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

NCT07234682 | Completed

• 1 other identifier: HBZY2023-KY-050-01
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer (MSI-H); Anxiety

Outcome Measures

Primary Outcomes (2)

• CD4+ T-cell Count

  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.

  Baseline

• Global Health Status / Quality of Life Score

  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.

  Baseline

Secondary Outcomes (8)

• CD3+ T-cell Count

  Baseline

• CD8+ T-cell Count

  Baseline

• CD4+/CD8+ Ratio

  Baseline

• Natural Killer (NK) Cell Count

  Baseline

• EORTC QLQ-C30 Functional Scales Scores

  Baseline

Study Arms (2)

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.

Other: standard-of-care chemotherapy

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).

Other: standard-of-care chemotherapy

Interventions

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.

No/Low Symptoms Group (n=58); Symptom Cluster Group (n=45)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of stage II-IV colorectal cancer undergoing a standard chemotherapy regimen (e.g., FOLFOX, FOLFIRI) at the Hebei Provincial Hospital of Traditional Chinese Medicine.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, 050000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

A 5 mL peripheral blood sample was collected in an EDTA-containing tube for determination of absolute counts of T-lymphocyte subsets (CD3+, CD4+, CD8+) and natural killer (NK) cells.

MeSH Terms

Conditions

Colorectal Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: November 18, 2025
• Study Start: January 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

CN (1)