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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Under 18 years of age or over 80 years of age;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disease-free survival (DFS)

Timeframe: through study completion, an average of 1 year

Overall Survival

Timeframe: 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

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06443996

SponsorMa Yanlei

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Colorectal Cancer trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. Under 18 years of age or over 80 years of age;

What they're measuring

Disease-free survival (DFS)

Timeframe: through study completion, an average of 1 year

Overall Survival

Timeframe: 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

Timeframe: through study completion, an average of 1 year