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Patients surviving head and neck cancer (HNC) suffer from high physical, psychological, and socioeconomic burdens. Achieving cancer-free survival with an optimal quality of life (QoL) is the primary goal for HNC patient management. So, maintaining lifelong surveillance is critical. An ambitious goal would be to carry this out through the advanced analysis of environmental, emotional, and behavioral data unobtrusively collected from mobile devices. The aim of this clinical trial is to reduce, with non-invasive tools (i.e., patients’ mobile devices), the proportion of HNC survivors (i.e., having completed their curative treatment from 3 months to 10 years) experiencing a clinically relevant reduction in QoL during follow-up. The Big Data for Quality of Life (BD4QoL) study is an international, multicenter, randomized (2:1), open-label trial. The primary endpoint is a clinically relevant global health-related EORTC QLQ-C30 QoL deterioration (decrease ≥10 points) at any point during 24 months post-treatment follow-up. The target sample size is 420 patients. Patients will be randomized to be followed up using the BD4QoL platform or per standard clinical practice. The BD4QoL platform includes a set of services to allow patients monitoring and empowerment through two main tools: a mobile application installed on participants’ smartphones, that includes a chatbot for e-coaching, and the Point of Care dashboard, to let the investigators manage patients data. In both arms, participants will be asked to complete QoL questionnaires at study entry and once every 6 months, and will undergo post-treatment follow up as per clinical practice. Patients randomized to the intervention arm (n=280) will receive access to the BD4QoL platform, those in the control arm (n=140) will not. Eligibility criteria include completing curative treatments for non-metastatic HNC and the use of an Android-based smartphone. Patients undergoing active treatments or with synchronous cancers are excluded.Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT05315570).

Abstract Background Psychological health has been one of the aspects affected by the recent COVID-19 pandemic. We aim to evaluate the patterns of Google search for mental distress symptoms of Italian citizens during the various phases of the COVID-19 pandemic. Methods We assessed Google searches for psychological-health related words. We gathered and analyzed data on daily search queries on depression, anxiety, and insomnia from Google Trends, in a time ranging from the Pre-COVID phase (beginning 25th January 2020) up to the second wave phase (ending 17th October 2020). We performed three general linear models on search trends of the three words and tested whether and to what extent official data about new cases of COVID-19, information searching on new cases, and the government health measures impacted on these trends. Results Average daily search queries were higher for anxiety, followed by depression and insomnia. General linear models performed to assess differences in daily search queries for anxiety, depression and insomnia were significant, respectively [F(13, 253) = 6.80, P

Prospective memory defines the ability to remember to perform an action related to a specific task planned for the future. Interventions aimed to improve prospective memory have an impact on the patient’s quality of life. While most interventions are aimed to improve prospective memory in general, implementation intentions influence specific automatic processes related to prospective memory. The efficacy of this type of intervention has been proven on different samples of patients as well as on lay people. We argue that, while in cancer patients who suffer from perspective memory deficit this particular intervention has not been studied yet, it could be usefully implemented to foster patients’ involvement, quality of life and adherence to care.

Objective: The study aimed to explore the psychological symptoms and the readiness to fight the pandemic of the new generation of healthcare professionals: medical and other healthcare degree students.Methods: We enrolled 509 medical and healthcare-related degree students during the second outbreak of COVID-19 in Italy. We have examined their psychological symptoms using the 12-item General Health Questionnaire (GHQ-12) and their readiness to fight the pandemic together with their academic career status, their relationship with the university, and their emotional reactions to the pandemic with Visual Analog Scales.Results: We retrieved a GHQ mean of 21.65 (SD = 40.63) and readiness to fight the pandemic mean of 53.58 (SD = 31.49). Perceived control affects variables: a negative effect on psychological symptoms and a positive effect on the willingness to fight the pandemic. The other variables with an impact were stress, loneliness, and anger that had a significant and positive impact on psychological symptoms. Age and concern for patients had a significant positive impact on readiness to fight for the pandemic, while years of attendance had a significant but negative impact.Conclusion: Universities and Institutions should consider the impact of the pandemic on students, in particular, for its effect on their mental health.

BackgroundThe COVID-19 pandemic is a traumatic individual and collective chronic experience, with tremendous consequences on mental and psychological health that can also be reflected in people’s use of words. Psycholinguistic analysis of tweets from Twitter allows obtaining information about people’s emotional expression, analytical thinking, and somatosensory processes, which are particularly important in traumatic events contexts. ObjectiveWe aimed to analyze the influence of official Italian COVID-19 daily data (new cases, deaths, and hospital discharges) and the phase of managing the pandemic on how people expressed emotions and their analytical thinking and somatosensory processes in Italian tweets written during the first phases of the COVID-19 pandemic in Italy. MethodsWe retrieved 1,697,490 Italian COVID-19–related tweets written from February 24, 2020 to June 14, 2020 and analyzed them using LIWC2015 to calculate 3 summary psycholinguistic variables: emotional tone, analytical thinking, and somatosensory processes. Official daily data about new COVID-19 cases, deaths, and hospital discharges were retrieved from the Italian Prime Minister's Office and Civil Protection Department GitHub page. We considered 3 phases of managing the COVID-19 pandemic in Italy. We performed 3 general models, 1 for each summary variable as the dependent variable and with daily data and phase of managing the pandemic as independent variables. ResultsGeneral linear models to assess differences in daily scores of emotional tone, analytical thinking, and somatosensory processes were significant (F6,104=21.53, P

This study aimed at exploring the emotional reaction that medical students (MS) and professionals have faced during the COVID-19 pandemic and investigating the differences between the two groups. A total of 362 MS and 330 professionals filled in an online survey during the second outbreak of the COVID-19 pandemic in Italy. The outcome measures were psychological distress with the General Health Questionnaire, stress, fear for themselves, fear for family members and cohabitants, perceived control, anger, loneliness, and feeling abandoned by institutions with Visual Analog Scales (VAS) and two open-ended questions about their perceived difficulties and the perceived consequences of the pandemic. The results showed that the level of distress among the two groups was above the threshold (MS mean: 21.85; professionals mean: 21.25). The means of the VAS of MS and professionals showed different results for the two groups, and we analyzed them with independent samples t-tests and linear regressions. MS reported higher levels of perceived loneliness (t(673.177) = −1.970, p < 0.05), while physicians reported more fear for themselves (t(655.183) = 4.799, p < 0.001), anger (t(690) = 2.096, p < 0.05), and feeling abandoned by the institutions (t(690) = 7.296, p < 0.001). The open questions were analyzed considering the most frequent words used to describe their perceived difficulties and consequences; the specificity analysis emphasizes the differences in the words used by the two groups. In conclusion, MS and physicians reported similar levels of psychological symptoms. Physicians were mostly worried about themselves, they were afraid of getting infected, while MS suffered from loneliness and the missed possibilities concerning their education.

ObjectiveThe study aimed to investigate the mental health and emotional reaction of physicians working during phase 1 of the COVID-19 pandemic in Italy.MethodsA total of 458 Italian Health Care Workers (HCWs) working during phases 1 of the COVID-19 outbreak were voluntarily enlisted in the study and recruited with the snowball technique through an online survey. We examined our variables with the General Health Questionnaire – 12 and with Visual Analog Scales.ResultsThe sample has a high level of psychological distress 21.26 (SD = 4.46), the emotional reaction was characterized by high level of fear for family members and cohabitants (M = 77.67, SD = 27.16) and patients (M = 67.16, SD = 27.71). Perceived control, fear for patients, and for family members and cohabitants, feeling alone and anger all contribute to a decreased mental health in Italian physicians (R2 = 0.285, p < 0.001).ConclusionItalian HCWs’ mental health and emotional reaction have to be considered to prevent high risk of burnout and post-traumatic stress disorder (PTSD). It becomes pivotal in the next months to implement a tailored psychological intervention to take care of HCWs and to prevent costly consequences for them, patients, and the healthcare system.

Aim of the study: Genetic testing is becoming increasingly common in clinical practice and health management; nonetheless, little is known about how the population approaches genetic services through private companies. Our study aims to describe socio-demographic aspects, health-related habits, and overall beliefs and knowledge about genetic risk and testing in a population of Italian citizens who decided to undergo a genetic examination through a private genetic company.Study design: A sample of 152 clients from an Italian private genetic company completed an ad-hoc survey from September 2016 to February 2018, addressing socio-demographic data, health habits, psycho-physic condition, perceived utility of genetic results, decision purposes about data sharing, and behavioral changes after results.Results: Participants (mean age 42.4) were predominantly female (82.2%) and were overall well-educated. Their main source of information were physicians (77%), and 41.1% entrusted the management of results to the same. Thirty-eight percentage underwent genetic analysis for cancer predisposition, 31.3% for fertility problems, 24% for dietary or intolerance issues in the period of enrolment. More than half of them (62.7%) reported a family history of the disease, and overall 69% had a current or past experience with a disease. Clients perceived the genetic screening as useful to adopt behaviors that may prevent disease onset (37.7%), to know their “real health status” (27.4%), and to adopt health-related behaviors (23.3%). 62.8% claimed they were motivated to change behaviors after results (healthier diet, practice exercise, medical checks), and they wanted to share results with their physician and family members.Discussion/Conclusion: The overview of consumers' profiles in Italy and other European countries can contribute to tailoring and regulating genetic services in a way that could be efficient in terms of healthy choices, behaviors, and health resource expenditures for the general public.

Objectives: To investigate stakeholder perspectives on how patient preference studies (PPS) should be designed and conducted to allow for inclusion of patient preferences in decision-making along the medical product life cycle (MPLC), and how patient preferences can be used in such decision-making.Methods: Two literature reviews and semi-structured interviews (n = 143) with healthcare stakeholders in Europe and the US were conducted; results of these informed the design of focus group guides. Eight focus groups were conducted with European patients, industry representatives and regulators, and with US regulators and European/Canadian health technology assessment (HTA) representatives. Focus groups were analyzed thematically using NVivo.Results: Stakeholder perspectives on how PPS should be designed and conducted were as follows: 1) study design should be informed by the research questions and patient population; 2) preferred treatment attributes and levels, as well as trade-offs among attributes and levels should be investigated; 3) the patient sample and method should match the MPLC phase; 4) different stakeholders should collaborate; and 5) results from PPS should be shared with relevant stakeholders. The value of patient preferences in decision-making was found to increase with the level of patient preference sensitivity of decisions on medical products. Stakeholders mentioned that patient preferences are hardly used in current decision-making. Potential applications for patient preferences across industry, regulatory and HTA processes were identified. Four applications seemed most promising for systematic integration of patient preferences: 1) benefit-risk assessment by industry and regulators at the marketing-authorization phase; 2) assessment of major contribution to patient care by European regulators; 3) cost-effectiveness analysis; and 4) multi criteria decision analysis in HTA.Conclusions: The value of patient preferences for decision-making depends on the level of collaboration across stakeholders; the match between the research question, MPLC phase, sample, and preference method used in PPS; and the sensitivity of the decision regarding a medical product to patient preferences. Promising applications for patient preferences should be further explored with stakeholders to optimize their inclusion in decision-making.