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NCT Number: NCT07234682

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Pathologically confirmed colorectal cancer (Stage II-IV);
  • Scheduled to receive a standard chemotherapy regimen (e.g., FOLFOX, FOLFIRI);
  • Able to understand and complete questionnaires.

Exclusion criteria

  • Severe cognitive impairment or psychiatric disorders other than anxiety/depression;
  • Concurrent use of psychotropic medications or sleep aids that could interfere with the study's primary measures;
  • Acute infection or autoimmune disease;
  • History of another primary malignancy.

Treatment and study plan

standard-of-care chemotherapy

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.

Primary outcomes

  1. CD4+ T-cell Count

    Time frame: 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.

  2. Global Health Status / Quality of Life Score

    Time frame: 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 outcomes

  1. CD3+ T-cell Count

    Time frame: Baseline

    Absolute count of total T-cells (CD3+) in peripheral blood, measured by flow cytometry and expressed as cells/μL.

  2. CD8+ T-cell Count

    Time frame: Baseline

    Absolute count of cytotoxic T-cells (CD8+) in peripheral blood, measured by flow cytometry and expressed as cells/μL.

  3. CD4+/CD8+ Ratio

    Time frame: 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.

  4. Natural Killer (NK) Cell Count

    Time frame: Baseline

    Absolute count of Natural Killer (NK) cells in peripheral blood, measured by flow cytometry and expressed as cells/μL.

  5. EORTC QLQ-C30 Functional Scales Scores

    Time frame: 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.

  6. EORTC QLQ-C30 Symptom Scales Scores

    Time frame: 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.

  7. Anxiety Severity Score

    Time frame: 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.

  8. Sleep Disturbance Severity Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hebei Provincial Hospital of Traditional Chinese Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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