1. Study Background Colorectal cancer ranks 2nd in incidence and 4th in mortality among malignant tumors in China, with 517,000 new cases and 240,000 deaths in 2022, and the number of patients is expected to increase to 910,000 by 2040. Surgical and other treatment methods have prolonged patients' survival, transforming the disease into a chronic condition requiring long-term management. However, postoperative patients generally experience physical symptoms such as pain and gastrointestinal disorders, as well as psychological problems such as fear of recurrence and anxiety, and have low compliance with healthy lifestyle behaviors such as balanced diet and regular exercise. Traditional health education mainly relies on paper manuals and verbal guidance, lacking phased behavioral interventions and continuous interactive support, which cannot effectively promote the development of long-term healthy behaviors in patients.
The Transtheoretical Model (TTM) divides behavior change into 5 stages (pre-contemplation, contemplation, preparation, action, maintenance) and can provide targeted behavioral intervention strategies; metaverse technology has the advantages of immersion and high interactivity, which can break the temporal and spatial limitations of traditional education. This study integrates TTM theory, lifestyle medicine (including six pillars such as diet, exercise, and stress management) and metaverse technology to build a new health education model, aiming to address the core pain points of health management for colorectal cancer survivors.
2. Study Design
This is a prospective multicenter randomized controlled trial conducted in 3 Grade A tertiary hospitals: The First Affiliated Hospital of Xiamen University, Zhongshan Hospital Affiliated to Xiamen University, and Xiang'an Hospital Affiliated to Xiamen University. The study is divided into 3 phases:
2.1 Theoretical Construction Phase: Develop phased lifestyle health education courses based on TTM through literature research and expert consultation, and complete the functional adaptation of the metaverse platform (including modules such as graphic and text education, course learning, health challenges, and patient communities); 2.2 Intervention Implementation Phase: After signing the informed consent form, eligible patients are randomly grouped by tumor stage and age through the central randomization system (REDCap platform). The experimental group receives 3-month metaverse intervention (3 days for pre-contemplation stage, 4 days for contemplation stage, 7 days for preparation stage, 14 days for action stage, 14 days for maintenance stage, with a daily intervention duration of 20-30 minutes), and completes daily check-ins and medical Q\&A through WeChat groups; the control group receives routine health education (distribute the Postoperative Rehabilitation Manual for Colorectal Cancer and complete postoperative follow-up according to hospital procedures); 2.3 Effect Evaluation Phase: Collect patients' quality of life (FACT-C scale), healthy lifestyle (HPLP II scale), self-efficacy (SUPPH scale), and physiological indicators such as BMI and CEA before intervention (T0), 1 month after intervention (T1), and 3 months after intervention (T2). Meanwhile, record the usage compliance of the metaverse platform and adverse events.
3. Study Endpoints 3.1 Primary Endpoints: Changes in standardized scores of the FACT-C scale and scores of the HPLP II scale in patients at 3 months after intervention (T2) compared with baseline (T0); 3.2 Secondary Endpoints: Changes in SUPPH scale scores, progress of behavior change stages, improvement of physiological indicators, platform usage compliance and satisfaction of patients during T0-T2; 3.3 Safety Endpoints: Incidence and severity of adverse events (such as exercise-related muscle soreness and platform operation discomfort) during the intervention period.
4. Quality Control The research team will conduct a unified baseline assessment of enrolled patients, and intervention personnel will take up their posts after passing GCP and platform operation training and assessment; double independent data entry is adopted, and missing values are handled by multiple imputation; meanwhile, a monitoring group is established to verify data from each center every 2 months to ensure the accuracy and completeness of research data.
