Association of Sleep Quality and Mental Status With Early Recurrence and Prognosis of Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06443996
• Other study ID #: FDCRC97-MYL
• Status: Enrolling by invitation
• Start date: August 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer;

2. Age 18 ~ 80 years old;

3. Baseline clinical stage TNM ? to ? : 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Mental Status Change
• Recurrence
• Sleep Quality

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ma Yanlei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	The duration between the date after surgery to the date of any recurrence or death firstly	through study completion, an average of 1 year
Primary	Overall Survival	Time from the start of surgical randomization to death (from any cause)	through study completion, an average of 1 year
Primary	Effect of sleep quality and mental state on early recurrence and prognosis of patients with colorectal cancer after surgery	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	through study completion, an average of 1 year
Secondary	Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study.	Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study. 1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.	From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study.	Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study. 1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.	From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Physical examination was used to determine recurrence in patients with colorectal cancer	Physical examination was used to determine recurrence in patients with colorectal cancer.1, 3, 6, 12, 18, 24 months after the operation until the observation endpoint appeared.	From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months