Clinical trial · Observational
Impact of Anxiety-Sleep Symptom Cluster on Immune Function and Quality of Life in Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Colorectal Cancer (MSI-H) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard-of-care chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Symptom Cluster Group (n=45)
- description
- 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.
- interventionNames
- Other: standard-of-care chemotherapy
- label
- No/Low Symptoms Group (n=58)
- description
- 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).
- interventionNames
- Other: standard-of-care chemotherapy
Primary outcomes (2)
- measure
- CD4+ T-cell Count
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available