NCT07234682

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Hebei Provincial Hospital of Traditional Chinese Medicine · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer (MSI-H)
• Anxiety

Interventions

Type	Name	Description
OTHER	standard-of-care chemotherapy	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China