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.

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.

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.

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.

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.

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.

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.

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.

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.

A randomised controlled trial comparing duloxetine and acetyl L-carnitine in fibromyalgic patients: preliminary data.

OBJECTIVES: Fibromyalgia syndrome (FMS) is a chronic disorder characterised by widespread musculoskeletal pain, troubled sleep, disturbed mood, and fatigue. Recently published reviews have demonstrated that it is influenced by various psychological aspects, and antidepressants are now considered the treatment of choice for most patients. The aim of this randomised controlled trial was to compare the effects of duloxetine and acetyl L-carnitine on pain, depression, anxiety and well-being in FMS patients. METHODS: Sixty-five female outpatients with FMS diagnosed by a rheumatologist were recruited between January 2011 and May 2012, and randomised to receive duloxetine 60 mg/day or acetyl L-carnitine 1500 mg/day (500 mg t.i.d.). Drug efficacy and side effects were assessed by the same psychiatrist at baseline, and four and 12 weeks later. RESULTS: Both drugs led to a general clinical improvement, with positive effects on pain and depressive symptoms; but neither induced a significant improvement in anxiety. Both drugs had a positive effect on the physical component of the quality of life, but only duloxetine improved the psychological component. CONCLUSIONS: Although they need to be confirmed by further studies, these preliminary findings confirm the efficacy of duloxetine, and suggest that acetyl L-carnitine is also efficacious in improving depressive symptoms, pain, and the quality of life of FMS patients.

Confirmatory factor analysis of the Frommelt Attitude Toward Care of the Dying Scale (FATCOD-B) among Italian medical students.

OBJECTIVE: A steady increase in the number of patients requiring end-of-life care has been observed during the last decades. The assessment of healthcare students' attitudes toward end-of-life care is an important step in their curriculum, as it provides information about their disposition to practice palliative medicine. The Frommelt Attitude Toward Care of the Dying Scale (FATCOD-B) was developed to detect such a disposition, but its psychometric properties are yet to be clearly defined. METHOD: A convenience sample of 608 second-year medical students participated in our study in the 2012/2013 and 2013/2014 academic years. All participants completed the FATCOD-B. The sample was randomly divided in two subsamples. In the item analysis, reliability (Cronbach's α), internal consistency (item-total correlations), and an exploratory factor analysis (EFA) were conducted using the first subsample (n = 300). Using the second subsample (n = 308), confirmatory factor analysis (CFA) was performed using the robust ML method in the Lisrel program. RESULTS: Reliability for all items was 0.699. Item-total correlations, ranging from 0.03 to 0.39, were weak. EFA identified a two-dimensional orthogonal solution, explaining 20% of total variance. CFA upheld the two-dimensional model, but the loadings on the dimensions and their respective indicators were weak and equal to zero for certain items. SIGNIFICANCE OF RESULTS: The findings of the present study suggest that the FATCOD-B measures a two-dimensional construct and that several items seem in need of revision. Future research oriented toward building a revised version of the scale should pay attention to item ambiguity and take particular care to distinguish among items that concern emotions and beliefs related to end-of-life care, as well as their subjects (e.g., the healthcare provider, the patient, his family).

Second-year Italian medical students' attitudes toward care of the dying patient: an exploratory study.

To our knowledge, no other study has investigated Italian medical students' attitudes toward care of the dying patient. The purpose of this study is to investigate those attitudes among second-year Italian medical students. Two-hundred students completed the Italian version of the Frommelt Attitude Toward Care of the Dying Scale form B (FATCOD Form B). Students obtained a mean total score on FATCOD Form B of 112.8 (the possible total score ranges from 30 to 150). On some items, statistically significant differences (p < 0.05) emerged for gender and personal previous experiences with terminally ill people. This study shows poor attitudes toward care of the dying patient among second-year Italian medical students, as measured by FATCOD Form B. The need to establish tailored methods in End-of-Life Care education to make students aware of their relationship patterns and to improve students' attitudes toward dying patients is discussed.