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

NCT06443996 | Enrolling By Invitation

• 1 other identifier: FDCRC97-MYL
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Sleep Quality; Mental Status Change

Outcome Measures

Primary Outcomes (3)

• 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

• Overall Survival

  Time from the start of surgical randomization to death (from any cause)

  through study completion, an average of 1 year

• 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 Outcomes (3)

• Tumor markers CEA, CA19-9 was used to determine recurrence in patients with colorectal cancer enrolled in the study.

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

• Enteroscope was used to determine recurrence in patients with colorectal cancer enrolled in the study.

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

• Physical examination was used to determine recurrence in patients with colorectal cancer

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Preoperative fibrocolonoscopy and pathological examination confirmed colorectal cancer;
• Age 18 \~ 80 years old;
• Baseline clinical stage TNM Ⅰ to Ⅲ : cT1-4N0-2M0 (AJCC-8 version);
• 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.

You may not qualify if:

• 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;
• The patient has severe systemic infection;
• No radical operation was performed during the operation due to various reasons;
• Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, peritonitis, etc. requiring emergency surgery;
• Merge other parts of the transfer;
• Have serious heart, lung, liver and kidney diseases, can not tolerate surgery;
• Active stage of liver disease or abnormal liver function, ALT, AST, TBIL is more than 2 times the upper limit of normal value;
• Renal function damage, Cr ≥ 2 times the upper limit of normal value or BUN ≥ 2 times the upper limit of normal value;
• 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;
• Severe coagulation mechanism disorder and bleeding tendency;
• Serious uncontrolled medical disease, recent history of myocardial infarction (within 3 months); Acute infection;
• Patients with uncontrolled severe hypertension and severe diabetes after intervention;

Sponsors & Collaborators

• Ma Yanlei: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yanlei Ma, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 5, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

CN (1)