The Italian version of the FAMCARE scale: a validation study.

PURPOSE: Evaluation of the quality of care is a key element that healthcare providers now take into consideration to meet patients' needs, expectations, and values. The FAMCARE scale is one of the most important instruments available to assess the level of satisfaction about care received by patients and families. We describe the validation process used to develop an Italian version (IF) of the original FAMCARE scale for caregivers. METHODS: The IF was prepared according to standard guidelines for translation and transcultural adaptation of self-reported measures. The scale was self-administered to 132 informal caregivers of patients with cancer treated with curative and/or palliative care in a hospice, outpatient, or inpatient setting for at least 1 month. The participant group was composed of spouses (47.73 %), children (31.82 %), siblings (3.03 %), or other relatives (17.42 %). All participants simultaneously completed the EuroQol-5D (EQ-5D) questionnaire to test the construct validity. Twenty-two percent of randomly chosen participants re-completed the test after 1 month to evaluate IF test-retest stability. RESULTS: The IF showed a strong reliability with internal consistency [α = 0.93, confidence intervals (CI) = 0.91-0.95] and test-retest stability (Pearson r = 0.38; Kendall's tau-b = 0,25; Spearman's rho =0.34). Factor analysis identified four factors capable of explaining the 63 % total variance which did not change after the Varimax normalized rotation. Notwithstanding the lack of correlation with the VAS component of the EQ-5D questionnaire, our results highlighted robust psychometric properties of the IF. CONCLUSIONS: IF is a valid translation of the FAMCARE scale and can be used to assess caregiver satisfaction within the Italian context of cancer palliative care.

Translation of Supportive Care Needs Survey Short Form 34 (SCNS-SF34) into Italian and cultural validation study.

BACKGROUND: The Supportive Care Needs Survey (SCNS) is one of the most comprehensive tools used in the clinical trials to measure the perceived unmet supportive care needs of cancer patients. The original 59-item instrument was developed and validated in English using rigorous methods. A short version containing 34 items was subsequently developed by the same authors (SCNS-SF34) and has since been translated into numerous other languages and validated, confirming its psychometrically robust properties. Cross-cultural validity is, in fact, important for international comparisons of self-reported measures. As an Italian form of the questionnaire does not exist at present, we decided to test the linguistic equivalence and cultural validity of a translated version of the SCNS-SF34 in a target population. METHODS: The adaptation process was performed in accordance with Beaton's guidelines by a dedicated research team in collaboration with patient representatives. RESULTS: The Italian questionnaire maintained the construct validity of the original version and was easy to understand and use. CONCLUSIONS: Preliminary results indicate that the SCNS-SF34 is feasible in an Italian population. Further research is ongoing at our institute to assess its psychometric properties in a larger case series and in different care settings.

Validity, reliability and responsiveness to change of the Italian palliative care outcome scale: a multicenter study of advanced cancer patients.

BACKGROUND: There is an increasing requirement to assess outcomes, but few measures have been tested for advanced medical illness. We aimed to test the validity, reliability and responsiveness of the Palliative care Outcome Scale (POS), and to analyse predictors of change after the transition to palliative care. METHODS: Phase 1: multicentre, mixed method study comprising cognitive and qualitative interviews with patients and staff, cultural refinement and adaption. Phase 2: consecutive cancer patients on admission to 8 inpatient hospices and 7 home-based teams were asked to complete the POS, the EORTC QLQ-C15-PAL and the FACIT-Sp (T0), to assess internal consistency, convergent and divergent validity. After 6 days (T1) patients and staff completed the POS to assess responsiveness to change (T1-T0), and agreement between self-assessed POS and POS completed by the staff. Finally, we asked hospices an assessment 24-48 h after T1 to assess its reliability (test re-test analysis). RESULTS: Phase I: 209 completed POS questionnaires and 29 cognitive interviews were assessed, revisions made and one item substituted. Phase II: 295 consecutive patients admitted to 15 PCTs were approached, 175 (59.3 %) were eligible, and 150 (85.7 %) consented. Consent was limited by the severity of illness in 40 % patients. We found good convergent validity, with strong and moderate correlations (r ranged 0.5-0.8) between similar items from the POS, the QLQ-C15-PAL and the FACIT-Sp. As hypothesised, the physical function subscale of QLQ-C15-PAL was not correlated with any POS item (r ranged -0.16-0.02). We found acceptable to good test re-test reliability in both versions for 6 items. We found significant clinical improvements during the first week of palliative care in 7/10 items assessed-pain, other symptoms, patient and family anxiety, information, feeling at peace and wasted time. CONCLUSIONS: Both the patient self-assessed and professional POS versions are valid and with an acceptable internal consistency. POS detected significant clinical improvements during palliative care, at a time when patients are usually expected to deteriorate. These results suggest that there is room for substantial improvement in the management of patients with advanced disease, across all key domains-symptoms, psychological, information, social and spiritual.

Cancer patients' emotional distress, coping styles and perception of doctor-patient interaction in European cancer settings.

OBJECTIVE: As a part of a European study, we cross-culturally examined the rate of emotional distress and maladaptive coping and their association with cancer patients' satisfaction with their interactions with the physician responsible for their care. METHODS: Cancer patients (n = 302) from one Middle European (Austria) and two Southern European (Italy, Spain) countries completed the NCCN Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC) Anxious Preoccupation (AP) and Hopelessness (H) sub-scales, and the Physician Patient Satisfaction with Doctors Questionnaire (PSQ). RESULTS: The prevalence of emotional distress (DT caseness) was 60% (26.1% mild, 18.8% moderate, and 14.9% severe distress). Maladaptive coping (Mini-MAC cases) was found in 22.8% (hopeless cases), and 22.5% (anxious preoccupation cases). PSQ-MD was significantly correlated with Mini-MAC/H and Mini-Mac/AP, while PSQ-PS was negatively correlated with Mini-MAC/H. DT cases and those with higher levels of hopelessness reported higher scores on PSQ-MD and lower on PSQ-PS than non-cases. Some differences were found between countries both as far as patients' coping and perception of the interaction with doctors. In hierarchical multiple regression analysis, after adjusting for socio-demographic and medical variables, Mini-MAC/H significantly predicted the scores on PSQ-MD (positive direction) and PSQ-PS (negative direction). SIGNIFICANCE OF RESULTS: The study confirms that about one out of three cancer patients have moderate to high level of emotional distress and about one out of four, clinically significant maladaptive coping. Also, patients showing hopelessness and distress tended to perceive their doctors as both disengaged and less supportive. These results highlights the need for physicians to monitor their patient's level of distress and coping mechanisms and to adjust their own relational and communication style according to patients' psychological condition. Also, cross-cultural issues should be taken into account when exploring psychosocial variables and cancer patients' perception of and satisfaction with the interaction with their doctors.

Role of psychosocial variables on chemotherapy-induced nausea and vomiting and health-related quality of life among cancer patients: a European study.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) continue to be a distressing problem still reported by cancer patients, with negative consequences on quality of life (QoL). AIMS: To prospectively explore the association of psychosocial variables, including emotional distress, maladaptive coping styles and the doctor-patient relationship, with CINV and QoL among cancer outpatients. METHODS: A prospective study was conducted on 302 consecutive cancer patients (response rate 80.9%) in Austria, Italy and Spain. The Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC), and the Patient Satisfaction with Doctor Questionnaire (PSQ) were used to assess psychosocial variables before chemotherapy. In the 5 days after chemotherapy, CINV was examined by using a daily diary, and the Functional Living Index for Emesis (FLIE) was used to assess QoL. RESULTS: More than half of the patients reported nausea (54%), and a small percentage reported vomiting (14%). CINV had a negative impact on QoL (FLIE caseness, p < 0.01). Maladaptive coping (i.e. hopelessness-helplessness and anxious preoccupation) and emotional distress were associated with CINV (p < 0.05) and poorer QoL (p < 0.05). In logistic regression analysis, nausea was predicted by Mini-MAC/H (OR = 1.1, p = 0.03) and younger age (OR = 0.97, p = 0.04); negative impact on QoL was predicted by grade of chemotherapy emetogenesis (OR = 1.7, p < 0.01) and Mini-MAC/H (OR = 1.2, p = 0.04). CONCLUSIONS: Screening and assessment of psychological variables, especially coping, could help in identifying cancer patients at risk for chemotherapy-induced nausea, in spite of the use of antiemetic treatment.

Management of delirium in palliative care: a review.

Delirium is a complex but common disorder in palliative care with a prevalence between 13 and 88 % but a particular frequency at the end of life (terminal delirium). By reviewing the most relevant studies (MEDLINE, EMBASE, PsycLit, PsycInfo, Cochrane Library), a correct assessment to make the diagnosis (e.g., DSM-5, delirium assessment tools), the identification of the possible etiological factors, and the application of multicomponent and integrated interventions were reported as the correct steps to effectively manage delirium in palliative care. In terms of medications, both conventional (e.g., haloperidol) and atypical antipsychotics (e.g., olanzapine, risperidone, quetiapine, aripiprazole) were shown to be equally effective in the treatment of delirium. No recommendation was possible in palliative care regarding the use of other drugs (e.g., α-2 receptors agonists, psychostimulants, cholinesterase inhibitors, melatonergic drugs). Non-pharmacological interventions (e.g., behavioral and educational) were also shown to be important in the management of delirium. More research is necessary to clarify how to more thoroughly manage delirium in palliative care.