- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362823
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
- 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.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xinyu Huang
- Phone Number: 19509906220
- Email: 19509906220@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TTM-Based Metaverse Lifestyle Health Education Arm
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.
|
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.
Other Names:
|
|
No Intervention: Routine Colorectal Cancer Postoperative Health Education Arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
Time Frame: Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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.
|
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)
|
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.
|
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)
|
Adherence is defined as the percentage of actual completed intervention tasks (including daily metaverse platform usage and course learning) relative to the required tasks.
A rate ≥70% is classified as high adherence.
|
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)
|
Assessed by a validated self-designed questionnaire (5-point Likert scale) covering platform functionality, course content relevance, interactive experience, and perceived intervention benefits.
Higher scores indicate greater satisfaction.
|
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)
|
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.
|
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)
|
Carcinoembryonic antigen (CEA) is a key physiological indicator.
The investigators collect the data via hospital laboratory tests.
|
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)
|
The investigators collect the data of fasting blood glucose via hospital laboratory tests to assess metabolic and tumor-related health status changes.
|
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)
|
The investigators collect the data of total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) via hospital laboratory tests to assess metabolic and tumor-related health status changes.
|
Baseline (T0), 1 month after intervention (T1), 3 months after intervention (T2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Behavior
- Treatment Adherence and Compliance
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Colorectal Neoplasms
- Health Behavior
- Health Education
Other Study ID Numbers
- XDYX202510K58
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasms
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...CompletedColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
NuCana plcCompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States, France, United Kingdom
-
The Queen Elizabeth HospitalNovartis; AmgenCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalAustralia
-
Novartis PharmaceuticalsCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
ProgenaBiomeWithdrawnColorectal Neoplasms | Colorectal Cancer | Colorectal Cancer Metastatic | Colorectal Carcinoma | Colorectal Adenocarcinoma | Colorectal SarcomaUnited States
-
University of ChicagoVerastem, Inc.SuspendedColorectal Cancer | Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Advanced Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
Bristol-Myers SquibbNovartisCompletedColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaUnited States, Canada, Spain, Argentina, Australia, Belgium, Czechia, Italy, Chile, Germany
-
Pawel KalinskiNational Cancer Institute (NCI)CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Jeremy MeyerUniversity Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, SwitzerlandNot yet recruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Neoplasms, Benign
Clinical Trials on TTM-Based Metaverse Lifestyle Health Education
-
Suleyman Demirel UniversityNot yet recruitingNursing Education | Intramuscular Injection | Metaverse
-
Suleyman Demirel UniversityCompleted
-
Suleyman Demirel UniversityNot yet recruitingEducational Interventions | Palpation Skills | Physical Therapy Education | Health Professions Education
-
University of Alabama at BirminghamU.S. Department of EducationCompletedTraumatic Brain InjuryUnited States
-
Universiti Teknologi MaraRecruitingKnowledge, Attitudes, PracticeMalaysia
-
Sun Yat-sen UniversityNot yet recruitingSmoking Cessation | Behavioral Intervention
-
Healthy Minds InitiativeUniversity of California, Los Angeles; Stanford University; Charles Drew University... and other collaboratorsRecruiting
-
Saudi Commission for Health Specialties, Saudi...Unknown
-
Northwestern UniversityCompletedHypertension | Obesity | Diabetes | Hyperlipidemia | Pre-diabetesUnited States
-
University of FloridaNational Heart, Lung, and Blood Institute (NHLBI)Completed