Psychometric Properties of the Italian Version of the Short-Form Supportive Care Needs Survey Questionnaire (SCNS-SF34-It): A Multicenter Validation Study.

This study aimed to evaluate psychometric properties of the Italian version of the Short-Form Supportive Care Needs Survey Questionnaire (SCNS-SF34) in a cancer population. A multicenter prospective observational study was carried out in outpatient and inpatient settings. The evaluated psychometric properties were as follows: the five-domain structure, the internal consistency, the convergent validity with the Edmond Symptom Assessment System (ESAS) questionnaire, the discriminant validity and test-retest reliability. A total of 714 patients with different types, stages and treatment settings of cancer were recruited. A total of 56% of participants were women, the median age 59 years (range 18-88). The prevalence of patients reporting at least one unmet need was 78.7%. The factor analysis explained 71.3% of the total variance, confirming the five-domain structure of the original model. Internal consistency was good, with Cronbach's alpha values ranging from 0.87 ("psychosocial need", "patient support and health system", "information") to 0.90 ("sexuality"). The convergent validity of the SCNS-SF34-It with the ESAS scale was low, suggesting that these questionnaires cover different concepts. The SCNS-SF34-It was able to discriminate differences between groups, and the test-retest reliability was good (ICC 0.72-0.84). The SCNS-SF34-It proved to be a reliable instrument for use in clinical practice for evaluating unmet needs in the Italian population of cancer patients. This study was not registered.

A Critical Overview of the Construct of Supportive Care Need in the Cancer Literature: Definitions, Measures, Interventions and Future Directions for Research.

The growing amount of evidence about the role of supportive care in enhancing cancer patients' outcomes has made healthcare providers more sensitive to the need for support that they experience during cancer's trajectory. However, the lack of a consensus in the definition of supportive care and lack of uniformity in the theoretical paradigm and measurement tools for unmet needs does not allow for defined guidelines for evidence-based best practices that are universally accepted. Contemporary cancer literature confirms that patients continue to report high levels of unmet supportive care needs and documents the low effectiveness of most of the interventions proposed to date. The aim of this critical review is to consolidate the conceptual understanding of the need for supportive care, providing definitions, areas of expertise and a careful overview of the measurement tools and intervention proposals developed to date. The possible reasons why the currently developed interventions do not seem to be able to meet the needs, and the issues for future research were discussed.

Long-term psychological outcome of patients with moderate-to-severe atopic dermatitis continuously treated with Dupilumab: Data up to 3 years.

Dupilumab effectiveness and safety in treating moderate-to-severe atopic dermatitis (AD) have been demonstrated in open-label studies up to 4 years. Evidence about long-term psychological outcome is lacking. This study evaluates the long-term psychological outcome of moderate-to-severe AD patients continuously treated with Dupilumab up to 3 years. A prospective observational real-life study was conducted at an Italian tertiary centre from January 2019 to September 2022. Measures of disease severity and psychological outcomes were assessed at baseline, after 4, 8, 12, 24 and 36 months. A total of 382 moderate-to-severe AD patients were included. After 36 months, EASI-75 and EASI-90 were achieved by 91.8% and 77.2% of participants. Significant improvement (p < 0.001; ω2  = 0.18-0.84) in objective and patient-reported measures of disease severity and in the psychological condition were observed after 4 months of treatment and maintained up to 36 months. Longitudinal analysis of interactions of demographic and clinical features found subgroups of patients who did not reported psychological improvement over the study period notwithstanding the positive clinical response. Long-term improvement in the psychological outcome of moderate-to-severe AD patients continuously treated with Dupilumab is confirmed up to 3 years, supporting its wide use in this population. Between-subject differences in the psychological outcome irrespective of clinical response observed in this study foster the biopsychosocial approach in the clinical management of these patients.

Preclinical and Clinical Medical Student Attitudes Toward the Care of the Dying: Testing the 9-Item Version of the Frommelt Attitude Toward the Care of the Dying Scale.

The demand for palliative care is increasing worldwide. Beyond the acquisition of technical knowledge, the development of adequate personal disposition toward the relationship with the dying is a key aspect of the future training of doctors. This study evaluates the psychometric properties of the 9-Item Version of the Frommelt Attitude Toward the Care of the Dying Scale (FATCOD-9IT) the authors recently developed and its capability to distinguish medical students with different attitudes toward the care of the dying and at different stages of medical training. The study included 595 medical students, 400 at the first and 195 at the fifth year. The Rasch rating scale model was specified to assess scale dimensionality, functioning and measurement invariance. Internal consistency, test-retest reliability and between-group difference sensitivity (first-vs fifth-year students) were evaluated using Cronbach's alpha, Intraclass correlation coefficients, Paired sample t-test and Mann-Whitney U. Scale unidimensionality, rating scale functioning and measurement invariance were established. The scale demonstrated good internal consistency and test-retest reliability, and adequately discriminated between first- and fifth-year students. The study supports the validity and reliability of the FATCOD-9IT. Its effectiveness, simplicity of compilation and score calculation, and gratuitousness encourage its widespread use as fast assessment of the medical student attitudes toward the care of the dying.

Demoralization during the Italian quarantine due to 2019 coronavirus disease pandemic: prevalence and association with psychological well-being and coping strategies.

The aims of the study were to investigate demoralization in a sample of Italian citizens during the Italian quarantine due to COVID-19 pandemic and to explore its associations with psychological well-being, coping strategies, participants' socio-demographic characteristics and COVID-19-related factors. Italian citizens aged over 18 and quarantined in Italy were recruited. A cross-sectional online survey was launched through a snow-ball sampling and 1123 surveys were collected. Participants answered ad hoc questions and completed the Psychological General Well-Being Index, the Demoralization Scale, and the Coping Orientation to Problems Experienced-New Italian Version. Disheartenment, dysphoria, and sense of failure were the subdimensions of demoralization with higher scores. Demoralization was associated with depressed mood, positive well-being, self-control, general health, vitality, problem-solving, and avoidance and religious coping strategies. Individuals who were female, older, without children and not working during quarantine had higher demoralization. Quarantine-related changes can elicit demoralization that is associated to lower psychological well-being. Problem-solving and religious coping can protect against demoralization, while avoidant coping strategies can exacerbate it. Assessing and treating demoralization, especially in the categories of citizens most at risk of developing it, could be useful to provide adequate care against COVID-19-related distress.

The Italian validation of the Death and Dying Distress Scale.

OBJECTIVES: Death anxiety (DA), a condition characterized by fear, angst, or panic related to the awareness of one's own death, is commonly observed in advanced cancer patients. The aim of this study was to examine the psychometric properties of the Italian version of the Death and Dying Distress Scale (DADDS-IT) in a sample of patients with advanced cancer. METHODS: The sample included 200 Italian advanced cancer patients meeting eligibility criteria to access palliative care. Patients' levels of DA were assessed by using the DADDS-IT, while the levels of depression, anxiety, demoralization, spiritual well-being, and symptom burden were assessed using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, the Demoralization Scale, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, and the Edmonton Symptom Assessment System, respectively; Karnofsky Performance Status was used to measure functional impairment. Confirmatory factor analyses (CFA) of previous structures and exploratory factor analyses (EFA) were conducted. RESULTS: CFA revealed that none of the previous structures adequately fitted data from our sample. EFA revealed a 4-factor model comprising Finitude (α = 0.91), Regret (α = 0.86), Dying (α = 0.88), and Relational Burden (α = 0.73), accounting for the 77.1% of the variance. Dying subscore was higher in hospice patients than in those recruited in medical wards. SIGNIFICANCE OF RESULTS: The present study provides further evidence that DA is a condition that deserves attention and that DADDS-IT shows good psychometric properties to support its use in research and clinical settings.

Impact on health-related quality of life and symptoms of anxiety and depression after 32 weeks of Dupilumab treatment for moderate-to-severe atopic dermatitis.

Dupilumab is the first biological agent approved for treatment of moderate-to-severe atopic dermatitis (AD). Evidence of Dupilumab effectiveness on psychological outcomes beyond 16 weeks of treatment from real-life settings is lacking. To evaluate the effectiveness of Dupilumab treatment up to 32 weeks, focusing health-related quality of life and psychological outcome of patients with moderate-to-severe AD. An observational prospective cohort study was conducted in a real-life setting at an Italian tertiary centre. Assessment of outcome measures was carried out at baseline, after 16 and 32 weeks of treatment. A total of 171 patients were included. EASI-75 and EASI-90 were achieved in 85% and 60% of the participants, respectively, after 16 weeks, and in 89.6% and 69.8% after 32 weeks of treatment. Significant improvements (p < 0.001; r = 0.57-0.95) were found after 16 weeks for each outcome considered, including clinician and patient-reported measures of AD severity and scales of health-related quality of life and psychological morbidity, and maintained up to 32 weeks. Further analysis revealed that patients' quality of life was more associated with the subjective perception of disease severity rather than objective measures and suggested a possible different response to treatment based on the age of AD onset. Dupilumab was confirmed to be rapid, effective and safe in patients with moderate-to-severe AD. Its positive impact on psychological outcomes up to 32 weeks was ascertained here, adding new evidence on the need to consider subjective factors affecting patients' perception of disease severity in evaluating the response to treatment.

Supportive Care Needs and the Impact of Loss of Functioning and Symptom Burden on the Quality of Life in Patients with Advanced Colorectal Cancer.

BACKGROUND/AIMS: Relationships between loss of functioning, symptom burden, supportive care needs, and quality of life (QoL) have been suggested in cancer populations. This cross-sectional study further investigates these relationships through mediation analyses. METHODS: A total of 276 advanced colorectal cancer (CRC) patients completed validated instruments to assess cancer-related functioning, symptoms, supportive care needs, and QoL. Pearson's correlations and multiple mediation models with bootstrapping method were performed. RESULTS: QoL had negative correlations with supportive care needs, positive correlations with functioning measures, and negative correlations with symptom scales. Supportive care needs had negative correlations with functioning measures and positive correlations with symptom scales. Mediation analyses showed significant indirect effects of CRC-related functioning and symptoms on QoL through supportive care needs. CONCLUSIONS: Significant links between CRC-related loss of functioning, symptom burden, QoL, and supportive care needs have been established. Longitudinal studies are planned to clarify cause-and-effects relationships and establish sequences of events.

Empathy for patient care in medical students: new evidence on the importance of self-transcendence.

Empathy is essential in clinical care to achieve patient satisfaction, treatment adherence and health outcomes. Understanding how personality traits might influence the development of medical students' empathy for patient care is important in medical education. Previous studies have shown associations between medical students' personality and empathy. This study aims to explore the associations between temperament and character and empathy for patient care in a sample of young medical students. Participants were 299 second-year Italian medical students. They completed the Italian versions of the Jefferson Scale of Empathy for medical students (JSE-S) and the Temperament and Character Inventory (TCI-140). Correlation and regression analyses were performed. Significant positive low correlations were found between empathy and Reward Dependence, Cooperativeness and Self-transcendence. The regression model of the sex and personality dimensions explained 14% of the variance in empathy with two significant predictors: sex (B = 4.034) and Self-transcendence (B = 0.361). This study confirms that female medical students are more empathetic than males. It also suggests that the greater students' Self-transcendence is, the more empathetic towards patient care they are. Attention to medical students' personality should be present within medical curricula, as it may help to generate methods of enhancing and sustaining the empathy of students.

Shortening the Frommelt Attitude Toward the Care Of the Dying Scale (FATCOD-B): a Brief 9-Item Version for Medical Education and Practice.

End-of-life care training has gaps in helping students to develop attitudes toward caring for the dying. Valid and reliable assessment tools are essential in building effective educational programmes. The Frommelt Attitude Toward the Care Of the Dying scale (FATCOD-B) is widely used to measure the level of comfort/discomfort in caring for the dying and to test the effectiveness of end-of-life care training. However, its psychometric properties have been questioned and different proposals for refinement and shortening have been put forward. The aim of this study is to get to a definitive reduction of the FATCOD-B through a valid and parsimonious synthesis of the previous attempts at scale revision. Data were gathered from a sample of 220 medical students. The item response theory approach was used in this study. Of the 14 items selected from two previous proposals for scale revision, 3 had a weak correlation with the whole scale and were deleted. The resulting 11-item version had good fit indices and withstood a more general and parsimonious specification (rating scale model). This solution was further shortened to 9 items by deleting 2 of 3 items at the same level of difficulty. The final 9-item version was invariant for gender, level of religiosity and amount of experience with dying persons, free from redundant items and able to scale and discriminate the respondents.

Emotional distress and psychiatric drug use among students in an Italian medical school: Assessing the role of gender and year of study.

BACKGROUND: Previous studies have reported that medical students show high rates of depression, anxiety, and stress levels, but mixed findings were found regarding possible differences between gender and different years of medical training. This study evaluated depression, anxiety, and stress levels and psychiatric drug use in students in an Italian medical school and investigated the differences between gender and year of study. MATERIALS AND METHODS: This cross-sectional study included 694 medical students in their 1st (n = 286), 4th (n = 209), and 6th (n = 199) year of study. The questionnaire included demographic information, self-report questionnaires regarding depression, anxiety, and stress, and questions about psychiatric drug use. Data analysis was performed using SPSS/Ver 22 through descriptive and analytic statistics, including Mann-Whitney U-test, Fisher's exact test, and GLM two-way ANOVA. RESULTS: Depression, anxiety, and stress symptoms were reported by 365 (52.6%), 428 (61.7%), and 545 (78.5%) medical students, respectively. Female students in their 4th year of study reported higher depression levels than males of the same year (P = 0.004), whereas levels of anxiety were higher in 6th-year female students compared with those in their 1st and 4th years (P = 0.001; P = 0.025). Stress levels were consistently higher in females than in males for all 3 years (1st year: P = 0.041; 4th year: P < 0.001; 6th year: P = 0.004). No gender differences were found in the use of psychiatric and stimulant drugs. CONCLUSION: This study provides preliminary evidence suggesting the importance of planning interventions aimed at reducing emotional distress among medical students that should be targeted on gender and year of the study.

A Qualitative Study Regarding COVID-19 Inpatient Family Caregivers' Need for Supportive Care.

BACKGROUND: Family caregivers of COVID-19 inpatients are exposed to multiple sources of distress. These include not only losing friends, colleagues and members of the family, but also the fear of possible losses in sociality, finances and, impoverished communication with sick family members and health care providers. OBJECTIVE: This study describes the psychological experience of COVID-19 inpatient family caregivers to highlight the main sources of distress, issues, concerns and unmet needs. METHODS: Two focus groups were independently organized with COVID-19 inpatient family caregivers and health care personnel of COVID-19 wards in order to highlight family caregivers' practical and psychological burden and related needs. A thematic analysis was conducted to analyze the data. RESULTS: Family caregivers mentioned they needed more information about the patient's condition with more attention being paid to their own emotional state. Feelings of impotence, concerns about how to deal with patient's discharge, significant psychological distress, and anxiety were frequently reported by study participants. CONCLUSION: Study findings suggest the need to strengthen the assistance of COVID-19 patient family caregivers. In the pandemic scenario, family caregivers might represent a crucial resource, which can guarantee rapid discharges, support home health care and thus relieve pressure on hospital systems.

Effectiveness of a brief manualized intervention, Managing Cancer and Living Meaningfully (CALM), adapted to the Italian cancer care setting: Study protocol for a single-blinded randomized controlled trial.

Patients with advanced cancer suffer from psychosocial distress that may impair quality of life and that may be ameliorated by psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial (RCT) to assess the effectiveness of a novel, brief, semi-structured psychotherapeutic intervention to reduce distress and increase well-being in patients with advanced or metastatic cancer. The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT). The study is a single-blinded phase III RCT with assessment at baseline, 3 and 6 months with two conditions: CALM-IT versus a nonspecific supportive intervention (SPI). Eligibility criteria include: ≥ 18 years of age; fluency in the Italian language; no cognitive deficit, and diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months. CALM-IT includes up to 12 sessions, delivered over 6 months and covers 4 domains: i) Symptom Management and Communication with Health Care Providers; ii) Changes in Self and Relations with Close Others; iii) Sense of Meaning and Purpose; and iv) the Future and Mortality. The primary outcome is difference in severity of depressive symptoms between treatment arm and the primary endpoint is 6 months. The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care. If shown to be effective, CALM-IT can be implemented nationally to relieve distress and to promote psychological well-being in patients with advanced cancer.

Psychometric assessment of the Italian version of the melanoma module (SCNS-M12-Ita) of the Supportive Care Needs Survey (SCNS-SF34).

INTRODUCTION: This study examines the validity and the reliability of the translated-into-Italian version of the SCNS-SF34 melanoma module (SCNS-M12-Ita) for a sample of patients with melanoma (n = 268). METHODS: Content validity was analyzed by examining the redundancy of items. Floor/ceiling effects were investigated via frequency tables. Factor structure was studied through principal component analysis. Internal consistency was evaluated with Cronbach α. Test-retest reliability was analyzed using intraclass correlation coefficients (ICCs). Convergent-discriminant validity was studied by calculating Pearson correlations. Construct validity was investigated by comparing subgroups of patients through multivariate analysis of variance. RESULTS: Content validity of the SCNS-M12-Ita was satisfactory. The floor effect ranged from 24.3% to 82.5%. The 2-factor solution explained 61.4% of the total variance. Internal consistency was excellent for component 1 (α = 0.92) and questionable (α = 0.58) for component 2. Test-retest reliability was excellent for component 1 (ICC = 0.92) and poor for component 2 (ICC = 0.58). Except for component 2, item-total correlations were greater than 0.60. Construct validity was confirmed, as the expected correlations (r < 0.40) were observed and 60% of the postulated hypotheses about between-group differences were confirmed. CONCLUSIONS: The study demonstrated that the SCNS-M12-Ita is a valid and reliable instrument for assessing the supportive care needs of patients with melanoma.

Prevalence and correlates of the supportive care needs of Italian early-stage melanoma patients in follow-up.

Purpose: To describe the supportive care needs of early-stage Italian melanoma patients and identify the predictors of unmet needs. Design: Bicenter cross-sectional. Sample: Two hundred eight (TIS-T3) melanoma patients in follow-up. Methods: In person self-assessment procedures; the Supportive Care Needs Survey short-form 34, the Distress Thermometer and the Hospital Anxiety and Depression Scale were used. Results: Of the patients surveyed, 56% experienced at least one or more moderate-to-high unmet needs. Lack of melanoma-specific information and psychological support aids were the most intense sources of need. Being aged 60-69 years, retired and distressed predicted unmet needs. Conclusions: This study's results demonstrate the need to implement supportive care needs screening among Italian early-stage melanoma patients during follow-up and to improve patient information and psychological support. Implications for psychosocial providers or policy: Providing patients with a point person within the hospital staff who centralizes the demand and refers to appropriate interventions may help the management of unmet needs.

Refining the Frommelt Attitude Toward the Care of the Dying Scale (FATCOD-B) for medical students: A confirmatory factor analysis and Rasch validation study.

OBJECTIVE: Given the increasing number of patients requiring palliative care and the need for more professionals who are able to provide care for the dying comfortably, assessment of medical attitudes toward end-of-life care is becoming a key aspect of medical education. The present study aimed to establish whether the Frommelt Attitude Toward the Care Of the Dying, Form B (FATCOD-B) meets current psychometric standards of validity for an assessment tool in medical education. METHOD: The participants were 200 undergraduate medical students. Since in a previous study the FATCOD-B was found to have a weak structure due to poor item validity, a refined version was proposed and tested in the present study. Confirmatory factor analysis and the Rasch model were employed to assess its dimensionality and psychometric properties. RESULTS: The construct measured by the FATCOD-B continues to be misspecified. The tool has a two-dimensional structure. The first is well-structured and demonstrates appreciable measurement and discriminant capabilities. The second has low validity because its measurement capabilities are based on weakly correlated items. SIGNIFICANCE OF RESULTS: Our results suggest that the FATCOD-B measures a two-dimensional construct and that only its first dimension is a robust measurement tool for use in medical education to evaluate undergraduates' attitudes about caring for the dying.

Medical Students Reflections Toward End-of-Life: a Hospice Experience.

In this study, we want to investigate the personal reflections toward care of the dying cancer patients among second year medical students. Two hundred fifty second year medical students attended an elective short course on end-of-life care and a brief training at the hospice Valletta, in Turin. After group discussion, the students explained their reflections about their experience. Two different supervisors of the study analyzed themes of the students and subdivided them in categories according to the frequency. The most recurrent themes were symptoms, coping skills, distress, hospice, and insight. Each theme is subdivided in categories. In 95 of 250 transcriptions, students talked about symptom (38%), 60 transcriptions (24%) were focused on coping skills. In 45 transcriptions (18%) students described emotional distress, and in the other 30 (12%) transcriptions, they pinpointed hospice philosophy. Finally, 20 recorded data (8%) were characterized by insight theme. These results have emphasized the need to integrate the clinical training with an experiential training that prepares future doctors for dealing with suffering and death. The qualitative analysis of the reflections showed that the students gained a deep appreciation of the human identity of hospice patients and the relevance of a humanistic approach to care as future physicians.

Harm Avoidance and Self-Directedness Characterize Fibromyalgic Patients and the Symptom Severity.

OBJECTIVE: Evidence in the literature suggests peculiar personality traits for fibromyalgic (FM) patients, and it has been suggested that personality characteristics may be involved in patients' different symptomatic events and responses to treatment. The aim of the study is to investigate the personality characteristics of Italian FM patients and to explore the possibility of clustering them considering both personality traits and clinical characteristics. DESIGN: The study used a cross-sectional methodology and involved a control group. A self-assessment procedure was used for data gathering. The study included 87 female FM patients and 83 healthy females. Patients were approached and interviewed in person during a psychiatric consultation. Healthy people were recruited from general practices with previous telephone contact. MAIN OUTCOME MEASURES: Participants responded to the Hospital Anxiety and Depression Scale, the Temperament and Character Inventory, the Fibromyalgia Impact Questionnaire and the Short-Form-36 Health Survey. RESULTS: FM patients scored significantly different from healthy participants on the Harm avoidance (HA), Novelty seeking (NS) and Self-directedness (SD). Two clusters were identified: patients in Cluster1 (n = 37) had higher scores on HA and lower scores on RD, SD, and Cooperativeness and reported more serious fibromyalgia and more severe anxious-depressive symptomatology than did patients in Cluster2 (n = 46). CONCLUSION: This study confirms the presence of certain personality traits in the FM population. In particular, high levels of HA and low levels of SD characterize a subgroup of FM patients with more severe anxious-depressive symptomatology. According to these findings, personality assessment could be useful in the diagnostic process to tailor therapeutic interventions to the personality characteristics.