Clinical trial NCT06443996: Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer
Official title: Effects of Sleep Quality and Mental Status on Early Postoperative Recurrence and Prognosis in Patients With Colorectal Cancer: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer
Sleep Quality
Mental Status Change
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were diagnosed with colorectal cancer by histopathology at the Affiliated Cancer Hospital of Fudan University and underwent surgery for colorectal cancer at the Affiliated Cancer Hospital of Fudan University

Brief 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.

Detailed description: Evidence of evidence-based medicine shows that patients with malignant tumors have heavy psychological pressure after disease, and are prone to different degrees of sleep disorders and mental health problems, which often affect the progression and prognosis of the primary tumor. Previous studies have reported that baseline sleep quality was independently associated with risk of progression, risk of death, and response to treatment in patients with metastatic colorectal cancer before and during chemotherapy. Surgery, as a stressor, often causes obvious psychological stress reactions in patients, resulting in varying degrees of sleep disorders and poor mental performance, which may also become a factor affecting the recurrence and prognosis of patients. Therefore, the Department of Colorectal Surgery, Affiliated Cancer Hospital of Fudan University intends to conduct a prospective observational cohort study on the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer, in order to explore the effects of sleep quality and mental state on early postoperative recurrence and prognosis of patients with colorectal cancer.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: through study completion, an average of 1 year
measure: Overall Survival
timeFrame: through study completion, an average of 1 year
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
Secondary outcomes:
measure: Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study.
timeFrame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
measure: Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study.
timeFrame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
measure: Physical examination was used to determine recurrence in patients with colorectal cancer
timeFrame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Yanlei Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References: