A Community-Based Cluster Randomized Trial Evaluating a Colorectal Cancer Screening Program Integrated Within the Rural Primary Healthcare System in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20,026
- 试验地点
- 1
- 主要终点
- Improvement in colonoscopy adherence
研究概览
简要总结
Colorectal cancer (CRC) is one of the most common malignant neoplasms significantly impacting population health and longevity. With the transformation of lifestyle and dietary patterns among Chinese residents, coupled with an increasingly aging population, both the incidence and mortality rates of CRC in China have exhibited a sustained upward trend. CRC often presents with insidious onset; the five-year survival rate for patients diagnosed at intermediate or advanced stages remains below 15%. In contrast, early diagnosis and treatment can achieve a five-year survival rate exceeding 90%. Furthermore, population-based CRC screening in mainland China is still in its nascent stages. Although preliminary, small-to-medium-scale screening programs have been implemented in certain regions, participation rates in risk assessment questionnaires and fecal occult blood testing remain suboptimal, attributable to regional disparities and variations in cultural and educational backgrounds. Moreover, adherence to the pivotal diagnostic procedure-colonoscopy-within screening programs is notably low, estimated at approximately 20% to 30%. Consequently, more refined and scientifically grounded mobilization and educational campaigns are critically important to enhance participation in population-based CRC screening initiatives.
详细描述
**1. Background and Objectives** This study aims to investigate, through a cluster randomized controlled trial (RCT), whether remote training for primary care physicians can effectively enhance the accessibility and adherence to colorectal cancer (CRC) screening. Specifically, the intervention group will receive professional training on CRC screening guidelines, standards of care for high-risk individuals, and dietary interventions, while the control group will receive no additional training. The ultimate goal is to improve community residents' awareness of colorectal cancer, increase screening participation, and reduce both incidence and mortality rates.
**2. Study Design**
- **Target Population:** Fifteen natural villages within a county or city will be selected as study sites, encompassing permanent residents aged between 45 and 74 years.
- **Randomization:** A cluster randomization method will be employed to randomly assign the 15 villages to either Group A (intervention group) or Group B (control group). Each group will include at least seven villages to ensure adequate sample size.
- **Sample Size Calculation:** The required sample size will be determined based on estimated changes in screening adherence rates and other relevant parameters.
**3. Intervention**
- **Intervention Group (Group A):**
- Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies.
- Ongoing support services, such as regular knowledge updates and technical consultations.
- **Control Group (Group B):**
- Continuation of routine healthcare services without any additional training interventions.
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
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 45 and 74 years old (inclusive).
- •Permanent resident within the geographic area covered by the screening program (typically defined as residing in the area for a minimum period, e.g., 6 months or more), and possessing local household registration (hukou) or residency documentation.
- •Self-reported absence of symptoms suggestive of colorectal cancer (e.g., rectal bleeding, change in bowel habits, abdominal pain, palpable abdominal mass, unexplained anemia, or unintentional weight loss).
- •No prior diagnosis of colorectal cancer or precancerous lesions (e.g., high-grade intraepithelial neoplasia, serrated lesions with dysplasia).
- •Not currently participating in another colorectal cancer-related clinical study that might interfere with the screening outcomes.
- •Willing and able to provide written informed consent, agreeing to participate in the screening program and comply with subsequent follow-up procedures (e.g., fecal testing, colonoscopy).
排除标准
- •Previous diagnosis of colorectal cancer, history of resection of colorectal polyps (especially high-grade lesions or serrated lesions with dysplasia), or diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
- •Completion of a high-quality colonoscopy within a specified timeframe (e.g., within the past 1 year) with normal results (no polyps or only 1-2 tubular adenomas <10mm), or completion of a high-quality sigmoidoscopy within a specified timeframe (e.g., within the past 3 years) with normal results.
- •Presence of severe comorbid conditions (e.g., severe cardiac, pulmonary, hepatic, or renal insufficiency) resulting in a life expectancy of less than 10 years, or physical condition unable to tolerate colonoscopy and bowel preparation.
- •Conditions such as severe coagulopathy, recent acute myocardial infarction or stroke (e.g., within the past 3 months), or severe psychiatric illness preventing cooperation.
- •Generally excluded due to safety considerations regarding screening colonoscopy during these periods.
- •Inability to understand the study content and provide informed consent due to cognitive impairment, language barriers, or other reasons.
- •Judged by the investigator to have a very high likelihood of being lost to follow-up during the study period, making completion of the screening pathway unlikely.
研究组 & 干预措施
Integrated CRC Screening Program
- Provide remote training courses covering the latest colorectal cancer screening guidelines, methods for identifying high-risk individuals and their standards of care, as well as dietary intervention strategies.
- Offer ongoing support services, such as regular knowledge updates and technical consultations.
干预措施: Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services, (Other)
Standard Care / Usual Practice
Current opportunistic screening practices within the rural primary healthcare system.
干预措施: Continuation of routine healthcare services without any additional training interventions. (Other)
结局指标
主要结局
Improvement in colonoscopy adherence
时间窗: 1 year
Proportion of patients undergoing colonoscopy, The proportion of patients who, after questionnaire screening and fecal occult blood testing, are indicated for colonoscopy and ultimately undergo the procedure.
次要结局
- Trends in colorectal cancer incidence(1 year)
- Long-term impact on colorectal cancer mortality(5 year)