Longitudinal Trajectories of Physical and Mental Health-Related Quality of Life Following Psychobiotic Supplementation in Gastrointestinal Oncology Patients: A Post Hoc Analysis of the ProDeCa Study

Background/Objectives: Patients undergoing surgery followed by adjuvant chemotherapy for gastrointestinal cancer frequently experience impaired health-related quality of life (HR-QoL). This post hoc analysis of the ProDeCa randomized trial investigated whether psychobiotic treatment was associated with longitudinal changes in HR-QoL.

Methods

Participants in the randomized, double-blind, placebo-controlled ProDeCa trial (NCT06496438) received either a four-strain psychobiotic formulation or placebo for four weeks during adjuvant chemotherapy. HR-QoL was assessed using the Short Form-36 (SF-36) questionnaire at baseline (V0), treatment completion (V1), and two months later (V2). Longitudinal changes in the eight SF-36 domains and the Physical (PCS) and Mental (MCS) Component Summary scores were analyzed using mixed models for repeated measures.