Clinical trial NCT05957289: Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study
Official title: Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors - a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Colorectal Cancer Survivor
Quality of Life
Pilot Study
Keywords: Colorectal cancer survivor
Rehabilitation
Quality of Life
Fear of cancer recurrence
Lifestyle
Home-based
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Xiamen University
First posted: 2023-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of adverse events
timeFrame: 4th week
measure: Adherence
timeFrame: 4th week
measure: Viability
timeFrame: 4th week
measure: Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
timeFrame: Change from Baseline at 4 weeks
measure: Fear of Progression Questionaire-Short Form (FoP-Q-SF)
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
measure: Lifestyle
timeFrame: Change from Baseline at 4 weeks
measure: The International Physical Activity Questionnaire (IPAQ)
timeFrame: Change from Baseline at 4 weeks
measure: 30-second Chair Sit-To-Stand (30-s STS)
timeFrame: Change from Baseline at 4 weeks
measure: BMI
timeFrame: Change from Baseline at 4 weeks
measure: Semi-structured interviews
timeFrame: 4th week
Other outcomes:
Locations:
Study officials:
References: