End-Of-Life Cancer Patients' Dignity Perception Before and During COVID-19 Pandemic.

Background: The safety and restriction regulations implemented to contain the COVID-19 pandemic significantly impacted people's quality of life compromising the perception of dignity. Preserving dignity for end-of-life patients remains a paramount objective in palliative care. This study aimed to compare dignity levels in terminal cancer patients between pre- and during-pandemic periods. Methods: Dignity was assessed by the Italian version of the Patient Dignity Inventory (PDI-IT) in both pre- and during-pandemic groups of terminal cancer inpatients (hospitalized or admitted in hospice). The 2 groups were compared using non-parametric tests and a multivariate logistic regression analysis to estimate the association of the different dimensions of dignity with COVID-19 period, adjusting for other confounders. The study involved 2 groups of end-of-life cancer patients with a Karnofsky Performance Status (KPS) index less than 50. The first group included 506 patients before COVID-19, and the second group consisted of 156 patients enrolled during pandemic. Results: Existential Distress, Loss of Purpose and Meaning, Physical Symptoms and Dependency, Social Support PDI subscales and PDI Total score were higher in the during-pandemic group. The multivariate regression model partially supported the previous results as Loss of Purpose and Meaning, Social Support, and Existential Distress PDI subscales were associated with during-pandemic period, whereas PDI Physical Symptoms and Dependency and PDI Psychological Distress were not. Conclusion: Social isolation and other restrictions put in place to contain the COVID-19 pandemic may have had a negative impact on the perception of dignity in cancer patients at the end of life.

Spiritual issues, beliefs, needs, and resources in palliative healthcare providers: An Italian qualitative study.

The significance of spirituality in navigating the meaning of illness and death has been well-established. However, healthcare professionals working with palliation also grapple with their own spiritual dimensions when confronted with these circumstances. This study aimed to explore spirituality from a subjective standpoint among a sample of palliative care professionals, investigating its role and associated needs. For the first time, the FICA Spiritual History Tool was applied in a focus group setting. The meetings were transcribed, and thematic analysis was performed. The findings underscore how spirituality is perceived as more relational than transcendent, potentially fostering connections between the self, patients, and colleagues, thereby enhancing resilience. Simultaneously, spirituality needs to be considered as a potential source of suffering that could impact both the quality of life and work of healthcare workers involved. This issue should be addressed through dedicated moments of shared reprocessing, with beneficial implications for public health.

Loss of Personal Autonomy and Dignity-Related Distress in End-Of-Life Cancer Patients.

The objective of this cross-sectional study is to investigate Dignity-Related Loss of Personal Autonomy (DR-LPA) intended as loss of relational independence causing dignity-related distress. Moreover, it analyzes its possible relationships with demoralization, spirituality, quality of life, hope, and coping styles in a sample composed of 207 end-of-life cancer patients. These variables have been assessed through the following rating scales: Patient Dignity Inventory - Italian version, Demoralization Scale - Italian version, Functional Assessment of Cancer Therapy Scale - General Measure, Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being, Brief Coping Orientation to Problem Experienced, and Herth Hope Index. The results have shown that most of the DR-LPA items were considered a problem by most patients. Functional, social, emotional, and spiritual wellbeing, disheartenment, age, and sex emerged as significant predictors of DR-LPA. In conclusion, this study showed that DR-LPA can be a relevant concern for patients at the end-of-life and for this reason it becomes necessary for psychosocial provides to consider it to deliver better dignity conserving care.

The Italian versions of the This Is ME Questionnaire and the Patient Dignity Question: Understanding personhood and supporting dignity in patients with terminal cancer.

OBJECTIVES: Patients with cancer at the end of life may suffer from high psychological distress, a sense of demoralization, and a lack of dignity related to their medical condition. The This Is ME (TIME) Questionnaire and the Patient Dignity Question (PDQ) are clinical tools developed to achieve comprehensive and personalized patient care and to deepen our understanding of personhood. The objective of this study was to translate and validate the TIME Questionnaire, which contains the PDQ, into Italian to evaluate patient satisfaction of the Italian version of these tools and to identify essential themes elicited by the tools. METHODS: The validation process consisted of a forward and back translation stage, data collection from a sample of 60 patients with terminal cancer, and a final consultation with a panel of experts to identify patient themes using the results of the tool. RESULTS: Overall, participants felt that the PDQ/TIME questionnaire captured their essence as a person, allowed them to express their values and beliefs, and helped the health care professionals (HCP) to take better care of them. Content analysis identified "family relationships," "global pain," and "family roles and accomplishments" as being of most importance to patients. SIGNIFICANCE OF RESULTS: The Italian versions of the PDQ/TIME Questionnaire are clear, precise, understandable, and focused on understanding personhood in patients with advanced cancer. These tools should be used to proactively enhance patient-caregiver and patient-HCP relationships and to develop new perspectives of patient care focused on the critical dimension of personhood.

Self-Transcendence: Association with Spirituality in an Italian Sample of Terminal Cancer Patients.

Terminally ill cancer patients often experience demoralization and loss of dignity, which undermines their spiritual wellbeing, which could, however, be supported by the presence of other factors such as self-transcendence and religious coping strategies. To assess self-transcendence and religious coping strategies and how they influence spirituality, we studied 141 end-stage cancer patients (64.3% male; mean age 68.6 ± 14.6) with a Karnofsky Performance Status ≤ 50 and a life expectancy ≤ 4 months using the Self-Transcendence Scale, the Demoralization Scale, the Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp-12), the Brief Religious COPE, and the Patient Dignity Inventory. To understand the effects of these variables on spirituality, hierarchical multiple regression was performed on FACIT-Sp-12. The final model predicted 67% of the variance in spiritual wellbeing. Demoralization was the strongest influencing factor (ß = -0.727, p < 0.001), followed by self-transcendence (ß = 0.256, p < 0.001), and positive religious coping (ß = 0.148, p < 0.05). This study suggests that self-transcendence and positive religious coping may be protective factors for spirituality in terminal cancer patients. These factors should be considered in treatment to promote spiritual wellbeing and improve patients' quality of life at the end of life.

Relationship between demoralization and quality of life in end-of-life cancer patients.

OBJECTIVE: To examine the relationship between demoralization and health-related quality of life (HRQoL) in a sample of end-of-life cancer patients with a life expectancy of 4 months or less undergoing palliative care, controlling for sociodemographic, clinical, and psychological variables. METHODS: Sociodemographic, clinical, and psychological data from 170 end-of-life cancer patients were collected using the following scales: Edmonton Symptom Assessment System for palliative care patients' symptoms; Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms; Functional Assessment of Cancer Therapy Scale - General Measure (FACT-G) for HRQoL; Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being for spirituality (FACIT-Sp); Demoralization Scale - Italian Version (DS-IT) for demoralization. RESULTS: The DS-IT showed that 51.8% of cancer patients were severely demoralized. In addition, 36.5% of the sample had clinically significant depressive symptoms and QoL was severely impaired (FACT-G). The result of regression analysis showed that demoralization (especially "Disheartenment" and "Sense of failure") was the strongest contributor for HRQoL, followed by ESAS_Lack of Well-Being and depression (PHQ-9), with the final model explaining 66% of the variance of the FACT-G. CONCLUSIONS: The results highlight a very high prevalence of severe demoralization in end-of life cancer patients. Moreover, demoralization was not only associated with patients' HRQoL, but it was also the most important contributing factor. This finding underscores the need to identify preventive or therapeutic psychological interventions that focus on preventing existential distress, and thus improve the QoL of dying patients in their last days of life.

Compassion: Learning Needs and Training Opportunities-a Survey Among Palliative Healthcare Providers in Italy.

Compassion is a key quality in palliative care; however, there is a lack of evidence of the need to discuss the theme of compassion and professionals' training in the subject. The study aimed to investigate the knowledge of the construct of a sample of Italian healthcare professionals (HCPs) working in palliative care. In addition, their learning needs and training opportunities were explored. An online survey was completed by 330 HCPs. It was divided into five sections which examined knowledge of the construct of compassion and the perception of its utility in palliative care, the activities carried out in eventual training in compassion, and professionals' learning needs thereof. Professionals who had knowledge of the right definition of compassion considered it more useful and training more necessary. Most of the sample never received training about compassion. However, 97% of those who received training believed it to be necessary. Satisfaction with training was higher among those who received multidisciplinary team education. Training occasions are relatively rare in the Italian context, although they seem to increase knowledge and awareness about the construct utility and training necessity. Besides, multidisciplinary team training seems to be more satisfying. Offering team training on compassion can promote a deeper awareness of it and of its utility in clinical practice.

Is there a relationship between end-of-life cancer patients' dignity-related distress and caregivers' distress? An exploratory study.

OBJECTIVES: The mutual influence between end-of-life cancer patients and their family caregivers is widely endorsed. The present study aimed to explore the relationship between end-of-life cancer patients' dignity-related distress and the distress of their caregivers. METHOD: A cross-sectional approach was used. The sample consisted of 128 patients with a Karnofsky Performance Status (KPS) below 50 and a life expectancy of a few weeks, and their family caregivers. Personal and clinical data were collected and validated rating scales were administered: Patient Dignity Inventory (PDI) to terminal cancer patients; Hospital Anxiety and Depression Scale (HADS), Demoralization Scale (DS), Herth Hope Index (HHI), Caregiver Reaction Assessment (CRA), Short Form Health Survey 36 (SF-36), and Distress Thermometer (DT) to caregivers. RESULTS: Findings highlighted significant correlations between patients' scores on the Psychological Distress PDI subscale and the PDI Total Score and caregivers' Emotional Role. Patients' Psychological Distress, PDI Total Score, and Loss of Purpose and Meaning were associated with caregivers' Disrupted Schedule. Finally, patients' Physical Symptoms and Dependency, Loss of Purpose and Meaning, and PDI Total Score were correlated with caregivers' Disheartenment. SIGNIFICANCE OF RESULTS: The results highlighted the key role of dignity as a relational dimension during the end-of-life phase. Therefore, because of caregivers' distress could affect patients' dignity-related distress by influencing the interpersonal aspects of patients' autonomy, it would be important to relieve caregivers' distress in order to promote patients' autonomy and minimize their fear of being a burden.

Factors Associated with Post-Traumatic Growth during the COVID-19 Pandemic: A Systematic Review.

The COVID-19 pandemic was an unprecedented event that further stimulated the debate on the concept of trauma. To increase knowledge about the traumatic potential of the pandemic, the main objective of this study was to identify, through a systematic literature review, the main factors associated with the adaptive outcome of post-traumatic growth caused by COVID-19. Studies were selected from the PsychInfo, Embase, and PubMed databases, and 29 articles were included at the end of the screening process. The identified factors are of different natures, including personal variables such as personality traits, coping, and cognitive strategies used to face adversity, and interpersonal variables, one of the most important of which is the level of social support. In addition, several results confirmed a relationship between post-traumatic growth and post-traumatic stress symptoms, as well as indices related to psychological well-being. Finally, the results are discussed by comparing them with those already present in the literature, as well as with some of the main explanatory models of post-traumatic growth. In this regard, some of the factors identified, such as maladaptive coping, avoidance symptoms, optimism, and low-stress tolerance, suggest the possibility that the process of post-traumatic growth may also be characterized by an illusory dimension.

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.

End-of-life cancer patients' total pain: the necessity to supplement pharmacology with psycho-socio-spiritual treatments.

Aim: To analyze pain considering its different bio-psycho-social-spiritual manifestations and to assess the effectiveness of the analgesic treatments in end-of-life cancer patients. Materials & methods: The study was cross-sectional. A total of 376 end-of-life cancer inpatients participated in the research. Their socio-demographic and clinical data were collected and, during the first psychological consultancy, they filled in a set of validated rating scales assessing pain, anxiety, depression and quality of life. Results: The results show that physical pain was well managed for almost all patients. Nevertheless, the majority showed clinically significant levels of psychological distress. Conclusion: Treating pain means caring for all its possible manifestations including psychological symptoms and reduced wellbeing. Thus, integrating pharmacological treatment with psycho-socio-spiritual interventions, in other words, psychological, social and spiritual support, could be effective and desirable.

The aim of this article was to analyze in patients with oncological disease at the end-of-life different types of pain from which they can suffer, for example, physical pain, psychological distress and their various types of wellbeing. Moreover, we would like to assess if the drugs they assumed for their physical pain were sufficient to remove the pain. A total of 376 patients participated in the research. Their personal and medical data were gathered and they were invited to fill in some questionnaires investigating the presence of pain, anxiety, depression and quality of life. The results showed that physical pain was contained and well treated for almost all patients. Nevertheless, most of the patients had high anxiety and depression and low quality of life. It is important to provide patients with adequate pharmacological treatment, but also to offer them other types of interventions such as psychological support, psychotherapy, social support and spiritual support. Combining the pharmacological treatment with these interventions could be desirable to care for all the possible types of pain.

Hospice palliative care professionals' opinions, emotions, skills and ethical reflections during the first phase of the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic presented an extraordinary challenge for palliative care in Italy. AIM: To investigate the opinions, emotions, skills, resources, critical issues and ethical aspects of palliative care encountered by hospice palliative care professionals in Italy. METHODS: Content analysis was performed on the answers to a survey distributed by e-mail. FINDINGS: A sample of 42 professionals completed the survey. They commonly experienced the pandemic as a challenging situation that highlighted the need for an upgrade to the Servizio Sanitario Nazionale (SSN). Conflicting emotions emerged, namely fear, frustration and sadness, but also hope and solidarity. The lack of adequate personal protective equipment and the fact that caregivers were unable to access their patients due to concerns of infection were the most critical problems. The need for greater training on communication skills and training on end-of-life issues were emphasised by the participants of the survey. Regarding ethical aspects of providing palliative care during the COVID-19 pandemic, the importance of guaranteeing humane care and patients' dignity was mentioned. CONCLUSION: The importance of specific training regarding end-of-life care and the central role of empathic communication were confirmed.

Psychosocial factors associated with complicated grief in caregivers during COVID-19: Results from a preliminary cross-sectional study.

The COVID-19 pandemic has changed how end-of-life ceremonies are performed, affecting grief processing and bereavement experiences. In this study, caregivers of patients who died with COVID-19 during the first wave of the pandemic were asked to complete an online survey designed to detect psychosocial factors associated with the presence of complicated grief (CG). The results show CG present in 48.4% of caregivers. The marital and cohabitant status during lockdown, the perceived sense of guilt and depression levels were significantly associated with the presence of CG, whereas attendance at the funeral and social support were found to be significant protective factors.

A Qualitative Study to Explore Healthcare Providers' Perspectives on End-of-Life Patients' Dignity. How Can Dignity Be Defined, and Which Strategies Exist to Maintain Dignity?

Dignity is a core topic within palliative care, and thus, it is important to get a detailed assessment of healthcare providers' (HCPs) perspectives on this subject. This study aimed to explore various HCPs' perspectives on end-of-life patients' dignity by collecting different testimonies about what dignity entails and which strategies HCPs use to maintain patients' dignity. A sample of 104 participants was interviewed using two open questions to collect qualitative data. Content analysis was performed to identify the central themes among answers. Regarding the first question ("What comes to your mind when I say "Dignity" in relation to your patients?"), nine themes emerged. The majority sampled stated that dignity means respecting the patient by considering him/her as a person in his/her entirety. Two other themes frequently emerged: "Respect the patient's will/wishes/needs" and "Self-determination/Self-expression." Concerning the second question ("Which strategies do you use to maintain patients' dignity?"), seven themes emerged. The "Caring skills" theme was most frequently identified, followed by "Empathic skills" and "Professional strategies." This study has enabled a better understanding of HCPs' perspectives on end-of-life patients' dignity. Through the interviews, HCPs were given an opportunity to reflect on dignity, possibly helping them improve their understanding of their patients' conditions and promote higher quality of care.

Demoralization in End-of-Life Cancer Patients' Family Caregivers: A Cross-Sectional Study.

OBJECTIVES: The aims of this study were to evaluate the prevalence of demoralization in a sample of end-of-life cancer patients' family caregivers and investigate the association between demoralization and different factors, such as distress, hope, quality of life, and caregiver burden. METHODS: The study used a cross-sectional design and 142 participants were sampled. Family caregivers were included if they were caring for a cancer patient in palliative care with a limited life expectancy.Socio-demographic data were gathered, and Italian versions of the following scales were administered: Demoralization Scale (DS), Herth Hope Index (HHI), Caregiver Reaction Assessment (CRA), Short Form-36 Health Survey (SF-36), and Distress Thermometer (DT). RESULTS: The average total demoralization score was 29.04 (SD = 13.62). 19.50% of caregivers was the low scorers at DS (0-25th percentile), 27.50% was the middle scorers (25th-75th percentile), and 39.00% was the high scorers (75th-100 percentile). 19.50% of the caregivers showed mild demoralization, 27.50% moderate demoralization, and 39.00% showed severe demoralization. Strong Moderate correlations were found between the total DS score and the Temporality and Future HHI subscale (ρ = .520); the HHI total score (ρ = .528); the Social functioning (ρ = .536) and Mental health (ρ = .675) SF-36 subscales. The HHI total score and the Mental health SF-36 subscale emerged as the main predictors of demoralization. CONCLUSIONS: The results show that not only end-of-life patients but also family caregivers may experience demoralization. This demoralization seems to be more associated to spiritual and psychological suffering rather than difficulties relating to caregivers' personal time, social roles, physical states, and financial resources.

Interprofessional Communication Team for Caregivers of Patients Hospitalized in the COVID-19 Wards: Results From an Italian Experience.

Background: During the COVID-19 pandemic, emergency restrictions did not allow clinician family meetings and relatives' visits. In Molinette Hospital, a new communication model between healthcare providers and families of COVID-19 affected patients was developed by a team of physicians and psychologists. The study's aims were to investigate caregivers' distress and to analyse their satisfaction with the communications provided. Methods: A cross-sectional study was conducted among caregivers of patients of Molinette Hospital COVID wards. Between April and June 2020, all caregivers were contacted 2 weeks after the patient's discharge/death to assess their satisfaction with the communications received through an online survey. Results: A total of 155 caregivers completed the survey. Caregivers' distress level was found to be higher in women than men (p = 0.048) and in caregivers whose relative died compared to the caregivers whose relative was discharged (p < 0.001). More than 85% of caregivers defined communication "excellent"/"very good"; being male was associated with higher satisfaction levels than women (ß = -0.165, p = 0.046). Besides daily communication, 63 caregivers (40.6%) received additional support from a psychologist of the team. Conclusions: To our knowledge, this is the first study presenting, in an emergency, a new model of communication provided by a team of physicians and psychologists, and analyzing satisfaction with it. This model was highly appreciated by caregivers and it limited the discomfort caused by the restrictions on relatives' visits. It would be interesting to further evaluate the possibility of extending a communication model that includes doctors and psychologists in routine clinical practice.

Personality matters: relationship between personality characteristics, spirituality, demoralization, and perceived quality of life in a sample of end-of-life cancer patients.

PURPOSE: Personality could be an interesting dimension to explore in end-of-life cancer patients, in order to investigate how personality affects quality of life. Thus, this study aimed to investigate the relationship among personality through the Big Five Inventory (BFI), spirituality, and demoralization and to explore their impact on their quality of life. METHODS: A sample of 210 end-of-life Italian cancer patients were assessed with the BFI, the Demoralization Scale (DS), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-SP-12), the Functional Assessment of Cancer Therapy Scale-General Measure (FACT-G), and the Karnofsky performance status. RESULTS: Correlational analysis highlighted a significantly negative relationship between extraversion and agreeableness traits and all the demoralization dimensions. On the other side, neuroticism trait was significantly and positively correlated with the Demoralization Scale (p < 0.01). To understand the impact of these variables on quality of life (FACT-G), we performed a hierarchical multiple regression: in the final model, demoralization remained the strongest contributing factor (ß = - 0.509, p < 0.001), followed by neuroticism (ß = - 0.175, p < 0.001), spirituality (ß = 0.163, p = 0.015), and Karnofsky index (ß = 0.115, p = 0.012). CONCLUSION: Our data underlined how both the neuroticism trait and demoralization are correlated with a worst health status in terminal cancer patients, whereas spirituality is a protective factor. The study of personality may allow to better understand the inner patient's experience and improve communication between patient and healthcare staff in order to build and apply better-tailored psychological treatment.

Hope in end-of-life cancer patients: A cross-sectional analysis.

OBJECTIVE: Hope promotes oncology patients' adaptability to their illness, regardless of the stage of cancer. This study aimed to determine the prevalence of hope in a sample of end-of-life patients and to investigate the possible relationships between hope and a set of clinical and psychosocial measures. METHOD: Three hundred and fifty end-of-life oncology patients, with a presumed life expectancy of 4 months or less and a Karnofsky Performance Status (KPS) of 50 or lower, were administered the Italian validated versions of a set of rating scales during their first consultation with a psychologist. This included the Herth Hope Index (HHI), Patient Dignity Inventory (PDI), Demoralization Scale (DS), Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Chronic Illness Therapy (FACIT-Sp), and the Visual Analogue Scale for pain (VAS). RESULTS: On average, the sample scored between moderate and high on the HHI and the average level of spirituality was high. However, most patients had clinically relevant anxious and depressive symptomatology and high levels of demoralization. Other than the pain scale, the total HHI score significantly correlated with the total scores of all rating scales and their subscales, as well as with the measure of personal religious practice. The "Meaning" FACIT-Sp subscale was found to be the main predictor of hope. SIGNIFICANCE OF RESULTS: Since hope represents a core need and a tool for patients dealing with their illness, it is essential to implement stage-specific and realistic hope-facilitating interventions and support patients in their search for meaning, which promotes spiritual well-being and appears relevant in fostering hope.

Personality Traits and Sense of Dignity in End-of-Life Cancer Patients: A Cross-Sectional Study.

CONTEXT: Patients' personality traits can play an important role in the end-of-life care process. OBJECTIVES: The present study aimed to investigate the relationship between personality traits and dignity in cancer patients nearing death. In addition, the associations between personality traits and physical, psychological symptoms, and coping strategies during the end-of-life stage were explored. METHODS: The study is cross-sectional. The sample consisted of 210 participants with a Karnofsky Performance Status (KPS) lower than 50 and a life expectancy of a few weeks. For each patient, personal and clinical data were collected and a set of validated rating scales, assessing personality, dignity, physical, psychological symptoms and coping strategies was administered during the first psychological consultation. RESULTS: The results highlighted significant associations between personality traits and dignity. In particular, Conscientiousness was negatively correlated with Social Support and Extroversion was negatively associated with Loss of Purpose and Meaning. Neuroticism was related to all the dimensions of dignity and Extroversion was significantly associated with the physical and psychological symptoms. Regarding coping styles, active coping strategies were predictors of Extroversion and Agreeableness. Conversely, anxiety symptoms predicted the Neuroticism trait. CONCLUSIONS: Personality traits seem to be actively involved into the loss of dignity. These findings highlighted the importance of including personality traits and dignity into the patient's care process. Exploring individual differences and coping mechanisms at the end-of-life could improve palliative care and lead to better patient-tailored psychological interventions.

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.