Ethics and research design
Cancer
CANCER
The intervention and the filling in of the questionnaires took place during the hospitalization in the surgical department and during the visit to the oncological day hospital and/or to the “Alte Energie” Center of the Oncological Radiotherapy Department of the Clinical Institute of S. Anna in Brescia — San Donato Group. The project was approved by the Ethics Committee of the Clinical Institute of S. Anna in Brescia (Prot. Number: 2016.1.1; June 6, 2016).The questionnaires were labeled with an alphanumeric code, the combination of which was known only to the nursing staff responsible for randomization. The medical staff and the researchers who performed the data analysis were blinded to this information.The research design was a randomized, prospective study with triple data collection according to the steps of the clinical intervention: preoperative phase (T0), initial phase of treatments (T1), and 3 months after the start of treatments (T2) (Table In the pre-study phase, nurses informed patients of the opportunity to participate in the research project, obtained informed consent, and performed randomization using the online software Research Randomizer (version 4.0). The Symptom Checklist-90-R (SCL-90-R) was used only at T0 and T2 because it was considered a specific and primary tool for evaluating the FRIPOS program by assessing symptom indices at baseline and at the end of the project. At T1 and T2, patients completed two quality of life (QLQ) questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC), namely C-30 and BR-23.