Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal … (NCT06443996) | Clinical Trial Compass
By InvitationNot Applicable
Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer
China500 participantsStarted 2023-08-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer;
✓. The United States Eastern Oncology Consortium (ECOG) physical status score was 0 to 2 points;
✓. 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;
✓. Able to complete the required research questionnaire independently or with the assistance of the researcher;
✓. 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;
✓. Patients and their families can understand and are willing to participate in this clinical study, and sign informed consent.
Exclusion criteria
✕. Under 18 years of age or over 80 years of age;
✕. Have a family history of severe mental illness;
✕. People with mental illness or intellectual disability who cannot correctly describe their feelings;
What they're measuring
1
Disease-free survival (DFS)
Timeframe: through study completion, an average of 1 year
2
Overall Survival
Timeframe: through study completion, an average of 1 year
3
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