ABSTRACT
Background: One of WALCE's aims is to increase the awareness of people with lung cancer and provide them educational initiatives. It has been recently investigated patients' knowledge and attitudes towards clinical trials in order to gain better insights from their experience. Material(s) and Method(s): from January to April 2022, an anonymous questionnaire with 22 multiple-choice and 4 open-ended questions was carried out by WALCE. Result(s): 109 patients from 7 Italian cancer centers have filled out the questionnaire. 58% were women and the average age was 62 years. 86% have heard about clinical trials and 90% said to be interested in knowing more about them, but only 46% acknowledged to have looked for information, using different top sources. The majority of patients prioritized their oncologists (44% of cases), over consulting websites (31%), magazines (11%), family and friends (9%) and social media (8%), they've got it during the news about COVID (7%), or by other medical specialists (6%) and patient associations (5%) and more than half of patients (83%) confirmed to have found the information they were looking for (even if 39% only "sometimes"). However, 66% believe their level of knowledge about it is still poor (i.e. 84% are not aware of the different trail phases). At the same time, 72%said to be more inclined to participate in a clinical trial after the COVID Vaccine and 88% were interested to know more about them. According to 97% of patients, clinical trials generate data about safety (47%), efficacy (40%) and prognosis (27%), only 6% answered that the objective is to evaluate the costs of clinical procedures. Only 26% participated in a trial, but 50% would have liked to and "hope" was the reason for half of them, while the remaining 50% preferred not to participate because of fear and lack of information (16% of cases). The collaboration between researchers and patients is considered beneficial by 73% of the respondents, mainly to bring out the needs of patients (41% of the cases). Finally, 85% are willing to receive more information about clinical trials by newsletters (54%) or through the oncologists (18%). Conclusion(s): the survey has highlighted the need of lung cancer patients to receive more comprehensive information about clinical trials and to cooperate with researchers to include the voice of patients.
ABSTRACT
Background: Soon after the Italian Medicine Agency (AIFA) authorized the first mRNA COVID-19 vaccine, BNT162b2 (ComirnatyR), the Italian Ministry of Health launched a national vaccination campaign. Giving the high risk of mortality from COVID-19, cancer patients were considered a priority group. However, data about BNT162b2 safety in this population are still lacking and the impact on patients' psychological state and social life was not studied. Herein we describe the adverse events (AE) related to the vaccine and the subjective experience of cancer patients treated and vaccinated at San Luigi Gonzaga University Hospital. Materials and methods: All cancer patients who accepted to participate in our campaign were vaccinated with BNT162b2 and included in the descriptive analysis. Patients who tested positive for COVID-19 after January 1st, 2021 were not recruited. An anonymous questionnaire about AE and psycho-social impact of the vaccination was administered to the study population 21 days after the first dose. The short-term AE reported after the second dose were investigated via a telephone questionnaire. Results: A total of 997 patients were included in the study, of whom 618 were affected by advanced cancer. At the time of the vaccination, 223 patients were receiving chemotherapy and/or immunotherapy. 49 patients have been infected and recovered from COVID-19. AE were reported in 37.3% cases after the first dose and in 48.5% cases after the second dose. The most common AE were muscle pain (26.7% and 27.4%, after the first and second dose respectively) and fatigue (10.4% and 16.8%). No severe AE had been reported. Before receiving the vaccine, 18% patients felt fearful and/or insecure about the vaccination, while 76.4% felt hopeful and/or enthusiast. After the first dose, 57.5% patients changed their feelings positively and 79.5% patients stated to feel much more confident in their social life. Patients' opinion about the vaccination was mainly influenced by the specialist/family doctor (38.7%) and by mass-media (25.8%), and the information they were given was considered adequate by 86% patients. Conclusions: Our data support the short-term safety of BNT162b2 in cancer patients, regardless of the disease staging and the concurrent treatment. Before the vaccination, most of our patients consulted the specialist or the family doctor receiving adequate information and being reassured. Moreover, the vaccination showed a positive psychological and social impact.