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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Yanlei Ma, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |