Implementation of eHealth Delivery Alternatives for Cancer Genetic Testing for Hereditary Cancer (eREACH3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Uptake of Visit 1
研究概览
简要总结
The purpose of the study is to understand patient interest in telehealth and digital tools for pre-test genetic education and/or disclosure of genetic test results. Participants will receive telehealth genetic counseling in the home and may be offered various digital tools to help with the counseling and testing process. These are optional and participants can still speak with a genetic counselor if they wish.
详细描述
The goal of the eREACH3 Study is to evaluate the implementation of these tools into remote genetic services, evaluating uptake and use of digital tools and outcomes in representative clinical populations. The initial protocol will include two genetic counseling visits, providing comparison outcomes. Future amendments will be provided as digital tools are ready for implementation.
Specific Aim 1: (Reach) Evaluate the uptake, use and acceptability of digital delivery alternatives in remote genetic services provided as alternatives to the traditional two-visit model with a genetic counselor.
Specific Aim 2: (Effectiveness) Evaluate short-term and 6 month patient reported cognitive, affective and behavioral outcomes (2a) with remote genetic services and digital alternatives in representative clinical populations and moderators of outcomes (2b).
Specific Aim 3: (Implementation) Evaluate provider time associated with implementation of remote telehealth services and digital delivery alternatives and barriers and facilitators to future clinical implementation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •18 years of age or older
- •Speak and understand English
- •Meet current National Comprehensive Cancer Network (NCCN) or other national guidelines for germline genetic testing or are interested in genetic counseling based on personal or family history of cancer. Patients with prior genetic testing are eligible if they meet criteria for updated testing, or if post-test genetic counseling services are requested.
排除标准
- •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
研究组 & 干预措施
Visit 1
All participants will be offered remote telehealth Visit 1 services by telephone or real-time videoconference or by a chatbot (patient choice).
结局指标
主要结局
Uptake of Visit 1
时间窗: Through 6 months
Participant completion of Visit 1 (yes/no)
Uptake of Digital Visit 1
时间窗: Through 6 months
Participant completion of digital intervention as an alternative for Visit 1 (yes/no)
Uptake of genetic testing
时间窗: Through 6 months
Participant completion of genetic testing and received results/Visit 2 (yes/no)
次要结局
- The KnowGene Scale(Through study completion, an average of 6 months)
- Test result recall(Through study completion, an average of 6 months)
- Impact of Events Scale (IES)(Through study completion, an average of 6 months)
- Satisfaction with genetic services(Through study completion, an average of 6 months)
- Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA)(Through study completion, an average of 6 months)
- Decisional Regret Scale(Through study completion, an average of 6 months)