Anxiety, Colorectal Cancer (MSI-H)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Hebei Provincial Hospital of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years; 2. Pathologically confirmed colorectal cancer (Stage II-IV); 3. Scheduled to receive a standard chemotherapy regimen (e.g., FOLFOX, FOLFIRI); 4. Able to understand and complete questionnaires.
Exclusion criteria
1. Severe cognitive impairment or psychiatric disorders other than anxiety/depression; 2. Concurrent use of psychotropic medications or sleep aids that could interfere with the study's primary measures; 3. Acute infection or autoimmune disease; 4. History of another primary malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD4+ T-cell Count | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4+/CD8+ Ratio | Baseline | 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. |
| Natural Killer (NK) Cell Count | Baseline | Absolute count of Natural Killer (NK) cells in peripheral blood, measured by flow cytometry and expressed as cells/μL. |
| EORTC QLQ-C30 Functional Scales Scores | Baseline | 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. |
| CD3+ T-cell Count | Baseline | Absolute count of total T-cells (CD3+) in peripheral blood, measured by flow cytometry and expressed as cells/μL. |
| Anxiety Severity Score | Baseline | 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. |
| Sleep Disturbance Severity Score | Baseline | 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. |
| EORTC QLQ-C30 Symptom Scales Scores | Baseline | 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. |
| CD8+ T-cell Count | Baseline | Absolute count of cytotoxic T-cells (CD8+) in peripheral blood, measured by flow cytometry and expressed as cells/μL. |
Countries
China
Outcome results
None listed