Colorectal Cancer (MSI-H)NCT07234682
Impact of Anxiety-Sleep Symptom Cluster on Immune Function and Quality of Life in Colorectal Cancer
An observational study of Colorectal Cancer (MSI-H) and Anxiety, run by Hebei Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (MSI-H), Anxiety
- What is being tested?
- standard-of-care chemotherapy
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, 050000
About this study
Official 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
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.
Read the 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
- Being tested
- standard-of-care chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard-of-care chemotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: standard-of-care chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (8)
CD3+ T-cell Count
Absolute count of total T-cells (CD3+) in peripheral blood, measured by flow cytometry and expressed as cells/μL.
Measured: Baseline
CD8+ T-cell Count
Absolute count of cytotoxic T-cells (CD8+) in peripheral blood, measured by flow cytometry and expressed as cells/μL.
Measured: Baseline
CD4+/CD8+ Ratio
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.
Measured: Baseline
Natural Killer (NK) Cell Count
Absolute count of Natural Killer (NK) cells in peripheral blood, measured by flow cytometry and expressed as cells/μL.
Measured: Baseline
EORTC QLQ-C30 Functional Scales Scores
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.
Measured: Baseline
EORTC QLQ-C30 Symptom Scales Scores
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.
Measured: Baseline
Anxiety Severity Score
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.
Measured: Baseline
Sleep Disturbance Severity Score
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jan 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xujin Guo, Hebei Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234682
- Sponsor's protocol ID
- HBZY2023-KY-050-01
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07234682
- Acronym / sponsor ID
- HBZY2023-KY-050-01
- Conditions
- Colorectal Cancer (MSI-H), Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hebei Provincial Hospital of Traditional Chinese MedicineOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom Cluster Group (n=45) | – | Other: standard-of-care chemotherapyPatients 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. |
| No/Low Symptoms Group (n=58) | – | Other: standard-of-care chemotherapyPatients who do not meet the criteria for the Symptom Cluster group (i.e., do not have both clinically significant anxiety and significant sleep disturbance). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard-of-care chemotherapyThis 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. | Other | No/Low Symptoms Group (n=58), Symptom Cluster Group (n=45) |
Primary outcome
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.
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.
8 secondary outcomes
CD3+ T-cell Count
Time frame: Baseline
CD8+ T-cell Count
Time frame: Baseline
CD4+/CD8+ Ratio
Time frame: Baseline
Natural Killer (NK) Cell Count
Time frame: Baseline
EORTC QLQ-C30 Functional Scales Scores
Time frame: Baseline
EORTC QLQ-C30 Symptom Scales Scores
Time frame: Baseline
Anxiety Severity Score
Time frame: Baseline
Sleep Disturbance Severity Score
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (MSI-H) and Anxiety, run by Hebei Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4+ T-cell Count (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.