A feasibility exploratory study of a novel modality of using patient-reported outcomes (PROsEXPLOR) in the real world.

Introduction: Patient-reported outcomes (PROs) can help clinicians better evaluate chemotherapy and immunotherapy toxicity based on patient perspectives. In this exploratory study, we tested a simplified PRO questionnaire (sPQ) in routine clinical practice and patient satisfaction with this tool. Methods: We included 16 items related to the main toxicities of chemotherapy and immunotherapy to be filled in by patients. A baseline sPQ was completed by patients before starting treatment and then in the interval between courses for a total of 4 sPQs. Patients communicated the results to a data manager, who alerted the referral oncologist in case of replies differing from the basal or previous sPQ. According to the severity of symptoms, the patient was then referred to the team nurse, the general practitioner, or another specialist. A satisfaction survey was also completed. Results: In a 3-month interval, 27 patients were enrolled. Fatigue and nausea were the most frequent symptoms reported as worsening during treatment. The oncologist was involved in the management of adverse events in 4 cases, home therapy variations were recommended by the dedicated nurse in 14 cases, additional visits were performed in 6 patients, and 1 patient was admitted to the oncology ward. None of the patients had unplanned visits to the emergency department or to the hospital. The sPQ was judged to be simple, useful, and satisfactory. Conclusions: Using sPQs in routine clinical practice was feasible and well-accepted by patients. PROs allowed us to recognize and promptly manage adverse events, reducing unplanned emergency department or hospital visits to zero.