NCT07362823

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

December 27, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

December 27, 2025

Last Update Submit

January 26, 2026

Conditions

Keywords

Colorectal NeoplasmsCancer SurvivorsTranstheoretical Model (TTM)MetaverseLifestyle InterventionHealth EducationQuality of LifeSelf-EfficacyHealth BehaviorMulticenter Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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.

    Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)

Secondary Outcomes (8)

  • Change in Self-Efficacy Assessed by the Strategies Used by People to Promote Health (SUPPH) Scale

    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

    Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)

  • Change in BMI

    Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)

  • Change in CEA

    Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)

  • Change in Blood Glucose

    Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)

  • +3 more secondary outcomes

Study Arms (2)

TTM-Based Metaverse Lifestyle Health Education Arm

EXPERIMENTAL

Administer TTM-phased lifestyle health education via metaverse platform (including health courses, immersive interactions, peer communities) and WeChat group check-in/medical Q\&A. Assess indicators at baseline, 1-month, 3-month post-intervention.

Behavioral: TTM-Based Metaverse Lifestyle Health Education

Routine Colorectal Cancer Postoperative Health Education Arm

NO INTERVENTION

Provide paper-based postoperative rehabilitation manual and verbal lifestyle guidance; conduct routine telephone/outpatient follow-up per hospital protocol. Assess indicators at the same time points as the intervention arm.

Interventions

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, 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.

Also known as: TTM-Metaverse Health Education
TTM-Based Metaverse Lifestyle Health Education Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsHealth EducationHealth Behavior

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 27, 2025

First Posted

January 23, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01