Clinical trial · Observational
Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer
Effects of Sleep Quality and Mental Status on Early Postoperative Recurrence and Prognosis in Patients With Colorectal Cancer: a Prospective Observational Cohort Study
NCT06443996CI-TRIAL-00077742enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective observational cohort study to explore the effects of sleep quality and mental status on early postoperative recurrence and prognosis in patients with colorectal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Mental Status Change | — | UNRESOLVED | — |
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Disease-free survival (DFS)
- timeFrame
- through study completion, an average of 1 year
- description
- The duration between the date after surgery to the date of any recurrence or death firstly
- measure
- Overall Survival
- timeFrame
- through study completion, an average of 1 year
- description
- Time from the start of surgical randomization to death (from any cause)
- measure
- Effect of sleep quality and mental state on early recurrence and prognosis of patients with colorectal cancer after surgery
- timeFrame
- through study completion, an average of 1 year
- description
- The correlation of GAD-7 scale score, PHQ-9 scale score and ESAS scale score with Disease-free survival (DFS), Overall Survival and tumor-free survival rate of patients was analyzed
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer; 2. Age 18 \~ 80 years old; 3. Baseline clinical stage TNM Ⅰ to Ⅲ : cT1-4N0-2M0 (AJCC-8 version); 4. The United States Eastern Oncology Consortium (ECOG) physical status score was 0 to 2 points; 5. Laboratory examination results before admission met the following surgical conditions: neutrophil (ANC) ≥1.5×109/L, platelets (PLT) ≥ 100×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal (2mg/dl), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2× upper limit of normal; Coagulation parameters in the normal range; 6. Able to complete the required research questionnaire independently or with the assistance of the researcher; 7. Patients were willing to undergo regular follow-up after surgery and had no psychological, family, social, or geographic constraints that affected protocol compliance and follow-up time; 8. Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent. Exclusion Criteria: 1. Under 18 years of age or over 80 years of age; 2. Have a family history of severe mental illness; 3. People with mental illness or intellectual disability who cannot correctly describe their feelings; 4. The patient has severe systemic infection; 5. No radical operation was performed during the operation due to various reasons; 6. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery; 7. Merge other parts of the transfer; 8. Have serious heart, lung, liver and kidney diseases, can not tolerate surgery; 9. Active stage of liver disease or abnormal liver function, ALT, AST, TBIL is more than 2 times the upper limit of normal value; 10. Renal function damage, Cr ≥ 2 times the upper limit of normal value or BUN ≥ 2 times the upper limit of normal value; 11. The subject's blood white blood cells are lower than the lower limit of normal, or platelets are lower than the lower limit of normal, or there are other blood system diseases; 12. Severe coagulation mechanism disorder and bleeding tendency; 13. Serious uncontrolled medical disease, recent history of myocardial infarction (within 3 months); Acute infection; 14. Patients with uncontrolled severe hypertension and severe diabetes after intervention; 15. The researchers considered that other candidates were not suitable for inclusion in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.