Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study

March 19, 2024 updated by: Qu Shen

Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors - a Pilot Study

A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing adjuvant therapy after curative surgery for colorectal cancer.;
  • Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
  • PG-SGA (Patient-Generated Subjective Global Assessment) score less than 4.
  • be able to walk without assistance;
  • Conscious and intellectually normal;
  • Voluntarily participate in the research of this topic and provide the consent form for medical record review;
  • Mobile phones can be used.

Exclusion Criteria:

  • Patients with multiple cancers.
  • Tumors not completely resected.
  • Patients with severe psychological disorders, severe visual or hearing impairments, or other conditions that hinder intervention.
  • Patients with severe complications such as short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis, previous stroke, congestive heart failure or edema, liver or kidney failure, or other conditions that affect patient compliance.
  • In addition to colorectal cancer or any other diseases deemed unsuitable for participation by the researchers, patients with severe heart, liver, lung, or kidney diseases.
  • Patients with special dietary requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidimensional rehabilitation group
The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the patient's ability, opportunities, and motivation will be increased, thereby promoting healthy behavior.
Behavioral: multidimensional rehabilitation
Multidimensional lifestyle interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 4th week
Record the occurrence of adverse events, including nausea, vomiting, pain, etc.
4th week
Adherence
Time Frame: 4th week
The number of days per week that participants complied with the protocol will be recorded over a 4-week period.
4th week
Viability
Time Frame: 4th week
Record the number and reasons for loss to follow-up
4th week
Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: Change from Baseline at 4 weeks
This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
Change from Baseline at 4 weeks
Fear of Progression Questionaire-Short Form (FoP-Q-SF)
Time Frame: Change from Baseline at 4 weeks
The FoP-Q-SF was developed by German scholar Herschbach in 2005 in people such as diabetes, rheumatic diseases and cancer, to measure patients' fear of disease progression or recurrence, a total of 7 dimensions, 43 entries, Cronbach's α is 0.7. It is a single-dimensional scale with a total of 12 items, using the Liket 5-level scoring method, the score range is 12~60, the higher the score, the higher the level of fear.
Change from Baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lifestyle
Time Frame: Change from Baseline at 4 weeks
Assessments of lifestyle behaviors will be conducted using a self-developed behavior scale, focusing on the frequency of behaviors such as diet and smoking.
Change from Baseline at 4 weeks
The International Physical Activity Questionnaire (IPAQ)
Time Frame: Change from Baseline at 4 weeks
The International Physical Activity Questionnaire (IPAQ) is a commonly used tool for assessing individuals' levels of physical activity in their daily lives. It aims to measure individuals' physical activity over the past 7 days, including overall physical activity levels and the frequency of activities.
Change from Baseline at 4 weeks
30-second Chair Sit-To-Stand (30-s STS)
Time Frame: Change from Baseline at 4 weeks
Ability to test mobility and posture transposition. Using a chair without armrests, the number of times the participant could change from a sitting state (leaning back on the chair with both feet on the ground) to fully standing within 30 s was counted. Two tests were performed, with 1 min of rest in between, and the average value was rounded to the nearest value.
Change from Baseline at 4 weeks
BMI
Time Frame: Change from Baseline at 4 weeks
BMI reflects the patient's nutritional status and physical fitness.
Change from Baseline at 4 weeks
Semi-structured interviews
Time Frame: 4th week
After the intervention, semi-structured interviews were conducted with the participants. The main topics covered included the benefits and adverse reactions of the multidimensional rehabilitation intervention, factors that facilitated or hindered participation in the multidimensional rehabilitation, and the pros and cons of the metaverse platform.
4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qu Shen

Collaborators

The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XiamenUSQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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