Study outcome measures
nausea, dyspnea, fatigue, diarrhea, pain, constipation, insomnia, gastrointestinal or urogenital toxicity
APPETITE LOSS, SECONDARY
The primary objective of the APROVE trial was to assess the feasibility, safety, and treatment tolerability of postoperative pelvic proton beam therapy, which was defined as the lack of any CTCAE grade ≥ 3 gastrointestinal or urogenital toxicity or early therapy cessation. The detailed results relating to these parameters are presented separately. The current analysis describes the secondary endpoints of HRQOL and patient-reported symptoms at baseline and up to 2 years after proton beam therapy.Patient-reported HRQOL was assessed using the EORTC QLQ-C30 (version 3.0) questionnaire with scoring of the global health status (in which higher scores represent higher HRQOLs), a functional scale of five items (physical, role, cognitive, emotional, and social; higher scores represent higher levels of functioning) and a symptom scale of nine items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties; in which higher scores represent higher levels of problems) [