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline to within 7 days post-education, and from baseline to 6 months after disclosure of genetic test results |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Previous genetic testing for the familial variant.
Communication difficulties such as:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| NIH |
| Dana-Farber Cancer Institute | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| General anxiety and Depression | Will be measured by the 4-item each short Patient Reported Outcomes Measurement Information System (PROMIS) measures | 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) | 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 | Within 7 days post-education, and within 7 days after disclosure of genetic test results |
| Psychosocial impact of returning genomic findings | 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) | Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results |
| Decisional regret | Evaluated using 5-item validated Decision Regret Scale | Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results |