Enrolling by invitation NCT07517666
Genetic Information for Families After Tumor Testing Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interactive Chatbot.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Genetic Information for Families After Tumor Testing (GIFTT) Study
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.
Interventions
- Other Interactive 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.
Primary outcome measures
- Uptake of digital pre-test chatbot [Time frame: 6 months from consent]
- Uptake of genetic testing [Time frame: 6 months from consent]
Secondary outcome measures (6)
- Understanding of Genetic Information [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 [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 [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 [Time frame: Within 7 days post-education, and within 7 days after disclosure of genetic test results]
- Psychosocial impact of returning genomic findings [Time frame: Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results]
- Decisional regret [Time frame: Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07517666 · 05026