Nurse-led Colon Cancer Risk Counseling for First-degree Relatives to Enhance Use of Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 66
- 主要终点
- utilization of preventive colonoscopy
研究概览
简要总结
BACKGROUND: First-degree relatives of patients with colorectal cancer are at increased risk for colorectal cancer as well. Nevertheless, participation in the German national screening program stagnates at 2-3 percent per year even in this high-risk population.
AIM: The study is aimed to increase the portion of the first-degree relatives on 50% which take up a preventive colonoscopy.
METHODS: Cluster-randomized controlled multi-center trial. Study sites (clusters) are mainly certified cancer centers and office-based gastroenterologists from all over Germany. Index-patients with colorectal cancer of different stages are asked to hand over the study material to their relatives, consisting of an invitation to a nurse-led counseling on preventive colonoscopy and an one-to-one appointment with a clinical expert of one of the study sites next.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 and over
- •being first-degree relatives of patients with diagnosed colorectal cancer
- •able to understand German
排除标准
- •Familial Adenomatous Polyposis
- •utilization of diagnostic colonoscopy within the past 5 years
- •being ever treated for colorectal cancer
- •actual inflammatory bowl disease
- •comorbidities associated with reduced further life expectancy (ECOG performance status >3
结局指标
主要结局
utilization of preventive colonoscopy
时间窗: utilization within 30 days after enrolement
次要结局
- Rate of advanced adenomas or carcinomas in situ(Rate within 6 month after enrolement)
- post-operative complications associated with the colonoscopy(within 30 days after enrolement)
- barriers to the use of preventive colonoscopy(within 30 day after enrolement, additional at 6 months after enrolement)
- effectiveness and cost-effectiveness of nurse-led counselling(within 30 days after enrolement)
- time delay between signed informed consent and utilization of colonoscopy(at utilization of the colonoscopy)
研究者
Alexander Bauer
PhD
Martin-Luther-Universität Halle-Wittenberg