Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
研究概览
简要总结
Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.
A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.
详细描述
Primary Outcome Measure:
Number of patients who receive a letter and patient navigation services and get screened compared to the control group.
Secondary Outcome Measures:
Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.
Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.
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
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Average risk men and women aged 50 - 74
- •Unscreened - Defined as no prior CRC screening
- •Under-screened - Defined as no FOBT screening within the last two years
- •No colonoscopy or barium enema screening within the last five years
- •Willing to provide consent to participate in the study.
排除标准
- •FOBT within the last two years
- •colonoscopy within five years
- •barium enema within five years
- •flexible sigmoidoscopy within five years
- •Bowel cancer.
结局指标
主要结局
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
时间窗: 48 weeks after baseline assessment
Completion of verified CRC screening events in experimental vs. control patients
次要结局
- Screening preferences; predictors of CRC screening and screening preference.(48 weeks)
研究者
Paul Ritvo, Ph.D.
Scientist, Research, Prevention and Cancer Control
Cancer Care Ontario