A Randomized Controlled Clinical Trial on the Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Degree of improvement in emotional distress
研究概览
简要总结
Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model.
During the intervention period, trained oncology advanced practice nurses conducted weekly questionnaire surveys for enrolled patients. During the follow-up period, these surveys were conducted every four weeks. Peripheral venous blood samples were collected at baseline and at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed with head and neck malignancy.
- •Experiencing psychological distress.
- •Aged between 18 and 70 years.
- •Patients scheduled to receive antitumor treatment in a day hospital or outpatient setting.
- •ECOG performance status score of 0-
- •Patients voluntarily participate, fully understand, and are able to independently complete the questionnaires.
排除标准
- •A history of other malignancies within the past 5 years.
- •A history of any mental illness, including but not limited to: generalized anxiety disorder, depressive disorder, panic disorder, schizophrenia, or bipolar disorder.
- •Patients currently receiving other psychological treatments or taking psychiatric medications.
研究组 & 干预措施
Conventional rehabilitation model
干预措施: Conventional rehabilitation model (Other)
Self-help rehabilitation model
干预措施: Self-help rehabilitation model (Other)
结局指标
主要结局
Degree of improvement in emotional distress
时间窗: 16 weeks
After the intervention period for the patients, the change in the HADS (Hospital Anxiety and Depression Scale) total score was assessed based on the scoring criteria, comparing the scores to the baseline. The HADS scoring ranges are as follows: Total Score Range: 0 to 42； Anxiety Subscale (HADS-A): 0 to 21； Depression Subscale (HADS-D): 0 to 21； Score Interpretation: 0-7: Normal range, typically indicating no significant anxiety or depression symptoms.； 8-10: Mild anxiety or depression, may warrant monitoring; 11-14: Moderate anxiety or depression, further assessment or intervention is advisable; 15 and above: Severe anxiety or depression, usually requiring professional mental health intervention; In summary, higher scores on the HADS indicate more severe symptoms of anxiety or depression.
次要结局
- Levels of improvement in quality of life(16 weeks)
- Levels of anxiety and depression(16 weeks)
- Levels of Supportive care needs(16 weeks)
研究者
Xingchen Peng
Professor
West China Hospital