BACKGROUND: Patients with colorectal cancer frequently experience sleep disturbance, psychological distress, and impaired quality of life after surgery. These symptoms are interrelated through inflammatory and neuroendocrine pathways but are rarely addressed using integrated interventions.
METHODS: We conducted a prospective, single-center randomized controlled trial at the First Affiliated Hospital of Soochow University (September 2021-September 2023). A total of 300 patients with stage I-III colorectal cancer were randomized (1:1) to standard oncological care or to a combined intervention including sleep hygiene education, relaxation training, stimulus control, and cognitive-behavioral therapy-based psychological support. Outcomes included Pittsburgh Sleep Quality Index (PSQI), Visual Analog Scale (VAS) pain, Zung Anxiety (SAS) and Depression (SDS) scales, and EORTC QLQ-C30 Global Health/Quality of Life (GHS/QL). Analyses followed the intention-to-treat principle, with multiple imputation for missing data and analysis of covariance (ANCOVA) adjusted for baseline scores.
RESULTS: Of 356 patients screened, 300 were randomized (150 per group). At 3 months, the intervention group showed greater improvement in PSQI (aMD - 7.5, 95% CI - 8.4 to - 6.6, p < 0.001), VAS pain (aMD - 3.2, 95% CI - 3.6 to - 2.8, p < 0.001), SAS (aMD - 13.2, 95% CI - 14.7 to - 11.7, p < 0.001), and SDS (aMD - 13.5, 95% CI - 15.1 to - 12.0, p < 0.001). Global quality of life improved significantly (aMD + 12.5, 95% CI + 10.9 to + 14.1, p < 0.001). All changes exceeded minimal clinically important differences. Intervention adherence was high (93.3%), and no adverse events occurred.
CONCLUSION: An integrated program of sleep and psychological interventions produced clinically and statistically significant improvements in postoperative sleep quality, pain, anxiety, depression, and overall quality of life in colorectal cancer patients. This safe, feasible, and replicable strategy may complement enhanced recovery after surgery (ERAS) protocols and warrants multicenter evaluation with extended follow-up.
