A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Colonoscopy completion rate
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the effectiveness of patient navigation on colonoscopy completion rates in a population screened for colorectal cancer. The main question[s] it aims to answer are:
Are colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants?
Is mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm?
Participants in the intervention arm will receive:
- standard clinic instructions for the colonoscopy
- phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure
- a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital
- a direct line for phone calls to patient navigators for further guidance on overcoming barriers
Participants in the control arm will only receive:
- standard clinic instructions for the colonoscopy
- one phone call from the patient navigator to discuss the colonoscopy procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Average risk for CRC
- •More than 50 years of age
- •Capacity for informed consent
- •IFOBT positive
排除标准
- •Moderate or high risk CRC
- •Previous CRC screening
- •Symptomatic
结局指标
主要结局
Colonoscopy completion rate
时间窗: 90 days
The numerator in both arms comprises participants who successfully attended and underwent colonoscopy within 90 days of recruitment. The denominator in both arms comprises all participants randomized to that arm. Colonoscopy completion rate was defined as the percentage of participants who completed colonoscopy within 90 days of randomization.
次要结局
- Mental health - anxiety and depression(90 days)
- Mental health - General psychological distress(90 days)