Incidence of PTSD and generalized anxiety symptoms during the first wave of COVID-19 outbreak: an exploratory study of a large sample of the Italian population.

BACKGROUND: During the COVID-19 pandemic, between March and May 2020, in Italy, people were asked to shelter in place and most had to put their life on hold, while news of the spread of the virus constantly were broadcasted. The change in habits and the potential exposure to a dangerous virus can be categorized as a catastrophic event, which are usually traumatic and therefore have psychological consequences for the people involved. OBJECTIVE: Assuming the COVID-19 pandemic as a possible traumatic event, this study aims to explore the contingent behavioural and psychological impact of COVID-19 spread and related lockdown on the Italian general population, through measuring anxiety and post-traumatic stress symptoms . METHODS: An ad hoc-survey was set up for the this exploratory research, including the standardized Italian versions of the Impact of Event Scale Revised (IES-R) and the Generalized Anxiety Scale (GAD-7), and ad hoc items concerning behavioural reactions due to the pandemic spread and related mass quarantine. Participants were recruited across convenient web-based and mobile app channels using a snowball sampling technique. Data was collected from March 25th to May 1st, 2020. PARTICIPANTS: One-thousand one hundred and ninety-five individuals (851 women and 342 men) completed 60% or more of the survey and were considered for analyses. Mean age was 40 years (s.d. = 14.948). Participants resided in 78 Italian provinces (out of 107 territorial divisions), with 25.7% residing in the Milan province and 9.2% from the Monza and Brianza provinces, closest to the epicentre of the Italian outbreak. RESULTS: During the worst months of the first wave of the Pandemic, the Italian population suffered high level of distress (GAD-7 m = 6.89, s.d. = 5.08; IER-R mean score = 27.86, s.d. 17.46), respectively indicating mild presence of anxiety symptoms, and high levels of PTSD symptoms. Gender seems to be a discriminating variable with women scoring significantly higher than man, both for anxiety symptoms (H (1) = 82.91, p < .001) and all dimensions of PTSD symptoms (intrusion H (1) = 71.23, p < .001, avoidance H (1) = 61.28, p < .001), and hyperarousal (H (1) = 67.348, p < .001). People from Generations Y and Z show to be at higher risk of developing PTSD (V = .746, F (3,1041) =1017.19, p = .001) and GAD symptoms (F (3,1041) = 5.113, p = .002) than older generations. CONCLUSIONS: Gender and generation appeared to be the most consistent risk factor for higher levels of generalized anxiety and PTSD symptoms in the current pandemic. Other variables - such as information seeking behaviours, parental and marriage status, chronic conditions - yielded less consistent evidence. Results indicate the need of including psychological interventions as a standard tool during the emergency management of a catastrophic events such as a pandemic.

"Just" blood donors? A study on the multi-affiliations of blood donors.

BACKGROUND: The present work proposes to explore a phenomenon well known in the world of blood donation, but little explored by literature: multi-affiliations. By that term, in this paper we mean blood donors' engagement in multiple associations of various natures (donation, recreation, sports, etc.) simultaneously. The first objective proposes to explore the phenomenon of multi-affiliations in descriptive terms; the second is to look into the differences-in terms of motivations, family-work-volunteerism reconciliation, life satisfaction, and membership satisfaction-between those who "only" carry out blood donation activity and those who instead participate in multiple associative realities concurrently. METHOD: Participating in the research were 2674 donors from the Italian Association of Blood Donors (AVIS) (age range 18-65; 66.6% male) to which a self-report questionnaire was administered in the waiting rooms of numerous blood donation centers. RESULTS: Regarding the first objective, it emerged that only 35.9% of the participants "only" donate blood, while a good 64.1% is engaged also in other associations. Regarding the second objective, statistically significant differences emerge regarding many of the variables considered: social, values, ego-protection, and career motivation; capacity to reconcile family-volunteering and work-volunteering; life satisfaction; and membership satisfaction. CONCLUSIONS: The study offers precious information to the agencies that handle recruiting and retaining of donors. The agencies in fact can take away information on how to improve the multi-affiliations of their donors, an aspect that can facilitate their long-term retention.

Economic crisis and blood donation: How are donors' motivations changing?

BACKGROUND: The economic crisis has exasperated people's feelings of loneliness; job instability often does not allow people to commit to voluntary work. The present work proposes to examine whether the motivations to donate blood have changed before and during the period of economic crisis, taking into consideration donors' gender. We adopted Omoto & Snyder's functionalist approach, which states that blood donation serves different functions for any one person, who may have different motivations from those held by other people. MATERIALS AND METHODS: We compared six-year pre-post (t1 "pre-crisis": 2008 - t2 "during the crisis": 2014) data on a sample of blood donors in a single blood donation center situated in Northern Italy. T-test was used for data analysis. Three hundred thirty donors (age range 18-60, M = 32.6, SD = 9.53; 54.5% male) were administered a survey at t1 and 444 (age range 18-60, M = 37.8, SD = 10.16; 68% male) six years later at t2. In both surveys, participants were administered a questionnaire with socio-demographic items and a version of Omoto & Snyder's Motivations to Volunteer scale adapted to blood donation. RESULTS: Donors' motivation priorities did not vary over time. Values and Self-enhancement motivations are the most prevalent. Knowledge and Ego-protection motivations decreased with the upsurge of the crisis. Women, in general, report higher mean values than men do for Values and Ego-protection motivations. CONCLUSION: These results can offer valuable clues for the agencies that manage blood collection.

New donors, loyal donors, and regular donors: Which motivations sustain blood donation?

BACKGROUND: The present contribution aims to investigate the motivations underlying blood donation and to probe how these differ on the basis of number of donations and donors' gender. MATERIALS AND METHODS: A total of 237 Italian donors (64.6% male) were administered a self-report questionnaire containing socio-demographic variables and Omoto and Snyder's Motivations for Volunteerism Scale adapted to blood donation. RESULTS AND DISCUSSION: The results reveal: (a) significant differences between new donors (1-4 donations) and loyal donors (5-15 donations) as well as between new donors and regular donors (more than 16 donations) emerge with respect to social motivations and ego-protection, which increase proportionately to number of donations; (b) gender differences characterize all the motivations except those related to values; (c) value motivations do not vary either with respect to number of donations or to gender.

Toward a new personalized psycho-social approach for the support of prostate cancer and their caregivers dyads: a pilot study.

Introduction: Prostate cancer patients (PCP) often struggle with a significant emotional, physical, and social burden during the care-flow pathway. Noteworthy, PCP should not be considered a standalone patient, but someone who is connected with a relevant social environment and that is usually supported by a beloved one, the caregiver. The involvement of the caregivers through the care pathway might bring significant benefits both on the psychological and the treatment and decision-making side. The present pilot study aimed at preliminarily assessing quantitatively the psychological impact of a prostate cancer diagnosis on the degree of agreement of PCPs and their caregivers on medical decisions, coping resources and psychological distress levels. Methods: 16 PCP and their caregivers were enrolled in the study and fulfilled a battery of standardized questionnaires. Results: Results showed low concordance in decision making styles and preferences in patients and their caregivers and that the dyads showed similar depression symptoms levels. Relevant features of the psychological needs of the analyzed dyads, such as need for information and support, also emerged. Conclusion: On the basis of these preliminary results, guidelines for the construction of tailored brief psychological support interventions for PCP dyads are provided.

The heart-mind relationship in women cardiovascular primary prevention: the role of depression, anxiety, distress and Type-D personality in the 10-years cardiovascular risk evaluation.

Introduction: Cardiovascular diseases are the leading cause of death among women. Prevention programmes underscore the need to address women-specific risk factors. Additionally, mental well-being is a significant aspect to consider when grappling with cardiovascular disease in women, particularly depression, anxiety, distress, and personality traits. This study aimed to create "at-risk" psychological profiles for women without prior cardiovascular disease history and to evaluate the association between anxiety, depression, distress, and Type-D personality traits with increased cardiovascular risk over 10 years. Methods: 219 women voluntarily participated in the "Monzino Women's Heart Centre" project for primary prevention and early diagnosis of cardiovascular diseases. Psychological profiles were developed utilising cluster analysis. Results: The primary finding indicating that belonging to the "at-risk" psychological cluster was associated with a surge in the 10-year cardiovascular risk prediction score, despite the number of comorbid risk factors (Psychological "at-risk" cluster: ß = .0674; p = .006; Risk factors: ß = .0199; p = .242). Conclusions: This finding suggests that psychological well-being of women should be assessed from the very beginning of cardiovascular prevention programmes.

How Much Stress Does a Surgeon Endure? The Effects of the Robotic Approach on the Autonomic Nervous System of a Surgeon in the Modern Era of Thoracic Surgery.

(1) Objective: the purpose of this study was to evaluate and quantify the stress to which a surgeon is subjected during his/her surgical activity; we compared the individual clinical and psychological responses to stress of two surgeons during their surgical activities via robotic and open approaches. (2) Materials and methods: This was a prospective observational study in which we progressively collected data concerning the surgical performances of two different thoracic surgeons (October 2021-June 2022). We evaluated 20 lung resections performed via robot-assisted surgery and 20 lung resections performed via an open approach by each surgeon; in particular, we evaluated a panel of pre-, peri-, and postoperative data concerning the interventions, the patients, and other outcomes concerning the autonomic nervous system (ANS) and psychological responses to stress of the surgeons during their surgical activities. (3) Results: When analyzing data concerning the ANS activity of two surgeons, during robotic activity we found lower maximum, minimum, and mean heart rates; lower mean respiratory frequencies; lower body temperatures; and lower mean desaturations compared to the open approach activity for both surgeons. The psychological monitoring showed that the open approach created more physical fatigue and frustration but higher levels of satisfaction and performance evaluation. The robot-assisted surgeries showed higher levels of anxiety. (4) Conclusions: for different reasons, the robotic approach stimulated the ANS to a lesser degree, causing less stress for surgeons and ensuring greater comfort.

The Burden of the Pain: Adverse Mental Health Outcomes of COVID-19 in Women With and Without Cancer.

The coronavirus disease 2019 (COVID-19) pandemic had a negative psychological impact on the population at scale, yet it is possible that vulnerable patient populations may experience a heavier burden with increased feelings of anxiety and distress. Cancer patients have to trade-off between the fear of exposing themselves to the virus and the need to continue life-saving medical procedures. The present study investigated the prevalence of generalized anxiety and post-traumatic stress symptoms (PTSS) in a population of Italian cancer patients and healthy participants in the months following the COVID-19 outbreak. Using standardized measures of PTSS (impact of event scale revised; IES-R) and generalized anxiety (generalized anxiety scale; GAD-7), we found that patients experienced higher levels of adverse mental health outcomes. Several variables were found to negatively affect PTSS and anxiety in this population, including the younger age of respondents, having children, and the impossibility to attend regular medical check-ups. These findings stress the importance of maintaining a clear and regular communication with patients throughout future waves of the pandemic and ensure continuity of care in this vulnerable population. Furthermore, this study indicates the need to establish psychological interventions aimed at patients with cancer, targeting especially younger generations who are more likely to experience adverse psychological outcomes.

The Motivation Journey: A Grounded Theory Study on Female Cancer Survivors' Experience of a Psychological Intervention for Quality of Life.

Psychological interventions are proposed to cancer survivors to support their quality of life against the emotional trauma of cancer and the side effects of treatment. Psychological interventions often require patient engagement and commitment to activities that could be more or less demanding in terms of lifestyle change (e.g., psychotherapy, sports). Analyzing participant motivations (personal aims, expectations, needs) prior to participation is useful to predict their adherence to the intervention as well as final outcomes. Yet, participant motivations may evolve during the intervention because the intervention experience turns out to be meaningful and positively challenging. The present study aimed to obtain a preliminary understanding of the process of motivation change in female cancer survivors who participated in a sport-based intervention to promote quality of life by employing a grounded theory approach. Data analysis took place alongside data collection and according to the procedure of grounded theory ("open coding", "axial coding", and "selective coding") in order to describe the process of motivation change during women's participation in psychological intervention for quality of life. On 14 women interviewed, 13 reported changing their motivation to participate during the first months of involvement, mostly changing from individualistic to group-related motivations (i.e., from self-care to friendship with other participants and enriching group membership), and from physical to psychological growth (i.e., pursuing not only physical health but also self-fulfillment). The discussion explains the preliminary aspects of the motivation change process and highlights the importance to monitor motivation dynamics within psychological interventions.

Psychological Benefits of a Sport-Based Program for Female Cancer Survivors: The Role of Social Connections.

In the context of sports-based interventions for improving health and quality of life in chronic patients, participants could develop meaningful social relationships that affect their well-being as much as intervention activities. In this study, 80 female cancer survivors participated in a running-based group intervention (2 sessions/week; 1.5 h), while 51 acted as controls. The intervention lasted approximately 5 months. Unfortunately, the length of the intervention was reduced and sport activities were altered by the COVID-19 pandemic and lockdown mid-intervention, while the shared therapy sessions continued online. This possibly altered the results, as anxiety, depression, and physical aspects did not show significant differences between the experimental and control groups after the intervention. Participants reported positive comments on the experience as a whole, especially regarding the positive influence of the newly developed social connections. This was corroborated by significant correlations between group perceived cohesion and anxiety, depression, self-efficacy, and positive experience with the group psychological support. Overall, it is possible to suggest that in the program an important role was played by social connections and support, peer influence and the group experience, preserving positive experiential qualities of the intervention even if it was altered by external circumstances.

Coping With Oral Tongue Cancer and COVID-19 Infection.

To date, April 19, 2021, the coronavirus disease 2019 (COVID-19) caused about 140,886,773 confirmed cases and more than 3,000,000 deaths worldwide since the beginning of the pandemic. Oncology patients are usually frail due to the fear of prognosis, recurrence, and outcomes of treatments. Thus, coping with cancer is a complicated process that is necessary to overcome oncological challenge, even more in case of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) disease. This is a brief case report on a middle-aged man affected by advanced oral tongue cancer and COVID-19, describing his experience of cancer diagnosis, surgical treatment, and rehabilitation during the hospital quarantine for COVID-19. Besides the traumatic experience due to the functional alteration in breathing, eating, and speaking caused by major surgery and the concurrent facial disfigurement, our patient had to face a COVID-19 diagnosis, which implied hospital and social isolation. The aim of this perspective work is to focus on the role of the psychological support in the management of hospital distress related to COVID-19 psychophysical loneliness or alienation. In our experience, such support should anticipate patients' oncological surgery or treatment and should be implemented through telemedicine in case of isolation or after hospital discharge.

Quality of life and psycho-emotional wellbeing in bladder cancer patients and their caregivers: a comparative analysis between urostomy versus ileal orthotopic neobladder.

BACKGROUND: The impact of neobladder and urostomy on bladder cancer patient's health-related quality of life (HR-QoL) is controversial and many issues currently remain under-investigated. Initial studies pointed out that the emotional responses of caregivers might be 'contagious', influencing emotional reactions in bladder cancer patients undergoing radical cystectomy. METHODS: Three hundred and eighty-two bladder cancer patients (aged M = 67.29 years; SD = 9.23) (16.9% (65) were female and 82.9% (319) were male) and their caregivers were enrolled. Data were collected prospectively: at T0 (1 month before the surgery), at T1 (2 weeks after the surgery, at patient discharge from the hospital) and at T2 (6-month follow-up). At each time point (T0, T1 and T2), a set of questionnaires (EORT QLQ-C30 and emotion thermometer) were given to patients and their caregivers. RESULTS: All patients reported a general improvement in the HR-QoL and global health status/QoL from T0 to T2 (p < 0.001). No significant differences were observed between neobladder and urostomy. At T0, the emotional thermometer total scoring in caregivers was positive in relation to HR-QoL (p < 0.001) and negative in relation to the patient's perception of QoL (p < 0.001) and global health (p < 0.001). Similar trends were observed at T1 and T2. CONCLUSIONS: These results suggest that patients and their caregiver's emotional reactions to cancer are deep-rooted and strongly interconnected, and they provide innovative insights for the clinical management of bladder cancer patients.

What Matters Most to Lung Cancer Patients? A Qualitative Study in Italy and Belgium to Investigate Patient Preferences.

Background: The potential value of patient preference studies has been recognized in clinical individual treatment decision-making between clinicians and patients, as well as in upstream drug decision-making. Drug developers, regulators, reimbursement and Health Technology Assessment (HTA) bodies are exploring how the use of patient preference studies could inform drug development, regulatory benefit risk-assessment and reimbursement decisions respectively. Understanding patient preferences may be especially valuable in decisions regarding Non-Small Cell Lung Cancer (NSCLC) treatment options, where a variety of treatment options with different characteristics raise uncertainty about which features are most important to NSCLC patients. As part of the Innovative Medicines Initiative PREFER project, this qualitative study aimed to identify patient-relevant lung cancer treatment characteristics. Methods: This study consisted of a scoping literature review and four focus group discussions, 2 in Italy and 2 in Belgium, with a total of 24 NSCLC patients (Stages III-IV). The focus group discussions sought to identify which treatment characteristics patients find most relevant. The discussions were analyzed thematically using a thematic inductive analysis. Results: Patients highlighted themes reflecting: 1) positive effects or expected gains from treatment such as greater life expectancy and maintenance of daily functioning, 2) negative effects or adverse events related to therapy that negatively impact patients' daily functioning such as fatigue and 3) uncertainty regarding the duration and type of treatment effects. These overarching themes were consistent among patients from Belgium and Italy, suggesting that treatment aspects related to efficacy and safety as well as the psychological impact of lung cancer treatment are common areas of concern for patients, regardless of cultural background or country. Discussion: Our findings illustrate the value of using qualitative methods with patients to identify preferred treatment characteristics for advanced lung cancer. These could inform a subsequent quantitative preference survey that assesses patient trade-offs regarding treatment options.

Exploring public attitude toward biofeedback technologies: Knowledge, preferences and personality tendencies.

Background: Biofeedback is increasingly used in the clinical area and in daily health monitoring through wearable devices (e.g. smart watches). Nevertheless, it remains rather unknown. This study aimed to assess, in a sample of Italian citizens, the level of knowledge, attitudes, perceived efficacy and personality tendencies which could affect the uptake of biofeedback technologies. Design and Methods: Participants were recruited by advertising the survey on the social networks, from March to May 2019. 160 subjects filled in an ad hoc online questionnaire assessing socio-demographic variables, clinical status, physical activity, knowledge and attitude towards biofeedback, psychological tendencies toward health. Results: Data showed a good level of interest in biofeedback training in spite of poor knowledge about such technologies. Sport and chronic diseases were not correlated to a greater use of biofeedback. People informed about biofeedback technologies were more interested in undergoing biofeedback training and had higher scores in the Health Locus of Control. Finally, people who showed a positive perception of their own health (Health Esteem) did not rely on these technologies. Discussion: Despite the huge spread of biofeedback technologies, our results disconfirmed the expectation that people having an active lifestyle or a disease were more familiar with biofeedback systems. The attitude toward such technologies seems to depend on individual tendencies. Conclusions: This study suggests the importance to improve general public literacy on biofeedback technologies, tailor tools on their needs and characteristics, empower people's sense of internal health control for promoting a valid use and a proper knowledge of biofeedback.

Patients Living With Breast Cancer During the Coronavirus Pandemic: The Role of Family Resilience, Coping Flexibility, and Locus of Control on Affective Responses.

The coronavirus disease 2019 (COVID-19) pandemic has strongly affected oncology patients. Many screening and treatment programs have been postponed or canceled, and such patients also experience fear of increased risk of exposure to the virus. In many cases, locus of control, coping flexibility, and perception of a supportive environment, specifically family resilience, can allow for positive emotional outcomes for individuals managing complex health conditions like cancer. This study aims to determine if family resilience, coping flexibility, and locus of control can mitigate the negative affect caused by the pandemic and enhance positive affect in breast cancer patients. One hundred and fifty-four female patients with breast cancer completed the Walsh's Family Resilience Questionnaire, the Perceived Ability to Cope With Trauma Scale, the Positive-Negative Affect Schedule, and the Mini Locus of Control Scale. Family resilience and internality of locus of control contribute significantly to positive affective responses. Family resilience is responsible for mitigating the negative affect perceived during the pandemic and is enhanced by external locus of control. Evidence suggests that clinical psychologists should develop and propose programs to support oncology patients' family resilience, coping flexibility, and internal locus of control, allowing for decreased stress and improved adaptability for effectively managing cancer treatment during the pandemic.

The clinical-care focused psychological interview (CLiC): a structured tool for the assessment of cancer patients' needs.

Integrating the psychosocial perspective in oncology is warranted. Here, we introduce a structured psychological intervention, the clinical-care focused psychological interview (CLiC), to address patients' needs in the relationship with health professionals, clinical pathway and decision-making process. The perceived utility and feasibility of the CLiC were evaluated in a preliminary sample of 30 patients who were candidates to undergo a radical cystectomy at the European Institute of Oncology, Milan, Italy. Patients reported a very high satisfaction with the interview, because it prepared them for their upcoming surgery by gathering more information about their clinical pathway and allowed them to discover the information they still needed. 30% stated that CLiC helped them to reorganise their thoughts and 36.7% understood the role of psychological intervention in the clinical pathway. Only 20% considered the CLiC useful in helping to build their relationship with the clinical staff. Before an invasive surgery such as radical cystectomy, patients' need for information regarding the upcoming surgery seems to prevail. Knowing the future consequences and adjusting toward the disease could be paramount for patients in facing uncertainty and they might feel that creating a relationship with physicians could be a secondary issue. However, our data show that a structured psychological intervention such as the CLiC interview can collect important information for patients and healthcare professionals to develop real patient-centred care.

The patient perspective: investigating patient empowerment enablers and barriers within the oncological care process.

Patient empowerment is a multi-factorial concept and its relevance has led to a growing body of literature; despite this attention, there is still no agreement regarding the elements that define its expression. While several studies have already investigated the positive effect of empowerment interventions on the care process outcome, the aim of this study is to investigate which factors can foster an empowered management of the cancer condition from the patient's perspective. To examine patients' perception of empowerment enablers, we asked for participants' input on the role of three factors frequently cited as positively affected by empowerment: care quality, perception of direct control and relationships within the care context, during the care process. Three focus groups were conducted with 34 cancer patients. The results highlight the perception of direct control on their treatment as the least valued element (2.87, SD 0.566) when compared with care quality (3.75, SD 0.649) and relational support in the care context (3.91, SD 0.274). Unlike traditional approaches to empowerment, patient's expression of empowerment does not mainly reside in the direct control of their condition as much as in an active role within the relationship with caretakers, such as the ability to choose the doctor, the care team or the health organisation in charge of their healthcare. Emerging aspects from this analysis of patient's perspective are central in order to adequately consider empowerment in the care process and to provide more effective care strategies.

Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study.

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.