Dissertação de Mestrado Gestão da Investigação Clínica 2023 Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Introduction: Lung cancer is one of the most common oncological diseases in the world, and the use of immunotherapy is a substantial progress in terms of new therapeutic options. Fatigue is the most frequently reported adverse effect in patients who start treatment with immunotherapy, but it remains underdiagnosed. Objectives: The aim of this study is to identify whether the assessment of fatigue recorded by the clinical team at the pneumology consultation is consistent with the Non Small Cell Lung Cancer (NSCLC) patients report when answering the BFI questionnaire during treatment with immunotherapy in monotherapy or in combination with chemotherapy.Methods: A prospective observational study was carried out during 8 months. The research was conducted through the collection of medical records from the patients clinical files and the application of the Brief Fatigue Inventory questionnaire before each one of the 4 treatment cycles. This questionnaire was validated and linguistically translated into portuguese and assesses the severity and functional impact of fatigue in cancer patients. A 95% confidence interval was considered. Results: The sample composed of 31 patients, presented 26 male (84%) and 5 female (16%) with a mean age of 68.5 years. The mean value of the BFI score before the first treatment, as well as in the following 3 evaluations, was higher for the participants who presented symptoms of asthenia/tiredness/fatigue recorded in the clinical files at the consultation and lower for those who did not. However, the differences were not statistically significant (pre 1st treatment - p=0.299, pre 2nd treatment - p=0.125, pre 3rd treatment - p=0.103 and pre 4th treatment - p=0.954). By comparing the BFI score with medical records, we found that fatigue remained underreported at the consultation in different assessment times (71% of sample participants were not identified as having fatigue at the 1st assessment time; 60% at the pre 2nd treatment visit; 54% at the pre 3rd treatment visit and 40% at the pre 4th treatment visit). Conclusions: In the present study, the benefits of applying the BFI questionnaire were relevant. This tool allowed us to identify and stratify fatigue, showing greater sensitivity when compared to the medical records of the consultation alone. The fact that the study sample was small is a limitation and made it difficult to obtain more robust results. Therefore, it is desirable to conduct further long-term prospective studies be carried out in this area, in order to consolidate the results found in this research.