A Randomized Controlled Pilot Trial of a Behavioral Intervention to Increase Uptake of Genetic Services Among Relatives at Risk of Lynch Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Feasibility (recruitment and retention rates, completeness of assessment data)
研究概览
简要总结
The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an information letter plus a booklet. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.
详细描述
Lynch syndrome runs in families. It increases the risk of many types of cancer. Pre-test genetic counseling is an opportunity for at-risk people to determine whether genetic testing is right for them. Genetic testing looks for harmful changes in the genes known to cause Lynch syndrome. However, Lynch syndrome is underdiagnosed and uptake of genetic counseling and testing is low, missing opportunities for cancer prevention and early treatment.
This study is a 2-arm randomized controlled pilot trial. We aim to recruit 48 relatives at risk of LS (from about 137 probands) and randomize them to receive either the an information letter or an information letter plus a booklet. Only one relative will be enrolled per family. The primary aim of this pilot trial is to evaluate and optimize feasibility of the trial methods and the education materials to prepare for a fully powered randomized controlled trial. A brief exit interview will be conducted at 6-months post-randomization to gather any feedback about the study methods. Reasons of those who refuse to participate or drop out of the study will be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •English speaking
- •at least 18 years old
- •have had genetic testing for Lynch syndrome (LS)
- •do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)
- •Clinical Trial Participants Inclusion Criteria:
- •English-speaking
- •at least 18 years old
- •a blood relative of a patient who was diagnosed with LS
- •potentially at risk for LS
- •have not scheduled or had pre-test genetic counseling or genetic testing for LS
- •do not have a personal history of a cancer (excluding non-melanoma skin cancer)
- •do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)
排除标准
- 未提供
研究组 & 干预措施
Information Letter
This arm provides an information letter about Lynch syndrome and genetic services.
干预措施: Information Letter (Behavioral)
Information Letter and Booklet
This arm provides an information letter with a booklet about Lynch syndrome and genetic services.
干预措施: Information Letter and Booklet (Behavioral)
结局指标
主要结局
Feasibility (recruitment and retention rates, completeness of assessment data)
时间窗: (recruitment) baseline, 1-month and 6-months post-randomization
Record the numbers of probands approached, probands enrolled, probands who provide contact information of at least one potentially eligible relative, relatives approached, enrolled, and completing each phase of the study. Calculate the percentage of complete data for those participants who complete each assessment period.
Use and attitudes towards the education materials
时间窗: 1-month post-randomization (may also include in 6-month post-randomization
Assess the extent to which participants reviewed the information letter and booklet and their attitudes, likelihood of sharing the materials, feedback on the materials and impact on decisions, how the information should be delivered.
Scheduling and attendance of pre-test genetic counseling and/or genetic testing
时间窗: 6-months post-randomization
Record whether participants scheduled or attended pre-test genetic counseling and genetic testing to calculate the proportion of genetic services uptake.
次要结局
- Scheduling and attendance of pre-test genetic counseling and/or genetic testing(1-month post-randomization)
研究者
Haoyang Yan
assistant professor
University of Alabama at Birmingham