CompletedNot Applicable

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

China103 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

CD4+ T-cell Count

Timeframe: Baseline

Global Health Status / Quality of Life Score

Timeframe: Baseline

Trial details

NCT IDNCT07234682

SponsorHebei Provincial Hospital of Traditional Chinese Medicine

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Colorectal Cancer (MSI-H) trials