Overcoming Barriers to the Uptake of Cascade Screening for Lynch Syndrome: Workbook Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability of Workbook Assessed Through Likert Score Scale
研究概览
简要总结
The investigators will evaluate the feasibility of an intervention to improve Lynch syndrome cascade screening uptake. The investigators will conduct a pilot study among 15 patients diagnosed with Lynch Syndrome and 5 genetic counselors to assess the feasibility and intermediate outcomes of an educational workbook containing exercises and resources to improve family communication among individuals with Lynch Syndrome and first-degree relatives of individuals with Lynch Syndrome.
详细描述
Genetic counselors of patients with Lynch Syndrome and patients with Lynch Syndrome will test a planning tool (referred to as an educational workbook) for cascade screening. Five genetic counselors and 15 patients with Lynch Syndrome will be recruited from the UNC Health System and the Ohio State Comprehensive Cancer Center. Genetic counselors will identify patients with Lynch Syndrome and introduce the study opportunity to potential patient participants. All patients and genetic counselors will complete a telephone enrollment call and provide informed consent to participate. Enrolled patients will work with enrolled genetic counselors to complete the first workbook exercise and then patients will complete the remaining exercises alone for over approximately 1 month. After genetic counselors and patients have completed using the workbook, the investigators will conduct qualitative virtual interviews over Zoom and a post-intervention electronic survey to understand the participants' experiences using the workbook. The investigators aim to understand the feasibility of using the workbook as an intervention in clinical practice to improve genetic testing uptake in families with Lynch Syndrome.
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
盲法说明
No masking
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
- •Patients must have been diagnosed with Lynch Syndrome within the last 365 days.
- •Patients and genetic counselors must be age 18 or older.
- •Patients must be receiving care from genetic counselors at Ohio State University Comprehensive Cancer Center or at UNC Health System.
- •Genetic counselors must provide Lynch Syndrome counseling for patient participants at Ohio State University Comprehensive Cancer Center or at UNC Health System.
- •Patients and genetic counselors must be able to speak and read in English.
- •Patients and genetic counselors must review informed consent documents and provide verbal consent to participate in the study.
排除标准
- •There are no exclusion criteria for study participants.
结局指标
主要结局
Acceptability of Workbook Assessed Through Likert Score Scale
时间窗: Post 4 Weeks of Workbook Use
Participants evaluated the workbook using seven acceptability criteria rated on a 5-point Likert scale, where 1 indicated "Strongly Disagree" and 5 indicated "Strongly Agree." The criteria assessed ease of use, clarity of exercises, enjoyment, usefulness for understanding Lynch Syndrome, support for communicating genetic information, time acceptability, and overall satisfaction. Each participant's responses were summed up to produce a total acceptability score ranging from 7 to 35, with higher scores indicating greater acceptability. A score of 28 or higher (80% of the maximum score, which was 35) was defined as an acceptable intervention.
次要结局
未报告次要终点