Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

NCT05956990 | Not Yet Recruiting

• 1 other identifier: XiamenUYHu
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Cancer Survivor; Rehabilitation; Quality of Life

Keywords

colorectal cancer survivor; Rehabilitation; Quality of Life; Fear of cancer recurrence; lifestyle; home-based

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Lifestyle

  Change from Baseline at 4 weeks

• The International Physical Activity Questionnaire (IPAQ)

  Change from Baseline at 4 weeks

• 30-second Chair Sit-To-Stand (30-s STS)

  Change from Baseline at 4 weeks

• BMI

  Change from Baseline at 4 weeks

• Chemotherapy completion rate

  4th week

Study Arms (2)

multidimensional rehabilitation group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

multidimensional rehabilitation BEHAVIORAL

Multidimensional lifestyle interventions

multidimensional rehabilitation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qu Shen: lead
• The First Affiliated Hospital of Xiamen University: collaborator

Related Publications (1)

• Hu Y, Peng H, Su G, Chen B, Yang Z, Ye Y, Zhou B, Lin S, Deng H, Zhang J, Xie Y, He H, Ruan Z, Shen Q. Effect of a metaverse multimodal rehabilitation intervention on quality of life and fear of recurrence in patients with colorectal cancer survivors: A randomized controlled study protocol. Digit Health. 2024 Nov 18;10:20552076241295542. doi: 10.1177/20552076241295542. eCollection 2024 Jan-Dec.

  PMID: 39564355 DERIVED

Central Study Contacts

Qu Shen

CONTACT

+865922189613; shenqumail@163.com

Study Design

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

Model Details: patients were randomly assigned to the rehabilitation group and control group by online randomization software

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 24, 2023
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share