Impact of Anxiety-Sleep Symptom Cluster on Immune Function and Quality of Life in Colorectal Cancer (NCT07234682) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CD4+ T-cell Count
Timeframe: Baseline
2
Global Health Status / Quality of Life Score
Timeframe: Baseline
Trial details
NCT IDNCT07234682
SponsorHebei Provincial Hospital of Traditional Chinese Medicine