Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT07180303
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colorectal Cancer Screening in Chinese Rural Communities
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
Study Overview
Official Title:
A Community-Based Cluster Randomized Trial Evaluating a Colorectal Cancer Screening Program Integrated Within the Rural Primary Healthcare System in China
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRC-RPHC
Brief Summary:
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.
Detailed Description:
\*\*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 40 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.
\*\*4. Data Collection and Analysis\*\*
* \*\*Primary Outcome Measures:\*\*
* Phase I: Improvement in colonoscopy adherence.
* Phase II: Trends in colorectal cancer incidence.
* Phase III: Long-term impact on colorectal cancer mortality.
* \*\*Secondary Outcome Measures:\*\* Participants' understanding of CRC prevention and control, changes in lifestyle behaviors, etc.
* \*\*Data Analysis:\*\* Appropriate statistical software will be used to analyze the data, comparing differences between the two groups while accounting for potential confounding factors.
\*\*5. Potential Supplementary Aspects\*\*
* \*\*Community Education:\*\* Strengthen health education activities at the community level to enhance public awareness of colorectal cancer and self-protection.
* \*\*Cost-Effectiveness Analysis:\*\* Conduct a cost-effectiveness analysis to evaluate the economic benefits of the intervention.
* \*\*Ethical Considerations:\*\* Ensure all participants are fully informed about the study's purpose and provide consent, while safeguarding individual privacy.
\*\*6. Feasibility Assessment\*\*
* \*\*Resource Availability:\*\* Confirm sufficient funding to support project operations, including development of training materials and maintenance of the technological platform.
* \*\*Technical Readiness:\*\* Ensure the technical requirements for remote training are met, such as stable internet connectivity and a user-friendly learning management system.
* \*\*Personnel Training:\*\* Ensure participating healthcare providers possess the necessary foundational knowledge and can effectively apply the acquired knowledge in clinical practice.
\*\*2. Study Design\*\*
* \*\*Target Population:\*\* Fifteen natural villages within a county or city will be selected as study sites, encompassing permanent residents aged between 40 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.
\*\*4. Data Collection and Analysis\*\*
* \*\*Primary Outcome Measures:\*\*
* Phase I: Improvement in colonoscopy adherence.
* Phase II: Trends in colorectal cancer incidence.
* Phase III: Long-term impact on colorectal cancer mortality.
* \*\*Secondary Outcome Measures:\*\* Participants' understanding of CRC prevention and control, changes in lifestyle behaviors, etc.
* \*\*Data Analysis:\*\* Appropriate statistical software will be used to analyze the data, comparing differences between the two groups while accounting for potential confounding factors.
\*\*5. Potential Supplementary Aspects\*\*
* \*\*Community Education:\*\* Strengthen health education activities at the community level to enhance public awareness of colorectal cancer and self-protection.
* \*\*Cost-Effectiveness Analysis:\*\* Conduct a cost-effectiveness analysis to evaluate the economic benefits of the intervention.
* \*\*Ethical Considerations:\*\* Ensure all participants are fully informed about the study's purpose and provide consent, while safeguarding individual privacy.
\*\*6. Feasibility Assessment\*\*
* \*\*Resource Availability:\*\* Confirm sufficient funding to support project operations, including development of training materials and maintenance of the technological platform.
* \*\*Technical Readiness:\*\* Ensure the technical requirements for remote training are met, such as stable internet connectivity and a user-friendly learning management system.
* \*\*Personnel Training:\*\* Ensure participating healthcare providers possess the necessary foundational knowledge and can effectively apply the acquired knowledge in clinical practice.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: