A Community-Based Cluster Randomized Trial Evaluating a Colorectal Cancer Screening Program Integrated Within the Rural Primary Healthcare System in China
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.
• Between 45 and 70 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).