Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

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

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: Quality of Life; Rehabilitation; Colorectal Cancer Survivor
• Intervention / Treatment: Behavioral: multidimensional rehabilitation

Detailed Description

After a patient is diagnosed with colorectal cancer, the tumour is completely controlled after a short period of treatment in hospital, and the patient returns to his or her family as a cancer survivor and begins a long period of recovery. However, due to the stress of surgery, the side effects of radiotherapy, chemotherapy and lifestyle changes, the quality of life of colorectal cancer survivors is often lower. Studies have shown that regular rehabilitation during or after cancer treatment can prolong survival, improve cardiorespiratory fitness, body composition and physical function, reduce fatigue, relieve anxiety and depression, and improve quality of life. However, there is a lack of comprehensive and systematic rehabilitation support for colorectal cancer survivors.

The main aim of our study is to establish a community multidimensional rehabilitation programme, to investigate its impact on improving outcome indicators such as quality of life, fear of recurrence and functional ability in colorectal cancer patients, to assess the feasibility and safety of this programme, and ultimately to establish a scalable community multidimensional rehabilitation programme for colorectal cancer.

We will conduct a randomised controlled trial at the First Affiliated Hospital of Xiamen University using a combination of online and offline recruitment. A total of 104 colorectal cancer survivors will be recruited. After obtaining informed consent from the survivors, the subjects will be numbered according to the order of inclusion, and simple random sampling will be performed using SPSS random number table method.

Patient inclusion criteria are: ① Completion of initial treatment for colon or rectal cancer (stage 1-3); Age 18 years or older, expected survival ≥6 months; Ability to walk without assistance; ④ No major surgery within the last 1 month; ⑤ Clear consciousness and normal intelligence; ⑥ Voluntary participation in this research and consent to medical record review; ⑦ Ability to use mobile phones. Inclusion criteria for patients: ⑧ Patients complained of functional impairment such as fatigue, anxiety, depression, loss of muscle strength, etc.

Patient exclusion criteria ① Those who did not know their own condition due to family members' request to conceal their condition; ② Patients with advanced colorectal cancer with distant metastasis, recurrence or multiple organ failure. Patients with multiple cancers. (4) Patients with severe psychological disorders, strict attention, hearing disorders and other influences of the intervention.

Exit criteria: ① Death during the study. ② Leaving the study for their own reasons.

After recruitment, written informed consent and oncologist's medical approval were obtained and baseline assessment was completed. The duration of the intervention was 6 weeks, with 3 weeks being 1 cycle.

The experimental group will explore multidimensional rehabilitation in the community. The intervention is based on the behaviour change wheel theory, and multidimensional rehabilitation intervention was implemented on the basis of family, including diet intervention, exercise intervention, psychological support, behaviour management and family support. Through training, education, motivation and other ways to increase patients' ability, opportunity and motivation, so as to increase the subjects' health behaviour and improve their quality of life. The control group receives routine care.

Quality of life, fear of relapse, healthy lifestyle, 30-second chair-stand test and BMI will be measured at baseline, week 3 and week 6. Patient persistence and discontinuation will be recorded throughout.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qu SHEN; Phone Number: +865922189613; Email: shenqumail@163.com

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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
No Intervention: Control group; The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	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)	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	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)	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)	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	BMI reflects the patient's nutritional status and physical fitness.	Change from Baseline at 4 weeks
Chemotherapy completion rate	Chemotherapy completion rate	4th week
White blood cell count	White blood cell count	Change from Baseline at 4 weeks
Red blood cell count	Red blood cell count	Change from Baseline at 4 weeks
Hemoglobin concentration	Hemoglobin concentration	Change from Baseline at 4 weeks
Platelet count	Platelet count	Change from Baseline at 4 weeks

Collaborators and Investigators

• Sponsor: Qu Shen
• Collaborators: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 4, 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: Rehabilitation; Quality of Life; lifestyle; home-based; Fear of cancer recurrence; colorectal cancer survivor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: XiamenUYHu

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