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Background Despite evidence of the positive impact of routine assessment of patient-reported outcome measures (PROMs), their systematic collection is not widely implemented in cancer care. Aim To assess the knowledge, use and attitudes of healthcare professionals (HCPs) towards PROMs and electronically collected PROMs (ePROMs) in clinical practice and research and to explore respondent-related factors associated with the above dimensions. Method An ad hoc developed online survey was administered to all HCPs employed in clinical activity in an Italian comprehensive cancer center. The survey investigated which PROMs were known and used, as well as HCPs’ opinions on the advantages and drawbacks of routine PROM assessment, including electronic assessment (ePROM). Linear and logistic regression models were used for association analyses. Results Five Hundred Eleven of nine hundred ninety-two invited HCPs (52%) provided analyzable responses. 68% were women, 46% were nurses and 42% physicians, and 52.5% had > 20 years seniority. The average number of PROMs known was six among 17 proposed. All proved to be under-used (< 28%) except unidimensional and multidimensional pain scales (77 and 36%). Respondents expressed an overall positive attitude towards PROMs, with strengths outweighing weaknesses (mean overall scores 3.6 and 2.9, respectively, on a 1–5 scale). 67% of respondents preferred electronic collection over paper and pencil. Profession was associated with knowledge and use (physicians reported knowing more PROMs than other professionals) and with a preference for electronic collection (nurses were less likely to prefer the electronic format than physicians). Senior HCPs were slightly more critical about both PROMs and electronic administration. Conclusions This survey indicates an acceptable level of knowledge of common PROM tools but low usage in practice. Based on the generally positive attitude of HCPs, routine implementation of ePROMs can be promoted as long as adequate resources and training are provided. Trial registration Not registered.

Background Listening to “patient voices” in terms of symptoms, emotional status and experiences with care, is crucial for patient empowerment in clinical practice. Despite convincing evidence that routine patient reported outcomes and experience measurements (PRMs) with rapid feed-back to oncologists can improve symptom control, patient well-being and cost effectiveness, PRMs are not commonly used in cancer care, due to barriers at various level. Part of these barriers may be overcome through electronic PRMs collection (ePRMs) integrated with the electronic medical record (EMR). The PATIENT VOICES initiative is aimed at achieving a stepwise integration of ePRMs assessment into routine cancer care. The feasibility project presented here is aimed at assessing the knowledge, use and attitudes toward PRMs in a comprehensive cancer centre; developing and assessing feasibility of a flexible system for ePRM assessment; identifying barriers to and developing strategies for implementation and integration of ePRMs clinical practice. Methods The project has been organized into four phases: a) pre-development; b) software development and piloting; c) feasibility assessment; d) post-development. A convergent mixed method design, based on concurrent quantitative and qualitative data collection will be applied. A web-survey on health care providers (HCPs), qualitative studies on patients and HCPs (semi-structured interviews and focus groups) as well as longitudinal and cross-sectional quantitative studies will be carried out. The quantitative studies will enroll 600 patients: 200 attending out-patient clinics (physical symptom assessement), 200 attending inpatient wards (psychological distress assessment) and 200 patients followed by multidisciplinary teams (patient experience with care assessment). The Edmonton symptom assessment scale, the Distress Thermometer, and a tool adapted from existing patient reported experience with cancer care questionnaires, will be used in quantitative studies. A multi-disciplinary stakeholder team including researchers, clinicians, health informatics professionals, health system administrators and patients will be involved in the development of potentially effective implementation strategies in the post development phase. Discussion The documentation of potential advantages and implementation barriers achieved within this feasibility project, will serve as a starting point for future and more focused interventions aimed at achieving effective ePRMs routine assessment in cancer care. Trial registration ClinicalTrials.gov ( NCT03968718 ) May 30th, 2019.

\"Patient Voices\" is a software developed to promote the systematic collection of electronic patient-reported outcome measures (ePROMs) in routine oncology clinical practice. This study aimed to assess compliance with and feasibility of the Patient Voices ePROM system and analyze patient-related barriers in an Italian comprehensive cancer center. Consecutive patients with cancer attending 3 outpatient clinics and 3 inpatient wards were screened for eligibility (adults, native speakers, and being able to fill in the ePROMs) and enrolled in a quantitative and qualitative multimethod study. Compliance, reasons for not administering the ePROMs, patients' interaction needs, and patient-perceived System Usability Scale (range 0-100) were collected; semistructured interviews were carried out in a subsample of patients. From June 2020 to September 2021, a total of 435 patients were screened, 421 (96.7%) were eligible, and 309 completed the ePROMs (309/421, 73.4%; 95% CI 69.8%-77.5%; mean age 63.3, SD 13.7 years). Organization problems and patient refusal were the main reasons for not administering the ePROMs (outpatients: 40/234, 17.1% and inpatients: 44/201, 21.9%). Help for tablet use was needed by 27.8% (47/169) of outpatients and 10.7% (15/140) of inpatients, while the support received for item interpretation was similar in the 2 groups (outpatients: 36/169, 21.3% and inpatients: 26/140, 18.6%). Average System Usability Scale scores indicated high usability in both groups (outpatients: mean 86.8, SD 15.8 and inpatients: mean 83.9, SD 18.8). Overall, repeated measurement compliance was 76.9% (173/225; outpatients only). Interviewed patients showed positive attitudes toward ePROMs. However, there are barriers to implementation related to the time and cognitive effort required to complete the questionnaires. There is also skepticism about the usefulness of ePROMs in interactions with health care professionals. This study provides useful information for future ePROM implementation strategies, aimed at effectively supporting the routine clinical management and care of patients with cancer. In addition, these findings may be relevant to other organizations willing to systematically collect PROMs or ePROMs in their clinical routines. ClinicalTrials.gov NCT03968718; https://clinicaltrials.gov/study/NCT03968718.

The coronavirus disease 2019 pandemic still represents a global public health emergency, despite the availability of different types of vaccines that reduced the number of severe cases, the hospitalization rate and mortality. The Italian Vaccine Distribution Plan identified healthcare workers (HCWs) as the top-priority category to receive access to a vaccine and different studies on HCWs have been implemented to clarify the duration and kinetics of antibody response. The aim of this paper is to perform a literature review across a total of 44 studies of the serologic response to COVID-19 vaccines in HCWs in Italy and to report the results obtained in a prospective longitudinal study implemented at the Fondazione IRCCS Istituto Nazionale Tumori (INT) of Milan on 1565 HCWs. At INT we found that 99.81% of the HCWs developed an antibody response one month after the second dose. About six months after the first serology evaluation, 100% of the HCWs were still positive to the antibody, although we observed a significant decrease in its levels. Overall, our literature review results highlight a robust antibody response in most of the HCWs after the second vaccination dose. These figures are also confirmed in our institutional setting seven months after the completion of the cycle of second doses of vaccination.

ObjectivesDuring the COVID-19 pandemic, telemedicine (TM) emerged as an important mean to reduce risks of transmission, yet delivering the necessary care to patients. Our aim was to evaluate feasibility, characteristics and satisfaction for a TM service based on phone/video consultations for patients with cancer attending an outpatient palliative care clinic during COVID-19 pandemics.MethodsA longitudinal observational study was conducted from April to December 2020. Consecutive patients were screened for video consultations feasibility. Either patients or their caregivers received video/phone consultations registering reason and intervention performed. Those contacted at least twice were eligible for experience of care assessment.ResultsVideo consultations were feasible in 282 of 572 screened patients (49%, 95% CI 45% to 52%); 112 patients among the 572 had at least two phone/video consultations and 12 of them had one or more video consultations. Consultations were carried out with patients (56%), caregivers (30%) or both (14%). 63% of the consultations were requested by the patients/caregivers. Reasons for consultation included uncontrolled (66%) or new symptom onset (20%), therapy clarifications (37%) and updates on diagnostic tests (28%). Most interventions were therapy modifications (70%) and appointments’ rescheduling (51%). 49 patients and 19 caregivers were interviewed, reporting good care experience (average of 1–5 satisfaction score of 3.9 and 4.2, respectively). The majority (83% and 84%) declared they would use TM after the pandemics.ConclusionsAlthough feasibility is still limited for some patients, TM can be a satisfactory alternative to in-person visits for palliative care patients in need of limiting access to the hospital.

Identifying predictive and resistance biomarkers remains one of the most relevant unmet needs in clinical cancer research. Artificial Intelligence (AI) represents a powerful tool to develop predictive algorithms tailored to individual patients. Thanks to its ability to process large quantities of heterogeneous, patient-level information, the AI-based approach is progressively fostering the growth of a data-driven paradigm to complement traditional, hypothesis-driven clinical research. However, the development of reliable AI models requires access to large, high-quality, and continuously updated datasets. Despite this necessity, no infrastructure currently exists to enable federated, multi-omic, standardized, prospective, and large-scale collection and analysis of real-world clinical and biological data in the context of lung cancer. We established the APOLLO11 consortium, a distributed, nationwide, updated Italian lung cancer network designed to build a decentralized, long-term, population-based, real-world data repository and a multilevel biobank, locally stored and centrally annotated. This strategy seeks to lay the foundation for the clinical implementation of data-driven research, ultimately advancing precision oncology.

During the first months of 2020, the Covid-19 pandemic has affected several countries all over the world, including Italy. To prevent the spread of the virus, governments instructed employers and self-employed workers to close their offices and work from home. Thus, the use of remote working increased during the pandemic and is expected to maintain high levels of application even after the emergency. Despite its benefits for both organizations and workers, remote working entails negative consequences, such as technostress. The present study had a double aim: to test the psychometric characteristics of the Italian translation of the brief version of the technostress creators scale and to apply the scale to investigate technostress during the Covid-19 emergency. The research involved 878 participants for the first study and 749 participants for the second one; they completed a self-report online questionnaire. Results confirmed the three-factor structure of the Italian technostress creators scale and highlighted positive relationships between workload, techno-stressors, work–family conflict and behavioural stress. The role of remote working conditions has been analysed as well. The study provided a useful tool for the investigation of technostress in the Italian context. Moreover, it provided indications for practice in the field of remote working and workers’ wellbeing.

Background We developed a 13-mer locked nucleic acid (LNA) inhibitor of miR-221 (LNA-i-miR-221) with a full phosphorothioate (PS)-modified backbone. This agent downregulated miR-221, demonstrated anti-tumor activity against human xenografts in mice, and favorable toxicokinetics in rats and monkeys. Allometric interspecies scaling allowed us to define the first-in-class LNA-i-miR-221 safe starting dose for the clinical translation. Methods In this first-in-human, open-label, dose-escalation phase 1 trial, we enrolled progressive cancer patients (aged ≥ 18 years) with ECOG 0–2 into 5 cohorts. The treatment cycle was based on a 30-min IV infusion of LNA-i-miR-221 on 4 consecutive days. Three patients within the first cohort were treated with 2 cycles (8 infusions), while 14 patients were treated with a single course (4 infusions); all patients were evaluated for phase 1 primary endpoint. The study was approved by the Ethics Committee and Regulatory Authorities (EudraCT 2017-002615-33). Results Seventeen patients received the investigational treatment, and 16 were evaluable for response. LNA-i-miR-221 was well tolerated, with no grade 3–4 toxicity, and the MTD was not reached. We recorded stable disease (SD) in 8 (50.0%) patients and partial response (PR) in 1 (6.3%) colorectal cancer case (total SD + PR: 56.3%). Pharmacokinetics indicated non-linear drug concentration increase across the dose range. Pharmacodynamics demonstrated concentration-dependent downregulation of miR-221 and upregulation of its CDKN1B/p27 and PTEN canonical targets. Five mg/kg was defined as the recommended phase II dose. Conclusions The excellent safety profile, the promising bio-modulator, and the anti-tumor activity offer the rationale for further clinical investigation of LNA-i-miR-221 (ClinTrials.Gov: NCT04811898).

During the first months of 2020, the world, and Italy at an early stage, went through the COVID-19 emergency that had a great impact on individual and collective health, but also on working processes. The mandatory remote working and the constant use of technology for employees raised different implications related to technostress and psycho-physical disorders. This study aimed to detect, in such a period of crisis and changes, the role of organizational communication considering the mediating role of both technostress and self-efficacy, with psycho-physical disorders as outcome. The research involved 530 workers working from home. A Structural Equations Model was estimated, revealing that organizational communication is positively associated with self-efficacy and negatively with technostress and psycho-physical disorders. As mediators, technostress is positively associated with psycho-physical disorders, whereas self-efficacy is negatively associated. As regards mediated effects, results showed negative associations between organizational communication and psycho-physical disorders through both technostress and self-efficacy. This study highlighted the potential protective role of organizational communication that could buffer the effect of technostress and enhance a personal resource, self-efficacy, which is functional to the reduction of psycho-physical disorders. This study contributed to literature underlying the role of communication in the current crisis and consequent reorganization of the working processes.

Background: The introduction of immunotherapy has significantly improved survival outcomes in many solid tumors. However, a subset of patients exhibits limited responsiveness to immune checkpoint inhibitors (ICIs). Emerging evidence indicates that the gut microbiota plays a critical role in modulating the effectiveness of immunotherapy. Consequently, the concurrent use of certain medications that disrupt microbial diversity may contribute to reduced treatment efficacy. Among the agents implicated in altering the gut microbiota are antibiotics and proton pump inhibitors (PPIs). Methods: A systematic literature search was conducted in PubMed, Scopus, and EMBASE. Eligible studies assessed the association between PPI use and progression-free survival (PFS) and/or overall survival (OS) in patients with solid tumors receiving ICIs. They reported hazard ratios (HRs) with 95% confidence intervals (CIs). The analysis focused on studies published between November 2022 and January 2025, in continuity with prior comprehensive meta-analyses that included studies up to November 2022. This contiguity-based approach enabled a focused evaluation of recent evidence, minimizing redundancy while allowing for the detection of evolving trends in clinical practice and methodology. Data were synthesized using both fixed-effects and random-effects models and visualized via Forest plots. Study quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) and the Newcastle–Ottawa Scale (NOS). Between-study heterogeneity and publication bias were evaluated using I2 statistics and funnel plots. Results: From a pool of over 400 screened articles between November 2022 and January 2025, seven studies met the inclusion criteria. The PFS analysis incorporated data from 1367 participants, while the OS analysis included 10,420 individuals. Use of PPIs was linked to a 12% higher risk of disease progression (HR = 1.12; 95% CI: 0.90–1.34) and an 18% increased mortality risk (HR = 1.18; 95% CI: 1.11–1.25). Conclusions: The observed association between PPIs exposure and reduced efficacy of ICIs, as reflected in worsened PFS and OS outcomes, highlights a potential clinical concern that merits further investigation in prospective studies.