Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study

NCT ID: NCT05957289

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-30

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

Rehabilitation; Colorectal Cancer Survivor; Quality of Life; Pilot Study

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

multidimensional rehabilitation

Intervention Type: BEHAVIORAL

Multidimensional lifestyle interventions

Interventions

multidimensional rehabilitation

Multidimensional lifestyle interventions

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Qu Shen

OTHER

Sponsor Role: lead

Responsible Party

Qu Shen

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Qu Shen

Role: CONTACT

shenqumail@163.com

+865922189613

Other Identifiers

XiamenUSQ

Identifier Type: -

Identifier Source: org_study_id