A Study on the Efficacy of the Metaverse Lifestyle Health Education Model Based on the Transtheoretical Model for Improving Quality of Life and Modifying Lifestyle in Colorectal Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TTM-Based Metaverse Lifestyle Health Education.
- Who it may be relevant to
- Registry conditions: Colorectal Neoplasms, Cancer Survivors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Colorectal cancer is a globally prevalent malignant tumor. Postoperative patients often face physical discomfort, psychological stress, and lack of healthy lifestyles. However, traditional health education models have limitations such as insufficient targeting and poor interactivity, making it difficult to meet their needs for full-cycle health management. This study is a multicenter randomized controlled trial, which plans to enroll 174 patients aged 18 years and above who have undergone radical resection for colorectal cancer, and randomly divide them into an experimental group and a control group at a ratio of 1:1. The experimental group will receive Transtheoretical Model (TTM)-based metaverse lifestyle health education (including phased course learning, metaverse immersive interaction, and WeChat group check-in supervision) with an intervention cycle of 1 months and follow-up until 3 months after the intervention; the control group will only receive routine paper-based education and outpatient follow-up. The study aims to verify the improvement effect of this metaverse intervention model on the quality of life and healthy lifestyle of colorectal cancer survivors, and explore its role in improving patients' self-efficacy, so as to provide empirical evidence for optimizing long-term health management programs for cancer survivors.
Detailed description
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.
Interventions
- Behavioral TTM-Based Metaverse Lifestyle Health Education
A three-month, stage-stratified behavioral intervention targeting colorectal cancer postoperative survivors, developed in alignment with the five stages of the Transtheoretical Model (TTM): pre-contemplation, contemplation, preparation, action, and maintenance. The intervention encompasses lifestyle modification modules (encompassing dietary guidance, physical activity protocols, and stress management) delivered via a metaverse platform-including didactic materials, immersive interactive modules
Primary outcome measures
- Change in Health-Related Quality of Life Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Scale [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Improvement in Health-Promoting Behaviors Assessed by the Health-Promoting Lifestyle Profile II (HPLP II) Scale [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
Secondary outcome measures (8)
- Change in Self-Efficacy Assessed by the Strategies Used by People to Promote Health (SUPPH) Scale [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Progression of Health Behavior Change Stages Assessed by the Transtheoretical Model (TTM) Stage Scale [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Change in BMI [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Change in CEA [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Change in Blood Glucose [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Change in Blood Lipids [Time frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)]
- Intervention Adherence Rate of Metaverse Platform Usage [Time frame: Weekly during the 3-month intervention period; summarized at 3 months after intervention (T2)]
- Participant Satisfaction with the Metaverse Health Education Platform [Time frame: 1 month after intervention (T1), 3 months after intervention (T2)]
Eligibility criteria
Inclusion criteria
- Patients with first diagnosed colorectal cancer who have undergone radical surgical treatment
- Aged ≥18 years old and non-pregnant
- Have basic communication, reading and comprehension abilities, and can proficiently use smartphones and WeChat
- Voluntarily sign the informed consent form and promise to cooperate in completing all interventions and follow-up assessments
Exclusion criteria
- Patients with other types of malignant tumors
- Patients with incompletely resected tumors or distant metastases
- Patients with dysfunction of important organs such as heart, liver and kidney, or with unstable/rapidly deteriorating conditions
- Patients with severe cognitive impairment who cannot communicate normally and cooperate with the intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07362823 · XDYX202510K58