About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
TTM-Based Metaverse Lifestyle Health Education
BehavioralA 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, health behavior challenges, and peer support communities (20-30 minutes daily). It is supplemented by daily check-in prompts via WeChat groups and real-time clinical consultation from the research team. This intervention is designed to facilitate the adoption of health-promoting behaviors and enhance health-related quality of life among participants.
Treatment groups
Trial outcomes
Primary outcomes
Change in Health-Related Quality of Life Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Scale
The FACT-C scale, a colorectal cancer-specific validated instrument, comprises 36 items across 5 domains (physical, social/family, emotional, functional well-being, and colorectal cancer-specific subscale). Scores are standardized to a 0-100 range, with higher scores indicating better quality of life. The outcome measures the change in standardized scores from baseline to 1 mouth and 3 months post-intervention.
Improvement in Health-Promoting Behaviors Assessed by the Health-Promoting Lifestyle Profile II (HPLP II) Scale
The HPLP II scale includes 52 items across 6 domains (self-actualization, health responsibility, physical activity, nutrition, interpersonal support, stress management). Scores range from 52 to 208, with higher scores reflecting more consistent health-promoting behaviors. The outcome measures the change in total scores from baseline to 1 month and 3 months post-intervention.
Secondary outcomes
Change in Self-Efficacy Assessed by the Strategies Used by People to Promote Health (SUPPH) Scale
The SUPPH scale is a validated instrument for cancer patients, consisting of 28 items across 3 domains (positive attitude, self-stress reduction, self-decision-making). Scores range from 28 to 140, with higher scores indicating stronger self-efficacy. The outcome measures the change in total scores at 1-month and 3-month post-intervention compared with baseline.
Progression of Health Behavior Change Stages Assessed by the Transtheoretical Model (TTM) Stage Scale
The TTM Stage Scale classifies behavior change into 5 stages (pre-contemplation, contemplation, preparation, action, maintenance). The outcome evaluates the progression of participants' stages (defined as advancing at least one stage) at 1-month and 3-month post-intervention relative to baseline.
Change in BMI
Key physiological indicators include body mass index (BMI). The investigators collect BMI data via hospital laboratory tests to assess metabolic and tumor-related health status changes.
Change in CEA
Carcinoembryonic antigen (CEA) is a key physiological indicator. The investigators collect the data via hospital laboratory tests.
Locations
Sponsors and contacts
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Qu Shen
Lead sponsor
Xiamen University
Sponsor institution
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