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Trial Title:
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors
NCT ID:
NCT05956990
Condition:
Colorectal Cancer Survivor
Rehabilitation
Quality of Life
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer survivor
Rehabilitation
Quality of Life
Fear of cancer recurrence
lifestyle
home-based
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
patients were randomly assigned to the rehabilitation group and control group by online
randomization software
Primary purpose:
Supportive Care
Masking:
Double (Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
multidimensional rehabilitation
Description:
Multidimensional lifestyle interventions
Arm group label:
multidimensional rehabilitation group
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Qu Shen
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05956990
