Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Shared Decision Making Process Scores
研究概览
简要总结
This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer
详细描述
The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:
- Knowledge Survey
- Shared Decision Making Process Survey
- Decisional Conflict Scale
The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.
The National Cancer Institute (NCI) is supporting this research study by providing funding for the research
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •18 years or older
- •Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
- •Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.
- •Exclusion Criteria :
- •Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
- •Previous germline genetic testing
- •History of hereditary pancreatitis
- •Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults
排除标准
- 未提供
结局指标
主要结局
Shared Decision Making Process Scores
时间窗: 1 week after genetics session
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.
Average change in knowledge survey score
时间窗: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
Decisional Conflict Scores
时间窗: 1 week after genetics session
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
次要结局
- Average time between genetic testing recommendation and sample collection(Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months)
- Average Duration of Decision Making Process(Approximately 30 minutes - 1 hour)
- Ratio of the number of participants who chose each of the three panels offered(At the conclusion of genetics session (day 1))
- Percentage of participants choosing genetic testing(At the conclusion of genetics session (day 1))
研究者
Daniel C Chung
Principal Investigator
Massachusetts General Hospital