OPTimizing Treatment Focused Genetic Testing IN Cancer - OPT-IN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Satisfaction with pre-genetic test education
研究概览
简要总结
This two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test Chatbot education.
详细描述
In this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: Chatbot and video education.
The first part of this research study is a Pilot Study, which is the first-time investigators are examining the use of a Chatbot to deliver pre-genetic test education. The Chatbot will converse with you about germline genetic testing by text message.
The Pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling.
The second part of this research study will utilize findings from the Pilot Study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer.
In both parts of this research study, participants will be randomized to either the video education or Chatbot. Participants may request in-person genetic counseling after their respective education prior to testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Adult patients over the age of 18
- •With a diagnosis of advanced cancer (defined as Stage 3 or 4), or
- •Any stage for pancreatic cancer and
- •No prior cancer genetic panel testing
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women (if known at the time of participation)
- •Prisoners
- •Non-English speakers
结局指标
主要结局
Satisfaction with pre-genetic test education
时间窗: at time of post-counseling/video pre-result disclosure, on average 3 weeks
A validated survey of participants' satisfaction with the genetic counseling and testing process will be used. For the survey at the time of post-counseling, the survey for the video education arm consists of 8 questions and the genetic counseling arm contains an additional question about perceived length of the visit. The parameters for measurement are "disagree strongly", "disagree", "neither agree or disagree", "agree", and "agree strongly".
The measurement of genetic testing uptake
时间窗: 2 years
The proportion of participants who consent to genetic testing in each study arm
Meaningful cancer treatment changes
时间窗: 2 years
Assessed by chart review. Participants with positive genetic test results will be reviewed for changes in cancer treatment.
次要结局
- Intent to disclose genetic test results(1 day (at time of intervention))
- Communication of results with family members(4 months post-result disclosure)
- Decisional regret(4 months post-result disclosure)
- Knowledge of multi-gene panel testing(1 day (at the time of intervention))
- Cascade testing of family members(6 month post-result disclosure)
研究者
Huma Rana, MD
Principal Investigator
Dana-Farber Cancer Institute