Integrated psychosocial, sleep, and immunonutritional intervention improves psychological adaptation, sleep disturbance, and inflammatory activation in rectal cancer: a randomized controlled trial.

BACKGROUND

Patients undergoing abdominoperineal or intersphincteric resection for low rectal cancer experience profound physiological and psychological stress. Conventional Enhanced Recovery After Surgery (ERAS) protocols mainly address surgical and metabolic factors but rarely target the host's psychosocial and immunometabolic recovery.

STUDY

DESIGN

In this single-center randomized controlled trial, 240 patients with stage II-III low rectal cancer (September 2019-September 2021) were randomized (1:1) to receive either standard ERAS care or an integrated perioperative intervention combining resilience-based psychosocial support, cognitive behavioral therapy for insomnia, and Prognostic Immune Nutritional Index (PINI)-guided nutritional optimization. The primary outcomes were global quality of life (EORTC QLQ-C30) and sleep quality (Pittsburgh Sleep Quality Index). The secondary outcomes included postoperative recovery, inflammatory and nutritional indices, and 3-year disease-free and overall survival.

RESULTS

At 12 months, the intervention group showed greater improvement in quality of life (mean difference = 12.3, 95% CI 8.6-16.0; p < 0.001) and sleep quality (-3.1, 95% CI -4.5 to -1.8; p < 0.001). Serum interleukin-6 declined more rapidly (-1.9 pg/mL vs -0.8; p < 0.001), accompanied by improved PINI (-0.7; p < 0.01) and higher fecal short-chain fatty acid levels (+ 10.6 mmol/kg; p < 0.001). Three-year disease-free survival favored the intervention (HR 0.69, 95% CI 0.51-0.93; p = 0.015). No intervention-related serious adverse events occurred.

CONCLUSIONS

Integrating psychosocial, sleep, and immunonutritional components into perioperative care enhanced functional and physiological recovery after low rectal cancer surgery. These findings support extending ERAS toward targeted modulation of host response to improve both short- and long-term outcomes.