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

NCT ID: NCT07234682

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-08-31

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.

Conditions

Colorectal Cancer (MSI-H); Anxiety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

standard-of-care chemotherapy

Intervention Type: 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.

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).

standard-of-care chemotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Provincial Hospital of Traditional Chinese Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xujin Guo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

HBZY2023-KY-050-01

Identifier Type: -

Identifier Source: org_study_id