Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Fear of Progression Questionaire-Short Form (FoP-Q-SF)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: multidimensional rehabilitation (Behavioral)
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.
结局指标
主要结局
Fear of Progression Questionaire-Short Form (FoP-Q-SF)
时间窗: Change from Baseline at 4 weeks
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.
Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
时间窗: Change from Baseline at 4 weeks
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.
次要结局
- Platelet count(Change from Baseline at 4 weeks)
- The International Physical Activity Questionnaire (IPAQ)(Change from Baseline at 4 weeks)
- White blood cell count(Change from Baseline at 4 weeks)
- Red blood cell count(Change from Baseline at 4 weeks)
- BMI(Change from Baseline at 4 weeks)
- Chemotherapy completion rate(4th week)
- Hemoglobin concentration(Change from Baseline at 4 weeks)
- Lifestyle(Change from Baseline at 4 weeks)
- 30-second Chair Sit-To-Stand (30-s STS)(Change from Baseline at 4 weeks)
研究者
Qu Shen
Associate Professor
Xiamen University