NCT07517666Enrolling By Invitation不适用
Genetic Information for Families After Tumor Testing (GIFTT) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Uptake of digital pre-test chatbot
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Uptake of digital pre-test chatbot
时间窗: 6 months from consent
Participant completion of digital intervention as an alternative for pre-test counseling (yes/no)
Uptake of genetic testing
时间窗: 6 months from consent
Participant completion of genetic testing (yes/no)
次要结局
- 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)
- 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)
- 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)
- 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(Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results)
- Decisional regret(Within 7 days after disclosure of genetic test results, and at 6 months after disclosure of genetic test results)
研究者
研究点 (1)
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