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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptom Cluster Group (n=45) | Patients with both clinically significant anxiety, defined as a Hospital Anxiety and Depression Scale - Anxiety (HADS-A) score of 8 or higher, AND significant sleep disturbance, defined as a Pittsburgh Sleep Quality Index (PSQI) global score greater than 5. |
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| No/Low Symptoms Group (n=58) | Patients who do not meet the criteria for the Symptom Cluster group (i.e., do not have both clinically significant anxiety and significant sleep disturbance). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard-of-care chemotherapy | Other | This is an observational study where participants are categorized based on pre-existing symptoms (exposure), not assigned to an intervention by the investigator. Therefore, no formal "intervention" is being tested. The "Interventions" section as shown in the screenshot should be left blank. All participants received their standard-of-care chemotherapy as prescribed by their oncologist, which is the context of the study, not the intervention being evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ T-cell Count | 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. | Baseline |
| Global Health Status / Quality of Life Score | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| CD3+ T-cell Count | Absolute count of total T-cells (CD3+) in peripheral blood, measured by flow cytometry and expressed as cells/μL. | Baseline |
| CD8+ T-cell Count | Absolute count of cytotoxic T-cells (CD8+) in peripheral blood, measured by flow cytometry and expressed as cells/μL. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a confirmed diagnosis of stage II-IV colorectal cancer undergoing a standard chemotherapy regimen (e.g., FOLFOX, FOLFIRI) at the Hebei Provincial Hospital of Traditional Chinese Medicine.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Hospital of Traditional Chinese Medicine | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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A 5 mL peripheral blood sample was collected in an EDTA-containing tube for determination of absolute counts of T-lymphocyte subsets (CD3+, CD4+, CD8+) and natural killer (NK) cells.
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| Baseline |
| CD4+/CD8+ Ratio | The ratio of CD4+ T-cell count to CD8+ T-cell count, calculated from flow cytometry data. This ratio is an important marker of immune health. | Baseline |
| Natural Killer (NK) Cell Count | Absolute count of Natural Killer (NK) cells in peripheral blood, measured by flow cytometry and expressed as cells/μL. | Baseline |
| EORTC QLQ-C30 Functional Scales Scores | Scores from the five functional scales of the EORTC QLQ-C30: Physical, Role, Emotional, Cognitive, and Social Functioning. Scores range from 0 to 100, with higher scores indicating better functioning. | Baseline |
| EORTC QLQ-C30 Symptom Scales Scores | Scores from the symptom scales of the EORTC QLQ-C30, including Fatigue, Pain, and Insomnia. Scores range from 0 to 100, with higher scores indicating a greater symptom burden. | Baseline |
| Anxiety Severity Score | Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The scale consists of 7 items, with a total score ranging from 0 to 21. A score of ≥8 indicates clinically significant anxiety. | Baseline |
| Sleep Disturbance Severity Score | Assessed using the global score of the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21. A score >5 indicates significant sleep disturbance. | Baseline |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001523 | Mental Disorders |