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Background: Real world studies on the immunogenicity of BNT162b2 and mRNA-1273 in patients (pts) with cancer showed a reduced seroconversion. The aim of the study is to evaluate the immunogenicity and clinical efficacy of two doses of mRNA vaccines in cancer pts, during or after active treatment. Patients and Methods: This is a single institution, prospective, observational study, conducted at Luigi Sacco Hospital in Milan, IT. Seric antibody levels were measured in solid cancer pts and in healthy controls before the 1st dose (T0) and 30 days after the 2nd one (T1) by a fluorescence bead-based assay. Seroconversion (SR) was defined as anti-S and anti-RBD > 700 MFI (Median Fluorescence Intensity). Previous exposure was defined as anti-N >700 MFI (E-group: exposed;nonE-group: non exposed). Clinical efficacy was defined as the percentage of subjects who did not develop COVID-19 six months after the second dose. Result(s): 195 cancer pts: median age 64.1 y (Q1-Q3 53.8- 72.0);female 138 (70.8%);E-group (12.6%);active therapy 144 (86.7%);advanced stage of disease 131 (67.2%);breast cancer 100 (51.3%);chemotherapy 65 (33.3%), targeted therapy 69 (35.4%);multiple comorbidities 44 (22.6%);prophylaxis with G-CSF 15 (7.7%). 20 healthy subjects were enrolled as controls: median age 28.5 y (Q1-Q3 25.0-42.0), female 11 (55.0%). SR in nonEgroup was lower than in healthy controls (66.7% vs 95.0%, p=0.0085). Conversely, SR in E-group was comparable to healthy controls (93.3%, p=0.0020). In cancer pts, multiple comorbidities (p=0.0274) and the use of G-CSF (p=0.0151) negatively correlated with SR;mRNA-1273 induced a higher SR (p<0.0001). Clinical efficacy in pts was 97.4%. 7 pts were diagnosed for SARS-CoV-2 infection and confirmed by a RNA test. 5 pts developed COVID-19: 3 of them did not seroconvert at T1. COVID-19 disease was mild and managed at home. Only 1 hospitalization was recorded, but no ventilation or no intensive care admission was required. Conclusion(s): In our study, cancer pts with a previous SARS-CoV-2 infection showed a higher SR, similar to the one observed in healthy people. Besides, the presence of comorbidities and the use of G-CSF negatively affected the SR, while mRNA-1273 induced a higher SR. Interestingly, no COVID-19 serious complication or death were observed in all subgroups. Finally, as the third dose is the actual standard, identification of persistent non-responder pts is critical in order to select who could benefit of new treatments as monoclonal antibodies.
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Background: Despite of the administration of multiple doses of vaccines (vax), cancer patients (pts) are a group at high risk of COVID-19 complications. The aim of this study is to evaluate the factors associated with the humoral response to the 3rd dose (D) of mRNA-based vax in cancer pts during or after active treatment. Patients and Methods: Single institution, prospective study conducted at the L. Sacco Hospital, Milan, between 5/2021-4/2022. 30 days after the 2nd and 30 days after the 3rdD of BNT162b2 or mRNA-1273 (selected based on local pharmacy availability), seric levels of 3 antibodies (Ab) were measured in solid tumors pts during or after the active treatment, by a fluorescence bead-based assay. Anti-S and anti-RBD IgG to determine the humoral response to vax, anti-N IgG to identify a previous exposure to SARS-Cov-2. Primary objective: to assess the seroconversion (SC) rate and the Ab titres after 3rdD. Secondary Objectives: to detect any relation between the 3rdD response and pre-defined pts variables;to evaluate the humoral response to 3rdD in pts not responding to the 2ndD. Result(s): 99 of 110 pts were evaluated: 67.7% female, median age 63 ys, 49.5% breast cancer, 67.7% advanced stage. Active treatment: 40.4% biologic agent, 23% chemotherapy (alone or combination), 11.1% hormone. 3rdD vax type: 74.8% BNT162b2, 25.2% mRNA-1273. SC after 3rdD was obtained in 99% of pts. The use of GCSF was associated with a lower amount of anti-RBD IgG (p=0.03). A 6 vs 5 months interval between 2nd and 3rdD was correlated with higher anti-S IgG level (p<0.001). The heterologous vax regimen was associated with higher rate of anti-S IgG (p=0.04), especially the sequence mRNA- 1273 x 2 -> BNT162b2 (p=0.001). No significant correlation at the multivariate analyses was found between Ab levels and the other variables tested (age, BMI, cancer type, tumor stage, use of steroids, previous exposure to SARS-CoV-2, anti-cancer therapy, neutropenic potential of the therapy). 21/22 pts not responding to the 2ndD obtained SC after 3rdD. Conclusion(s): 3rdD of anti-COVID-19 vax is effective in cancer pts with solid tumors undergoing or after recent treatment. In this group the 3rdD oversteps all the negative influence of the factors related to the 2ndD vax failure, achieving the same response of the healthy population and demonstrating efficacy in not previously responders, too. The better performance of the heterologous vax regimen could be due to an exposition to a wider range of epitopes.
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INTRODUCTION: COVID-19 has disrupted the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population highly affected by the pandemic. This multicenter Italian study aimed to evaluate whether the COVID-19 outbreak had an impact on access to cancer diagnosis and treatment of LC pts compared with pre-pandemic time. METHODS: Consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were included. Access rate and temporal intervals between date of symptoms onset and diagnostic and therapeutic services were compared with the same period in 2019. Differences between the 2 years were analyzed using the chi-square test for categorical variables and the Mann-Whitney U test for continuous variables. RESULTS: A slight reduction (-6.9%) in newly diagnosed LC cases was observed in 2020 compared with 2019 (1523 versus 1637, P = 0.09). Newly diagnosed LC pts in 2020 were more likely to be diagnosed with stage IV disease (P < 0.01) and to be current smokers (someone who has smoked more than 100 cigarettes, including hand-rolled cigarettes, cigars, cigarillos, in their lifetime and has smoked in the last 28 days) (P < 0.01). The drop in terms of new diagnoses was greater in the lockdown period (percentage drop -12% versus -3.2%) compared with the other months included. More LC pts were referred to a low/medium volume hospital in 2020 compared with 2019 (P = 0.01). No differences emerged in terms of interval between symptoms onset and radiological diagnosis (P = 0.94), symptoms onset and cytohistological diagnosis (P = 0.92), symptoms onset and treatment start (P = 0.40), and treatment start and first radiological revaluation (P = 0.36). CONCLUSIONS: Our study pointed out a reduction of new diagnoses with a shift towards higher stage at diagnosis for LC pts in 2020. Despite this, the measures adopted by Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC pts.
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COVID-19 , Lung Neoplasms , Communicable Disease Control , Humans , Italy/epidemiology , Lung Neoplasms/diagnosis , Lung Neoplasms/epidemiology , Lung Neoplasms/therapy , PandemicsABSTRACT
Background: The coronavirus disease (COVID-19) has imposed an unprecedented challenge on the Health Care System. With the reallocation of crucial health resources to effectively exit the crisis, the pandemic has profoundly affected cancer patients' (pts) management. Breast cancer (BC) diagnosis results, especially in the early stage, from screening programs temporarily paused during COVID-19 outbreak. The aim of our multicenter study is to investigate the impact of COVID-19 on the likelihood of receiving timely diagnosis, staging and treatment for BC pts compared to pre-pandemic period. Material (patients) and methods: Medical records of all consecutive newly diagnosed BC pts referred to 4 Italian Oncology Departments between March and December 2020 were assessed. Monthly access rate and temporal intervals between date of symptoms onset, radiological, cytohistological diagnosis and treatment start were analyzed and compared with those of the same period in 2019. Differences between the two years were analyzed using Fisher's exact or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: A significant reduction (23%) in newly diagnosed BC pts was seen when compared with 2019 (552 vs 719). Newly BC pts in 2020 were less likely to be diagnosed with early stage (stage I-II) BC (77% vs 84%, p < 0.01), had a worsened ECOG PS (19% had PS > 0 in 2020 vs 16% in 2019, p = 0.15) and were more symptomatic at diagnosis (43% vs 23%, p < 0.01). Other clinical and tumor characteristics (such as histotype [p = 0.23] and molecular subtype [p = 0.71]) were similar regardless of the year. Looking at pts management, time intervals between symptom onset and radiological diagnosis (median 17 days in 2020 vs 21 in 2019, p = 0.04), symptom onset and cytohistological diagnosis (26 vs 35 days, p = 0.06), cytohistological diagnosis and treatment start (median 62 vs 76 days, p < 0.01) were maintained or even improved. However, less BC cases were discussed in multidisciplinary tumor meetings during the 2020 (52% vs 69%, p < 0.01). Conclusions: While the COVID-19 effects on cancer care will be likely felt for years to come, our data indicate a sharp decline in BC detection in 2020 with major impact on early stage diagnosis. Despite the upheaval generated by this global Health Care crisis, our study proves the effectiveness of the actions taken by Oncology Departments to guarantee diagnostic-therapeutic pathways.
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Background: Due to immunosuppression, influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a 4 times higher morbidity and mortality rates. Inadequate data are available about efficacy, safety, timing and immunogenicity of influenza (I) and pneumococcal (P) vaccine (vax) in pts undergoing active oncologic treatment. Nevertheless, the main Oncology societies recommend I and P vax in cancer pts and their family members (FMs). Materials and Methods: This is a single institution prospective study conducted at L. Sacco Hospital (Milan) between Sept 20 and Apr 21. The aim was to evaluate efficacy and safety of vax. Pts with diagnosis of tumor, age>18ys, in active antineoplastic treatment and FMs age>18ys were included. Each pt received I+P vax on the same day of therapy. Pts were compared with a control group of FMs, with age- and gender-adjusted logistic regression. Monthly monitoring was scheduled to register any Adverse Events (AEs) after injection (local and systemic AEs), episode of Influenza Like Illness (ILI), pneumococcal infection, access to Emergency department (ED) or Hospital admission (HA) and delay of treatment (DT). Results: 194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% =1 previous line of therapy;38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: 47% pts and 72% FMs received I-vax for first time. I+P-vax were administered in 100% pts and 49% FMs. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01), P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11);the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DT) and 3.6% FMs (p=0.04). No PI was recorded. Type of therapy, previous treatment and the use of steroid don't significantly impact on vax safety and efficacy. Conclusions: Despite the atypical season, I+P vax are safe and effective in cancer pts. The limited number of ILI events observed could be referred to vax but also to COVID-19 risk prevention and mitigation measures. No differences in efficacy and safety were observed between the 2 groups, except for local I-vax AEs. Moreover, the vax administration in the Oncology department, a wide vaccination coverage was achieved (>70% of cancer pts), reducing the pressure on territorial healthcare system.
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Background: Since March 2020, Coronavirus disease 2019 (COVID-19) has rapidly spread worldwide causing a massive Health Care crisis with Italy among the most affected countries. Oncology care has been widely derailed and cancer screening programs halted to effectively face the pandemic. Aim of our multicenter study is to assess how COVID-19 has impacted on the likelihood of receiving timely diagnosis, staging and treatment for colorectal cancer (CRC) patients (pts) during the 2020 compared to pre-pandemic period. Material (patients) and methods: All consecutive medical records of newly diagnosed CRC pts referred to 4 Italian Oncology Departments between March and December 2020 were evaluated. Monthly access rate and temporal intervals between date of symptoms onset, radiological and cytohistological diagnosis, treatment start and first radiological evaluation were analyzed and compared with the same months of 2019. Differences between the two years were evaluated using Fisher's exact or chisquare test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: A considerable drop (20%) in newly diagnosed CRC cases emerged compared to 2019 (214 vs 268). The lockdown period was more impacted by such decrease compared to the other months (percentage drop 40% vs 12%). New CRC diagnoses in 2020 were less likely to be diagnosed with early stage (stage I-II-III) CRC (67% vs 72%). Other clinical and tumor characteristics such as age, gender, sidedness and mutational status were similar regardless of the year. Looking at pts management, no differences were seen in terms of interval between symptom onset and radiological diagnosis (median 19 days in 2020 vs 28 days in 2019, p=0.88), symptom onset and cytohistological diagnosis (25 vs 36 days, p=0.27), symptom onset and treatment start (median 86 vs 100 days, p=0.79). However, less CRC were discussed in multidisciplinary tumor meetings during the 2020 (45% vs 54%, p=0.07). Conclusions: While COVID-19 effects on cancer pts' outcome might unfold in the years to come, our preliminary data show a remarkable drop in early stage CRC diagnoses throughout 2020. The Italian Oncology Departments managed to optimally tackle the quality care issue ensuring prompt diagnosis and treatment despite the pandemic evolving scenario. Further investigation, including larger case series, are warranted to offer a more exhaustive picture of the impact of COVID-19 emergency on cancer care.
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Background: The coronavirus disease 2019 (COVID-19) had an unprecedent impact on the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population, and diagnostic/therapeutic delays might affect the years to come. Aim of the multicenter, real-world, Italian COVID-DELAY study was to evaluate how the 2020 COVID-19 pandemic impacted on LC pts' access to diagnosis and treatment compared to pre-pandemic time. Patients and methods: All consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were reviewed. Monthly access rate and temporal intervals between date of symptom onset, diagnosis and treatment start were analyzed and compared to the same period of 2019. Differences between the two years were analyzed using Fisher's exact test or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: Less LC cases (1523 vs 1637, -6.9%) were diagnosed during the 2020 pandemic compared to 2019. LC pts in 2020 were more likely to be diagnosed with stage IV disease (p < 0.01) and to be current smokers (p < 0.01). A major drop of new LC cases was seen during the lockdown period (percentage drop -13.2% vs -5.1%) compared to the other months included. Moreover, a geographic migration was observed with more LC patients referring to low/ medium volume hospital in 2020 compared to 2019 (p = 0.01). Looking at pts management, no differences emerged in terms of interval between symptom onset and radiological diagnosis (p = 0.94), symptom onset and cytohistological diagnosis (p = 0.92), symptoms onset and treatment start (p = 0.40), treatment start and first radiological revaluation (p = 0.36). However, less LC patients were treated in the context of clinical trials during 2020 (5% vs 7%, p = 0.07). Conclusions: Our study pointed out a decrease of new LC cases and a shift towards a higher stage at diagnosis in 2020. Despite this, the efforts put in place by the Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC patients.
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Background: Influenza virus and S. pneumoniae infections in cancer patients (pts) are responsible of a higher morbidity and mortality rates. Limited data are available about safety, efficacy, immunogenicity and timing of influenza (I) and pneumococcal (P) vaccine (vax) in pts receiving active treatment. However, I and P vax in cancer pts and their family members (FMs) are reccomended. Methods: This is a single institution prospective study conducted at L. Sacco Hospital (Milan, Italy) between Sept 20 and Apr 21. The aim was to assess efficacy and safety of vax. Cancer pts, age>18yo, in active antineoplastic treatment and FMs age>18yo were included. Each pt received I+P vax on the same day of therapy. Any local and systemic Adverse Event (AE), episode of Influenza Like Illness (ILI), pneumococcal infection (PI), access to Emergency Department (ED) or Hospital admission (HA) and delay of therapy (DoT) were recorded. The frequency of AEs, ILI episodes and PI among pts and age- and gender- matching FMs were compared. Results: 194 pts (63y median age, 67.5% female) and 140 FMs (59y median age, 49% female) were enrolled. CANCER: 92% solid and 8% hematological malignancy, 69% metastatic stage. TREATMENTS: 54% ≥1 previous line of therapy;38% chemotherapy, 31% target, 17% chemo+target, 14% hormone therapy. VAX: I-vax received for first time in 47% pts and 72% FMs. 100% pts and 49% FMs received I+P-vax. LOCAL AEs: I-vax: 34% pts and 19.6% FMs (p=0.01). P-vax: 35.7% pts and 20.7% FMs (p=0.11). The most common was pain in site of injection. SISTEMIC AEs: 19.6% pts and 8.5% FMs (p=0.11);the most frequent was fatigue. EFFICACY: ILI were recorded in 8.8% pts (3 had a HA and 1 a DoT) and 3.6% FMs (p=0.04). No PI was recorded. In a logistic regression analysis type of therapy, previous treatment and the use of steroid don’t significantly impact on vax safety and efficacy. Conclusions: Few ILI events were observed due to vax and probably to all measures adopted to prevent SARS-CoV-2 virus spread. Except for local I-vax AEs, no differences were observed in efficacy and safety between the 2 groups. During the observation time, >70% of cancer pts in active treatment received I and P vax, so the vaccination coverage was achieved, reducing the pressure on territorial healthcare system. Clinical trial identification: Trial protocol n. 2020/ST/433 release by Local Ethic Committee. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: N.M. La Verde: Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: Pfizer;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Personal, Speaker’s Bureau: Gentili;Financial Interests, Institutional, Funding: EISA. D. Dalu: Financial Interests, Personal, Invited Speaker: Gentili;Financial Interests, Personal, Other: MSD. A. Riva: Financial Interests, Personal, Other: MSD,;Financial Interests, Personal, Other: ViiV;Financial Interests, Personal, Other: Gilead;Financial Interests, Personal, Other: Janseen;Financial Interests, Personal, Other: Cilag. S. Antinori: Financial Interests, Personal, Other: Pfizer;Financial Interests, Personal, Other: Merck. M. Galli: Financial Interests, Personal, Other: ViiV;Financial Interests, Personal, Other: BMS;Financial Interests, Personal, Other: MSD;Financial Interests, Personal, Other: AbbVie;Financial Interests, Personal, Other: Gilead;Financial Interests, Personal, Other: Janssen;Financial Interests, Personal, Other: Roche. All other authors have declared no conflicts of interest.
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Background: By the end of 2020, coronavirus disease 2019 (COVID-19) would have indelibly marked the cancer care setting. With Italy at the forefront of pandemic, unprecedented measures were adopted to tackle the quality care issue. As a result of pausing screening programs, diagnostic delays might affect the years to come. Aim of our multicenter Italian study is to evaluate whether the COVID-19 outbreak has impacted on likelihood of receiving timely diagnosis, staging and treatment for colorectal cancer (CRC) patients (pts) after March 2020 compared to pre-pandemic time. Methods: Medical records of all consecutive newly diagnosed CRC pts referred to 4 Italian Oncology Departments between March and December 2020 were examined. Access rate (number of pts/days) and temporal intervals between date of symptoms onset, radiological and cytohistological diagnosis, treatment start and first radiological evaluation were analyzed and compared with the same months of 2019. Differences between the two years were evaluated using Fisher’s exact test or chi-square test for categorical variables and unpaired Student t test, or the Mann-Whitney U test for continuous variables. Results: A reduction (20%) in newly diagnosed CRC cases was seen when compared with 2019 (214 vs 268). The decline was greater in the lockdown period compared to the other months (percentage drop 40 % vs 12%). Newly CRC pts in 2020 were less likely to be diagnosed with early stage (stage I-II-III) CRC (67% vs 72%). Other clinical and tumor characteristics were similar regardless of the year. Looking at pts management, no differences emerged in terms of interval between symptom onset and radiological diagnosis (median 19 days in 2020 vs 28 days in 2019, p = 0.88), symptom onset and cytohistological diagnosis (25 vs 36 days, p = 0.27), symptom onset and treatment start (median 86 vs 100 days, p = 0.79). However, less CRC were discussed in multidisciplinary tumor meetings during the 2020 (45% vs 54%, p = 0.07). Conclusions: While COVID-19 repercussions will be likely felt for decades to come, our data suggest an alarming drop in early-stage CRC diagnoses during the first pandemic year. Conversely, our study draws the attention on the efforts made to ensure diagnostic-therapeutic pathways proper operation. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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Background: COVID-19 pandemic led to a reorganization of Health Care System for cancer pts, also because of the application of containment measures. The aim of our study was to investigate the emotional discomfort of pts and their CGs who needed to access the day-hospital to receive treatment during pandemic. Methods: This is a single-institution, prospective, cross-sectional study. From 5th May to 5thJune 2020 a survey was conducted at a Department of Oncology in the midst of the Italian outbreak. We compared the points of view of both the 'players' through 2 different multiple-choice questionnaires enquiring demographic characteristics, changes in emotional status, interpersonal relationships with health professionals (HCPs) and self-perception of treatment outcomes. Results: 625 pts and 254 CGs were enrolled. Female were prevalent (pts:65%, CGs:56%). Pts were generally older than CGs (pts:70% > 60 y, CGs:50.4% 41-60 y;p < 0.001). 50.5% pts had a low education level (EL) while 67.5% CGs had a higher degree. About half of pts (52.8%) reached the hospital with their own CG who lived together in the 58.3% of cases. 52.5% of pts felt more vulnerable to COVID-19 compared to CGs. Differently, CGs did not feel more exposed to infection, although they were involved in taking care or lived together with pts. The EL influenced the risk contagion perception: people with a lower EL were less worried about being infected with SARS-CoV-2. Regardless of the perceived contagion risk, study participants considered the containment measures a valid support to avoid the spread of infection (pts:92%, CGs:89%;p = 0.163) without an excessive loss of time (pts:78%, CGs:88.6%;p = 0.003). A personal emotional change caused by waiting and performing visits/treatments alone was reported more by CGs (66%) than by pts (32.7%;p < 0.001). Specifically, CGs had greater anxiety (58.8%) and fear of not properly managing pts at home (19.8%). The majority of pts (73%) and CGs (62%) thought that the pandemic didn't influence treatment outcomes. The relationship with HCPs was not negatively affected for both pts (79.6%) and CGs (95%), but about a quarter of pts (25%) and CGs (29%) thought that the attention of HCPs was more focused on COVID-19 than on cancer treatment. Conclusions: The majority of pts felt at higher risk of COVID-19 infection and therefore approved the application of safety standards to help them feel more protected. Good relationships with HCPs contributed to receive treatments without experiencing additional distress. For CGs the main troubles are limitations which don't allow to fully share the pts' care route and the perceive an impairment in HCPs relationship. Starting from these data, we can better understand the current psychological distress of pts and their families in order to develop potential strategies to support them in this strenuous period of crisis.
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Background: Cancer patients (pts) during COVID-19 pandemic have to be protected because of higher morbidity and mortality risk. While follow up visits were rescheduled, frequently treatments couldn't be delayed without compromising efficacy. During pandemic, lockdown laws were approved and people were encouraged stay home. The aim of this study is to investigate the emotional discomfort of pts and their caregivers (CG), who need to access to Day Hospital to receive cancer treatment during pandemic. Materials and methods: This is a single-institutional experience of the Department of Oncology at Luigi Sacco Hospital, one of the most involved Italian hospitals by COVID-19 pandemic. From 5 May to 5 June 2020 we have conducted a survey on out-pts in active cancer therapy and their CG. We have set up 2 different multiple choice questionnaires (15 questions for pts and 17 for CG) enquiring demographic characteristic and changes in emotional status, interpersonal relationships with health professionals (HCPs) and self-perception of treatments outcomes. The answers could be yes, enough, no and I don't know;yes and enough were put together for data analysis. Results: 625 pts and 254 CG questionnaires were examined. 65.1% pts and 56.3% CG were female;69.8% pts were >60 ys while 50.4% CG were 41-60ys old. 40.1% of the pts vs only 25.6% CG think to be at greater risk of contagion because live together or access to the hospital. Both pts and CG consider containment measures (triage at the entrance, social distancing, personal protective equipment) a valid support to avoid the spread of infection (86.3% vs 85.4% respectively) without excessive loss of time (78.2% vs 88.6%). Waiting and performing visits and treatments without CG have no impact on emotional status of pts (64.4%), but generate in CG greater anxiety (58.8%) and fear of a bad home pts management (19.8%). The majority of pts (53.9%) and CG (39.4%) thinks pandemic doesn't influence treatments outcome. Relationships with HCPs was not negatively affected for 73.1% pts and 66.6% CG. Conclusions: The majority of pts believes to have an higher risk of contagion therefore approves the application of safety standards, that help them feel more protected. Moreover, good relationship with HCPs contributed to face treatments without additional distress. For CG the main trouble is limitations which don't allow to fully share the pts's care route and the perceive an impairment in HCPs relationship.
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BACKGROUND: Coronavirus disease 2019 (COVID-19) has rapidly spread to every country around the world taking on pandemic proportions. Since 8 March 2020, the Italian government ordered a nationwide lockdown with unavoidable social isolation. Healthcare professionals (HCPs) represent the most physically and emotionally involved category. The aim of this study is to assess the social distress among HCPs in Italy. PATIENTS AND METHODS: In this online, totally anonymous survey, 24 multiple choice questions were posed to medical staff employed in the Italian Healthcare System during the COVID-19 pandemic. Data collection was performed from 30 March to 24 April 2020. RESULTS: A total of 600 HCPs completed the questionnaire. The majority of respondents expressed the fear of being at higher risk of contagion than the general population (83.3%) and the weighty concern of infecting their families (72.5%). An insufficient supply of personal protective equipment (PPE; P = 0.0003) and inadequate training about procedures to follow (P = 0.0092) were seen to significantly coincide with these worries. More than two-thirds declared a change in family organisation, which showed a significant correlation with the concern of infecting their relatives (P < 0.0001). CONCLUSIONS: This is the first Italian survey on social distress among HCPs during the COVID-19 pandemic. The unavailability of PPE, screening procedures and adequate training strongly affected HCPs' emotional status. Although there was a predominance of oncologists (especially from the North of Italy), which impairs the generalisation of our findings, this survey underlined the social impact that this health emergency has had on HCPs.
Subject(s)
COVID-19 , Oncologists/psychology , Stress, Psychological/epidemiology , Adult , Aged , Anxiety , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Fear , Female , Health Personnel/psychology , Health Surveys , Humans , Italy/epidemiology , Male , Middle Aged , Personal Protective EquipmentABSTRACT
Background: During COVID-19 pandemic, cancer patients (pts) have to be protected because of higher morbidity and mortality risk. While follow up visits were rescheduled, frequently treatments couldn’t be delayed without compromising efficacy. The aim of this study is to investigate the emotional discomfort of out-patients and their caregivers (CG), who needed access to hospitals to receive cancer treatment during the pandemic. Methods: This is a single-institutional experience of the Department of Oncology at L. Sacco Hospital, one of the Italian hospitals most affected by COVID-19 pandemic. From 5 to 15 May 2020 we conducted a survey on out-patients in active cancer therapy and their CG. We created two different multiple-choice questionnaires (15 questions for pts, 17 for CG) looking at demographic characteristics and changes in emotional status, interpersonal relationships with health professionals (HCPs) and self-perception of treatment outcomes. The answers could be yes, enough vs no, I don't know. Results: Questionnaires from 332 pts and 117 CG were examined. 65.1% pts and 53% CG were female;65.7% of pts were >60 ys old and 55.6% of CG were between 41-60 ys. 48.7% of pts vs only 27.4% CG thought to be at greater risk of infection because of living together or visiting the hospital. Both pts and CG considered containment measures (triage at hospital entrance, social distancing, personal protective equipment) as valid support to avoid the spread of infection (87% vs 82%, respectively) without excessive loss of time (79.8% vs 86.3%). Waiting and performing visits and treatments without CG had no impact on emotional status of pts (67.3%), but generated greater anxiety in CG (59.7%) and fear of poor patient management at home (17.7%). The majority of pts (52.6%) and CG (37.6%) did not think that the pandemic influenced treatment outcome. Relationships with HCPs was not negatively affected for 75% pts and 51% CG. Conclusions: The majority of pts believed they had a higher risk of COVID-19 infection and therefore approved the application of safety standards to help them feel more protected. Good relationships with HCPs contributed to receive face-to-face treatments without experiencing additional distress. For CG the main issues were limitations in sharing of pts' care routines and the perceived impairment in relationships with HCPs. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: N.M. La Verde: Honoraria (self): Eisai;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Gentili;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy: Novartis, Celgene, MSD. All other authors have declared no conflicts of interest.