The Impact of the Anxiety-Sleep Disturbance Symptom Cluster on Cellular Immune Function and Quality of Life in Colorectal Cancer Patients During Chemotherapy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- CD4+ T-cell Count
研究概览
简要总结
This prospective observational study investigates the impact of the anxiety-sleep disturbance symptom cluster on cellular immune function and quality of life in colorectal cancer (CRC) patients undergoing chemotherapy. The study aims to determine if patients with clinically significant anxiety and sleep disturbance exhibit poorer immune cell profiles (e.g., T-cells, NK cells) and lower quality of life compared to patients with no or low symptoms.
详细描述
Colorectal cancer (CRC) patients often experience debilitating symptom clusters during chemotherapy. The co-occurrence of anxiety and sleep disturbance is particularly common and may have a synergistic negative effect on patients' physiological and psychological well-being. This study was designed based on the principles of psychoneuroimmunology (PNI), which suggest that psychological states can influence the immune system. A total of 103 patients with Stage II-IV CRC undergoing standard chemotherapy were enrolled. Participants were assessed at the beginning of a chemotherapy cycle using validated questionnaires: the Hospital Anxiety and Depression Scale (HADS) for anxiety, the Pittsburgh Sleep Quality Index (PSQI) for sleep disturbance, and the EORTC QLQ-C30 for quality of life. Peripheral blood samples were collected to quantify lymphocyte subsets (CD3+, CD4+, CD8+, NK cells) via flow cytometry. Patients were stratified into a "Symptom Cluster" group (HADS-A ≥ 8 and PSQI > 5) and a "No/Low Symptoms" group. The study compares immune parameters and quality of life scores between the two groups and uses correlation and regression analyses to explore the relationships between symptom severity, immune function, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Pathologically confirmed colorectal cancer (Stage II-IV);
- •Scheduled to receive a standard chemotherapy regimen (e.g., FOLFOX, FOLFIRI);
- •Able to understand and complete questionnaires.
排除标准
- •Severe cognitive impairment or psychiatric disorders other than anxiety/depression;
- •Concurrent use of psychotropic medications or sleep aids that could interfere with the study's primary measures;
- •Acute infection or autoimmune disease;
- •History of another primary malignancy.
结局指标
主要结局
CD4+ T-cell Count
时间窗: Baseline
Absolute count of helper T-cells (CD4+) in peripheral blood, measured by flow cytometry. Results are expressed as cells per microliter (cells/μL). A lower count indicates a more compromised immune status.
Global Health Status / Quality of Life Score
时间窗: Baseline
Assessed using the global health status/QoL scale from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores are transformed to a 0-100 scale, with a higher score indicating a better global quality of life.
次要结局
- CD3+ T-cell Count(Baseline)
- CD8+ T-cell Count(Baseline)
- CD4+/CD8+ Ratio(Baseline)
- Natural Killer (NK) Cell Count(Baseline)
- EORTC QLQ-C30 Functional Scales Scores(Baseline)
- EORTC QLQ-C30 Symptom Scales Scores(Baseline)
- Anxiety Severity Score(Baseline)
- Sleep Disturbance Severity Score(Baseline)
研究者
Xujin Guo
Principal investigator
Hebei Provincial Hospital of Traditional Chinese Medicine