Impact of Anxiety-Sleep Symptom Cluster on Immune Function and Quality of Life in Colorectal Cancer

Hebei Provincial Hospital of Traditional Chinese Medicine

Status: Completed

Conditions: Colorectal Cancer (MSI-H); Anxiety

Treatments: Other: standard-of-care chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT07234682

HBZY2023-KY-050-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

103 participants in 2 patient groups

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.

Treatment:

Other: standard-of-care chemotherapy

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).

Treatment:

Other: standard-of-care chemotherapy