Understanding quality of life issues in patients with advanced melanoma: Phase 1 and 2 in the development of the EORTC advanced melanoma module.

AIMS: We aimed to develop a European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) module tailored for patients with advanced (resectable or unresectable stage III/IV) melanoma receiving immune checkpoint inhibitors or targeted therapy. METHODS: Following the EORTC QoL Group module development guidelines, we conducted phases 1 and 2 of the development process. In phase 1, we generated a list of health-related (HR)QoL issues through a systematic literature review and semi-structured interviews with healthcare professionals (HCPs) and patients with advanced melanoma. In phase 2, these issues were converted into questionnaire items to create the preliminary module. RESULTS: Phase 1: we retrieved 8006 articles for the literature review, of which 35 were deemed relevant, resulting in 84 HRQoL issues being extracted to create the initial issue list. Semi-structured interviews with 18 HCPs and 28 patients with advanced melanoma resulted in 28 issues being added to the initial issue list. Following EORTC module development criteria, 26 issues were removed, and two issues were added after review by patient advocates. Phase 2: To ensure uniformity and avoid duplication, 16 issues were consolidated into eight items. Additionally, an independent expert contributed one new item, resulting in a preliminary module comprising 80 HRQoL items. CONCLUSION: We identified a range of HRQoL issues (dry skin, xerostomia, and arthralgia) relevant to patients with stage III/IV melanoma. Future module development phases will refine the questionnaire. Once completed, this module will enable standardized assessment of HRQoL in patients with (locally) advanced melanoma.

Assessment of self-efficacy for caregiving in oncology: Italian validation of the caregiver inventory (CGI-I).

BACKGROUND: The Caregiver Inventory (CGI), a measure of self-efficacy for caregiving that takes into account aspects of caregiving that are neglected by current measures of caregiving, was translated into Italian and validated. METHODS: Ninety-one caregivers from a variety of locations in Italy completed the CGI-Italian (CGI-I) as well as the Hospital Anxiety and Depression Scale (HADS) and the Family Strain Questionnaire - Short Form (FSQ-SF). RESULTS: A confirmatory factor analysis based on the original CGI factor structure resulted in an adequate fit of the CGI-I using standard fit indices. Thus, the original factor structure was validated in the CGI-I: Managing Medical Information (α = 0.87), Caring for Care Recipient (α = 0.68), Caring for Oneself (α = 0.78), and Managing Difficult Interactions/Emotions (α = 0.55). The CGI-I total score was inversely related to anxiety (HADS, r = - 0.35, p = <.05), and depression (HADS, r = - 0.45, p = <.05). In addition, the CGI-I was inversely related to caregiver stress (FSQ-SF, r = - 0.39, p = <.05). Care of Oneself and Managing Difficult Interactions/Emotions emerged as the strongest and most robust negative relationships with anxiety, depression, and caregiver stress, which replicated, with similar constructs, findings from the original CGI. CONCLUSIONS: The results of this study established the CGI-I as a reliable and valid measure of self-efficacy for caregiving. This study also confirms the importance of self-care and managing difficult communication in the process of successfully navigating the demands of caregiving and in constructing interventions for caregivers who need support.

An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients: EORTC QLQ-BR45.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR23 was one of the first disease-specific questionnaires developed in 1996 to assess quality of life (QoL) in patients with breast cancer (BC). However, since 1996 major changes in BC treatment have occurred, requiring an update of the EORTC BC module. This study presents the results of the phase I-III update of the QLQ-BR23 questionnaire. PATIENTS AND METHODS: The update of the EORTC QLQ-BR23 module followed standard EORTC guidelines. A systematic literature review revealed 83 potential relevant QoL issues during phases I and II. After shortening the issues list and following interviews with patients and health care providers, 15 relevant issues were transformed into 27 items. The preliminary module was pretested in an international, multicentre phase III study to identify and solve potential problems with wording comprehensibility and acceptability of the items. Descriptive statistics are provided. Analyses were qualitative and quantitative. We provide a psychometric structure of the items. RESULTS: The phase I and II results indicated the need to supplement the original QLQ-BR23 with additional items related to newer therapeutic options. The phase III study recruited a total of 250 patients (from 12 countries). The final updated phase III module contains a total of 45 items: 23 items from the QLQ-BR23 and 22 new items. The new items contain two multi-item scales: a target symptom scale and a satisfaction scale. The target symptom scale can be divided into three subscales: endocrine therapy, endocrine sexual and skin/mucosa scale. CONCLUSION: Our work has led to the development of a new EORTC QLQ-BR45 module that provides a more accurate and comprehensive assessment of the impact of new and scalable treatments on patients' QoL. The final version of the EORTC QLQ-BR45 is currently available for use in clinical practice. The final phase IV study is underway to confirm psychometric properties of the module.

The international phase 4 validation study of the EORTC QLQ-SWB32: A stand-alone measure of spiritual well-being for people receiving palliative care for cancer.

The EORTC Quality of Life Group has just completed the final phase (field-testing and validation) of an international project to develop a stand-alone measure of spiritual well-being (SWB) for palliative cancer patients. Participants (n = 451)-from 14 countries on four continents; 54% female; 188 Christian; 50 Muslim; 156 with no religion-completed a provisional 36-item measure of SWB plus the EORTC QLQ-C15-PAL (PAL), then took part in a structured debriefing interview. All items showed good score distribution across response categories. We assessed scale structure using principal component analysis and Rasch analysis, and explored construct validity, and convergent/divergent validity with the PAL. Twenty-two items in four scoring scales (Relationship with Self, Relationships with Others, Relationship with Someone or Something Greater, and Existential) explained 53% of the variance. The measure also includes a global SWB item and nine other items. Scores on the PAL global quality-of-life item and Emotional Functioning scale weakly-moderately correlated with scores on the global SWB item and two of the four SWB scales. This new validated 32-item SWB measure addresses a distinct aspect of quality-of-life, and is now available for use in research and clinical practice, with a role as both a measurement and an intervention tool.

Impact of intensity and timing of integrated home palliative cancer care on end-of-life hospitalization in Northern Italy.

PURPOSE: The Veneto Region implemented a novel integrated home-based palliative cancer care (HPCC) program embedded in primary care. We examined the impact of timing and intensity of this program on the quality of end-of-life (EOL) care. METHODS: We selected adult cancer patients died in the Veneto Region between March and December 2013, excluding those died from haematological malignancies as well as the very elderly (85+ years). We retrieved the claim-based data on hospitalization and homecare visits, and defined two observation windows: 90 to 16 days before death to examine intensity of HPCC exposure, and the last 15 days of life to examine EOL outcomes, including hospital death, any hospital stay for medical reasons and hospital stay ≥7 days for medical reasons. Multivariate analysis was conducted using a Poisson model. RESULTS: Among the 2211 adults who died of solid tumours and received 1+ homecare visits during the exposure period, 1077 (48.7%), 552 (25.0%) and 582 (26.3%) had 0.1-1.9, 2-3.9 and 4+ homecare visits/week, respectively. The median duration between an HPCC home visit and death was 92 days (IQR 42-257 days). Hospital death occurred in 856 (38.7%) patients, while 1087 (49.2%) and 556 (25.1%) had a hospital stay and a hospital stay ≥7 days during the exposure period, respectively. In the multivariate analysis, a greater intensity of integrated HPCC (4+ visits/week) was significantly associated with a lower risk of hospital death (relative risk [RR] = 0.67, 0.59-0.76), any hospital stay (RR = 0.69, 0.62-0.77) and hospital stay ≥7 days for medical reasons (RR = 0.59, 0.49-0.71). A late activation (≤30 days before death) of HPCC was also associated with increased both hospital stay (RR = 1.26, 0.11-1.42) and hospital stay ≥7 days (RR = 1.25, 1.01-1.54). CONCLUSIONS: A greater HPCC program intensity reduces the risk of hospital death and hospital stay in the end-of-life. An early activation of this program can contribute to improve these EOL outcomes.

Validity and reliability of the MSKCC Bowel Function instrument in a sample of Italian rectal cancer patients.

AIMS: The purpose of this study was to translate the Memorial Sloan Kettering Cancer Centre (MSKCC) Bowel Function Instrument into Italian and to test its psychometric validity and reliability in a sample of Italian rectal cancer patients. METHODS: The MSKCC questionnaire was translated into Italian using a standard procedure of double-back translation. Construct validity was tested using a factor analysis and internal reliability was estimated using the Cronbach's alpha coefficient. Concurrent validity was determined by correlations with European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 quality of life scales. A non-parametric analysis of variance was used to establish the discriminant validity of the questionnaire. Test-retest reliability was assessed using the intra-class correlation coefficient. RESULTS: 124 rectal cancer patients participated in the validation study. The number of missing items was 2.2%. The factorial structure was found to be quite similar to the original one and the internal reliability was 0.7 for urgency, 0.6 for frequency, and 0.7 for dietary subscale. The test-retest reliability was acceptable with one exception: the dietary subscale showed a low reproducibility (ICC = 0.4). All three subscales showed a significant correlation with the QLQ-C30 and QLQ-CR38 domains and were able to discriminate several groups of clinical relevance. CONCLUSIONS: The Italian version of the MSKCC Bowel Function Instrument shows acceptable psychometric properties and can be considered a valuable and specific instrument to assess bowel functions in rectal cancer patients, both for research purposes and in clinical practise.

Complications, functional outcome and quality of life after intensive preoperative chemoradiotherapy for rectal cancer.

AIMS: To investigate early and late complications in 44 patients with locally advanced mid-low rectal cancer enrolled in a phase I-II study, who had received an aggressive chemoradiation treatment (50.4Gy/28F; 5-FU continuous infusion and weekly Oxaliplatin) followed by total mesorectal excision and 5-FU based postoperative chemotherapy. The aim of the present study is also to evaluate functional outcome and quality of life (QoL) in a sub-group of 22 patients. METHODS: Standardized forms for early and late surgical complications were completed for all patients. Anorectal function and QoL were also investigated in 22 patients who underwent surgery in the same surgical unit, using the fecal incontinence scoring system (FIS) and EORTC-QLQ-CR38 questionnaires, compiled before and after radiotherapy and at least 8 months after surgery. The differences over time in scores were analyzed using repeated measure ANOVA. RESULTS: The median age of patients (25 males and 19 females) was 58 (range: 34-73) years. A low anterior resection was performed in 39 cases, radical resection in 41, and 12 patients had a pathological complete response. There were no operative deaths; 4 and 9 patients required re-operation for early and late complications, respectively. FIS score did not present a significant worsening over time. According to data in the EORTC-QLQ-CR38 questionnaire, a significant improvement over time was found only for "future perspective". CONCLUSION: Our findings seem to indicate that this aggressive 5-FU-Oxalipaltin-based treatment implies no impairment of QoL and anorectal function, even if a high rate of late major complications was observed. Studies on larger series are required to confirm these results.

Infecçäo por Clonorchis sinensis em imigrantes asiáticos no Brasil: tratamento com praziquantel / Clonorchis sinensis infections in Asian immigrants in Brazil: treatment with praziquantel

Estudaram-se quinze pacientes com infecçäo assintomática por Clonorchis sinensis, revelada através de exame parasitológico de fezes. Todos eram de origem asiática e procuraram o Laboratório Central do Instituto Adolfo Lutz para se submeterem a exames laboratoriais necessários a regularizaçäo de sua situaçäo, face a nova legislaçäo sobre imigrantes. Eram todos indivíduos adultos, seis pertencendo ao sexo feminino e nove ao masculino. Os quinze pacientes comn clonorquíase foram internados no Hospital das Clínicas da FMUSP e tratados com Praziquantel, na dosagem de 60 mg/Kg de peso corporal, dividida em duas tomadas. Foram realizados exames coprológicos quantitativos (método de Kato-Katz), antes do tratamento específico e no 15§, 30§ e 60§ dias após a terapêutica. Na última avaliaçäo (60§ dias após terapêutica), em nove pacientes (60,0%) näo se encontraram ovos do treamatódeo nas fezes e nos seis (40,0%), que continuavam eliminando ovos, notou-se reduçäo na quantidade eliminada (superior a 90% em cinco e a 30% no paciente restante). Os pacientes foram também submetidos a exames subsidiários, para avaliaçäo do estado geral e funçäo hepática, antes da administraçäo de Praziquantel e, posteriormente, no seguimento ambulatorial. A medicaçäo foi relativamente bem tolerada pelos pacientes, verificando-se a ocorrência de efeitos colaterais representados por náuseas e vômitos (dois casos), vertigens e tonturas (dois casos), epigastralgia (dois casos) e diarréia no 3§ dia após tratamento (um caso)

[Infection by Clonorchis sinensis in Asian immigrants in Brazil. Treatment with praziquantel]. / Infecção por Clonorchis sinensis em imigrantes asiáticos no Brasil. Tratamento com praziquantel.

Fifteen adult patients with assymptomatic infection due to Clonorchis sinensis, diagnosed by coprological examination, were studied. They all came from Asia (twelve from Taiwan, two from South Korea and one from Hong Kong) and were examined at the Adolfo Lutz Institute and the Department of Infectious Diseases, School of Medicine, University of São Paulo, in São Paulo, Brazil. Six patients were women and nine men. All studied patients were admitted to hospital and treated with praziquantel (60 mg/kg). Previous to treatment and on the 15th, 30th and 60th days after praziquantel administration, patients were submitted to quantitative stool examinations, according to Kato-Katz's technique and to hematological and biochemical serum analysis. After a 60 day follow-up nine patients (60%) were negative for C. sinensis eggs in stools. Those not cured after praziquantel administration (six patients, 40%) revealed a sharp decline in faecal elimination of C. sinensis eggs.