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Objective: Demoralization is a commonly observed syndrome in cancer patients, deserving to be carefully assessed in cross-cultural contexts.Aims: To examine the factor structure and concurrent and divergent validity of the Italian version of the Demoralization Scale (DS-IT) in cancer patients.Methods: The sample included 194 Italian cancer outpatients who were assessed by using the DS-IT and the Diagnostic Criteria of Psychosomatic Research-Demoralization module to examine demoralization. The Patient Health Questionnaire-9 (PHQ-9) to explore depression and the Mini-Mental Adjustment-to-Cancer-Hopelessness/Helplessness scale (Mini-MAC-HH) to explore maladaptive coping were also administered.Results: Four factors were extracted by exploratory factor analysis on the DS-IT (disheartenment, α = .87; sense of failure, α = .77; dysphoria, α = .73; loss of meaning/purpose, α = .72; total = 0.91), accounting for 57.1% of the variance. The DS-IT factors shared between 17% and 36% of the variance. Patients reporting a diagnosis of demoralization on the Diagnostic Criteria of Psychosomatic Research-Demoralization module (23.7%) had higher scores on DS-IT loss of meaning/purpose, sense of failure, dysphoria, and DS-IT total. About half of those who were highly demoralized were not depressed and among those who had moderate or moderately severe demoralization, about 80% were not depressed on the PHQ-9. The DS-IT was significantly associated with PHQ-9 and Mini-MAC-HH.Conclusions: The study presents further evidence that demoralization is a significant clinical condition and that the DS-IT demonstrates satisfactory levels of validity and reliability to support its use in patients in the ambulatory cancer setting. [ABSTRACT FROM AUTHOR]

Context The Patient Dignity Inventory (PDI) is a valid and reliable instrument to measure dignity, as a state of physical, mental, social, and spiritual well-being in palliative care patients and an essential dimension for a comprehensive patient-centered approach. Objectives We examined the factor structure and correlation of the Italian version of the PDI (PDI-IT) with psychosocial variables among advanced and nonadvanced cancer outpatients in two Italian centers. Methods In a sample of 194 patients, principal component analysis, reliability analysis (Cronbach's coefficient alpha), and correlation analysis of the PDI-IT were performed. Concurrent validity was evaluated with respect to the Italian versions of Patient Health Questionnaire-9 (PHQ-9), as a measure of depression, the Mini-Mental Adjustment to Cancer-Hopelessness Scale, as a measure of dysfunctional coping, and the Demoralization Scale (DS-IT), as a measure of demoralization. Results Three factors were extracted by exploratory factor analysis, which accounted for 64.38% of the variance, namely existential distress (Cronbach's α = 0.95), psychological distress (Cronbach's α = 0.88), and physical distress (Cronbach's α = 0.81), with a Cronbach's α coefficient for the PDI-IT total score of 0.96. PDI-IT factors were significantly intercorrelated and shared between 42% and 53% of the variance. Higher scores on all the PDI-IT factors and PDI-IT total were found among patients who were clinically depressed (PHQ-9) and among those who were demoralized on the DS-IT. Significant correlations were also found between all PDI-IT and the DS-IT, PHQ-9, and the Mini-Mental Adjustment to Cancer-Hopelessness Scale. Conclusions The study confirmed that the PDI-IT is a valid instrument to be applied in oncology and measuring three factors, namely existential, psychological, and physical distress, as core dimensions of dignity, to be monitored and treated in clinical settings. [ABSTRACT FROM AUTHOR]

Objective The aim of the study was to examine awareness of cancer and the relationship with distress and satisfaction with care among Italian cancer patients. Methods Two hundred sixty-two cancer patients consecutively admitted to the Day Hospital of four cancer centers in Italy completed the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30, the EORTC Inpatient Satisfaction-32, the EORTC Information Questionnaire-25, the distress thermometer, the Mini-mental Adjustment to Cancer scale, a visual analogue scale of illness awareness, and questions related to the admission and unmet needs. Results Eighty-seven percent of patients were aware of their diagnosis, but 49% of those with metastatic cancer thought they have a curable disease. About one-third felt that family members often (16%) or always (13%) were hiding information or bad news in order to protect them. In multivariate analysis, the perception of being protected from bad news by the family was associated with the perceived need to talk more with the family but was not associated with demographic or clinical (Karnofsky Performance Status and stage) variables, lower emotional distress, and greater satisfaction with care and information. Also, awareness of diagnosis and prognosis was not associated with demographic or clinical variables, emotional distress, or satisfaction with care and information Conclusions Most cancer patients were fully informed about their diagnosis, although awareness of disease was not coincident with awareness of prognosis and disease progression. Information and knowledge were not destructive of hope and did not increase distress. Family issues are still a significant factor molding openness and sharing of information. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

The aims of the study were to assess sociodemographic and clinical factors associated with suicidal ideation in patients with cancer who required a psycho-oncological support. Among 504 participants, there were 136 (23 men and 113 women) cancer patients who completed psychological assessment when admitted to the Psycho-oncology Outpatient Clinic between 2006 and 2011. Suicidal ideation was assessed by Item 9 of the Brief Symptom Inventory, Hopelessness was assessed by the hopelessness subscale of the Mini-Mental Adjustment to Cancer Scale, and Depression was assessed by the depression subscale of the Hospital and Anxiety Depression Scale. Around 30% of this sample reported affective symptoms and around 20% reported suicidal ideation and hopelessness. Patients who reported suicidal ideation were more hopeless (18.8 ± 6.7 vs. 15.7 ± 5.2; t(134) = 2.54; p < 0.05) and reported more depression (11.8 ± 4.8 vs. 6.8 ± 4.1; t(134) = 5.30; p < 0.001). It is evident that cancer can result in a strong psychological distress in the patient. It is important, therefore, that cancer patients receive a proper assistance and psychological support and that both the possible presence of depression and suicidal ideation are constantly monitored. [ABSTRACT FROM PUBLISHER]

A substantial fraction of protein interactions in the cell is mediated by families of protein modules binding to relatively short linear peptides. Many of these interactions have a high dissociation constant and are therefore suitable for supporting the formation of dynamic complexes that are assembled and disassembled during signal transduction. Extensive work in the past decade has shown that, although member domains within a family have some degree of intrinsic peptide recognition specificity, the derived interaction networks display substantial promiscuity. We review here recent advances in the methods for deriving the portion of the protein network mediated by these domain families and discuss how specific biological outputs could emerge in vivo despite the observed promiscuity in peptide recognition in vitro. [Copyright &y& Elsevier]

Background: The EORTC Quality of Life Group has developed a questionnaire to evaluate cancer patients' perception of their communication with healthcare professionals (HCPs): the EORTC QLQ-COMU26. In this study we test the validity and reliability of this novel measure in an international and culturally diverse sample of cancer patients. Methods: Cancer patients completed the following EORTC questionnaires at two time points (before and during treatment): the QLQ-COMU26 (including a debriefing questionnaire), the QLQ-C30, and specific IN-PATSAT32 scales. These data were used to assess: the cross-cultural applicability, acceptability, scale structure, reliability, convergent/divergent validity, known-groups validity, and responsiveness to change of the QLQ-COMU26. Results: Data were collected from 498 patients with various cancer diagnoses in 10 European countries, Japan, Jordan and India (overall 5 cultural regions). At most, only 3% of patients identified an item as confusing and 0.6% as upsetting, which indicates that the questionnaire was clear and did not trigger negative emotional responses. Confirmatory factor analysis and multi-trait scaling confirmed the hypothesised QLQ-COMU26 scale structure comprising six multi-item scales and four single items (RMSEA = 0.025). Reliability was good for all scales (internal consistency > 0.70; test–retest reliability > 0.85). Convergent validity was supported by correlations of ≥ 0.50 with related scales of the IN-PATSAT32 and correlations < 0.30 with unrelated QLQ-C30 scales. Known-groups validity was shown according to sex, education, levels of anxiety and depression, satisfaction with communication, disease stage and treatment intention, professional evaluated, and having a companion during the visit. The QLQ-COMU26 captured changes over time in groups that were defined based on changes in the item of satisfaction with communication. Conclusion: The EORTC QLQ-COMU26 is a reliable and valid measure of patients' perceptions of their communication with HCPs. The EORTC QLQ-COMU26 can be used in daily clinical practice and research and in various cancer patient groups from different cultures. This questionnaire can help to improve communication between patients and healthcare professionals. [ABSTRACT FROM AUTHOR]

Objectives: Sexuality is an important dimension of health-related quality of life (HRQOL) in cancer patients. Studies evidence that most patients report impairments of their sexual health related to their disease or its treatment. The Quality of Life Group of the European Organization for the Research and Treatment of Cancer (EORTC) developed a patient reported outcome measure assessing multidimensional aspects of sexual health. The validation study for this instrument revealed heterogenous results for patients in palliative oncological treatment. The aim of this secondary analyses is to examine differences in patient related sexual health outcomes between palliative patients with good performance status (GPS) and those with poor performance status (PPS). Methods: In this observational cohort study, self-reported sexual health issue scores were compared between the two groups of patients in palliative oncological treatment with GPS vs PPS status. Results: Patients with GPS experienced significantly more sexual satisfaction than patients with PPS (p = 0.015). They reported significantly more treatment effects on their sexual activity (p = 0.005) and suffer more from decreased libido (p = 0.008). Patients with PPS reported significantly more fatigue (p = 0.03) and regarded preservation of sexual activity of higher importance than did patients with GPS (p = 0.049). Conclusions: Our study demonstrates the importance of sexuality for patients in palliative oncological treatment, especially for those with limited performance status. Considering the patients´ perspective, sexual health reaches beyond physical functioning. Patients in a palliative phase of disease report high levels of psychosexual problems while sexual performance deteriorates. Sexuality is an important aspect of HRQOL for these patients, needs to be addressed by health care providers and sensitively integrated into palliative care plans. [ABSTRACT FROM AUTHOR]

Chemotherapy side effects ( CSE) have a strong impact on patients' quality of life ( QOL). To assess patient perceptions of CSE, their impact on QOL and doctor-patient communication regarding these aspects, a survey was conducted among Italian cancer patients. Patients at least 18 years of age, who received chemotherapy, were administered a dedicated questionnaire to assess their point of view on five domains: expectations about CSE and impact on QOL; doctor-patient communication about CSE; treatments to reduce the impact of CSE; sexual life; family relationships/activities and employment. A total of 761 patients participated. CSE had a considerable impact on patient QOL. Nausea/vomiting was the most feared adverse effect before initiating chemotherapy and the one most commonly experienced during treatment. Patients generally reported good doctor-patient communication regarding information about CSE. In almost all cases, the oncologists prescribed an antiemetic treatment, but the incidence of nausea/vomiting was high. Cancer and CSE severely affected sexual life, daily activities and employment. CSE had a strong negative impact on QOL. Good doctor-patient communication is essential. Improving antiemetic strategies may improve QOL. Doctors' ability to inform patients about delicate issues, such as the impact of CSE on sexual life, needs to be improved. [ABSTRACT FROM AUTHOR]

With regard to doctors' interpersonal skills and availability, patients with breast, colorectal and esophageal cancer were less satisfied than patients with lung and head and neck cancer in the multivariate analyses. 0--- ht 1 I N i , number of patients included in the study; I N i invited, number of patients invited per country; Attrition rate, percentage of patients per country who declined to participate. Keywords: cancer; communication; cross-cultural; oncology; psycho-oncology; satisfaction with care EN cancer communication cross-cultural oncology psycho-oncology satisfaction with care 541 547 7 03/11/22 20220301 NES 220301 Key points Patient satisfaction with communication with professionals has been found to be an important endpoint in cancer treatment, especially in studies evaluating routine Patient Reported Outcomes (PRO) monitoring. The greater SC among patients who receive treatment with palliative intention (chemo- and/or radiotherapy) suggests that more attention is given to communication with patients in non-curative treatment. [Extracted from the article]

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale,.80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from.70 to.93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice. • The validation study confirmed the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Sexual Health (QLQ-SH22). • The instrument is clinically applicable and valid. • The QLQ-SH22 can be used in clinical practice as well as in survivorship research. • The tool is available in 10 languages and can be obtained via the EORTC website. [ABSTRACT FROM AUTHOR]

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed computerised adaptive tests (CATs) for the 14 functional and symptom domains of the EORTC QLQ-C30 quality of life questionnaire. This is expected to optimise measurement precision, relevance to patients and flexibility. Here, we present the first international validation of the EORTC CAT Core.Methods: A heterogeneous sample of 699 cancer patients scheduled for chemotherapy and/or radiotherapy was recruited across seven European countries. The EORTC CAT Core and all QLQ-C30 items were administered to participants before and after initiating treatment. Correlations between CAT and QLQ-C30 scores and floor/ceiling effects were calculated. Using several grouping variables, relative validity (cross-sectional known groups difference), responsiveness (changes over time) and relative sample size requirements of the CAT compared to the QLQ-C30 were estimated.Results: Correlations of the CAT and QLQ-C30 ranged from 0.81 to 0.93 across domains. The mean relative reduction in floor and ceiling effects using the CAT was 42% (range 3-99%). Analyses of known groups validity and responsiveness indicated that, across domains, mean sample size requirements for the CAT were 72% and 70%, respectively, of those using the QLQ-C30.Conclusions: The EORTC CAT Core measures the same domains as the QLQ-C30 with reduced floor/ceiling effects. The CAT generally facilitated the use of smaller samples (about 30% smaller on average) without loss of power compared to the QLQ-C30. Based on this study, the EORTC QLG will release the EORTC CAT Core for general use. [ABSTRACT FROM AUTHOR]

Background To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains. Methods The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed. Results Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7–34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20–35% on average without loss of power. Conclusions The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients. [ABSTRACT FROM AUTHOR]

Abstract: To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ‐22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in‐depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross‐cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22‐item short questionnaire resulted in a change of wording in five items and two communication‐related items; no items were removed. Preliminary psychometric analysis revealed a two‐factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross‐cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large‐scale, cross‐cultural field testing of the EORTC SHQ‐22, has commenced. [ABSTRACT FROM AUTHOR]

Aim The aim of this study is to explore the possible effects of clinical and cultural characteristics of hepatocellular carcinoma on patients' health-related quality of life (HRQoL). Methods Patients with hepatocellular carcinoma from Asian and European countries completed the EORTC QLQ-C30 and the EORTC QLQ-HCC18. Comparisons were made using Student's t-test and Wilcoxon rank-sum test with method of false discovery to correct multiple comparisons. Multiway analysis of variance and model selection were used to assess the effects of clinical characteristics and geographic areas. Results Two hundred and twenty-seven patients with hepatocellular carcinoma completed questionnaires. After adjusting for demographic and clinical characteristics, Asian patients still had significantly better HRQoL scores in emotional functioning, insomnia, (QLQ-C30) and in sexual interest (QLQ-HCC18). We also found an interaction in physical functioning (QLQ-C30) and fatigue (QLQ-HCC18) between geographic region and marital status, married European had worse HRQoL scores than Asian singles. Conclusions Both clinical characteristics and geographic areas affected the HRQoL in with hepatocellular carcinoma. Cultural differences and clinical differences in the pattern of disease due to active surveillance of Asian countries may explain the results. [ABSTRACT FROM AUTHOR]

Purpose: Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals.Methods: Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed.Results: One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items.Conclusions: The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients. [ABSTRACT FROM AUTHOR]

The article reports on steps taken to produce a satisfaction with cancer care core questionnaire for both the inpatient and outpatient care settings and a complementary cancer outpatient satisfaction with care module. Topics discussed include issues for outpatient care domains that were not addressed sufficiently by the questionnaire and operationalization of issues into questionnaire items.

Background: Role functioning (RF) as a core construct of health-related quality of life (HRQOL) comprises aspects of occupational and social roles relevant for patients in all treatment phases as well as for survivors. The objective of the current study was to improve its assessment by developing a computer-adaptive test (CAT) for RF. This was part of a larger project whose objective is to develop a CAT version of the EORTC QLQ-C30 which is one of the most widely used HRQOL instruments in oncology.Methods: In accordance with EORTC guidelines, the development of the RF-CAT comprised four phases. Phase I involved the conceptualization of RF. In Phase II, a provisional list of items was defined and revised by experts in the field. In phase III, feedback was obtained from cancer patients in various countries. Phase IV comprised field testing in an international sample, calibration of the item bank, and evaluation of the psychometric performance of the RF-CAT.Results: Phases I-III yielded a list of 12 items eligible for phase IV field-testing. The field-testing sample included 1,023 patients from Austria, Denmark, Italy, and the UK. Psychometric evaluation and item response theory analyses yielded 10 items with good psychometric properties. The resulting item bank exhibits excellent reliability (mean reliability = 0.85, median = 0.95). Using the RF-CAT may allow sample size savings from 11 % up to 50 % compared to using the QLQ-C30 RF scale.Conclusions: The RF-CAT item bank improves the precision and efficiency with which RF can be assessed, promoting its integration into oncology research and clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: Patient-reported outcomes should ideally be adapted to the individual patient while maintaining comparability of scores across patients. This is achievable using computerized adaptive testing (CAT). The aim here was to develop an item bank for CAT measurement of the pain domain as measured by the EORTC QLQ-C30 questionnaire.Methods: The development process consisted of four steps: (1) literature search, (2) formulation of new items and expert evaluations, (3) pretesting and (4) field-testing and psychometric analyses for the final selection of items.Results: In step 1, we identified 337 pain items from the literature. Twenty-nine new items fitting the QLQ-C30 item style were formulated in step 2 that were reduced to 26 items by expert evaluations. Based on interviews with 31 patients from Denmark, France and the UK, the list was further reduced to 21 items in step 3. In phase 4, responses were obtained from 1103 cancer patients from five countries. Psychometric evaluations showed that 16 items could be retained in a unidimensional item bank. Evaluations indicated that use of the CAT measure may reduce sample size requirements with 15-25% compared to using the QLQ-C30 pain scale.Conclusions: We have established an item bank of 16 items suitable for CAT measurement of pain. While being backward compatible with the QLQ-C30, the new item bank will significantly improve measurement precision of pain. We recommend initiating CAT measurement by screening for pain using the two original QLQ-C30 pain items. The EORTC pain CAT is currently available for "experimental" purposes. [ABSTRACT FROM AUTHOR]

Purpose: Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death worldwide. One of the primary treatment goals for incurable advanced cases is to prolong quality of life (QoL). Thus, to determine which HCC therapies may be linked to a more favorable QoL, we assessed the association between QoL changes and different treatments in HCC patients. Methods: We analyzed a non-randomized multicenter longitudinal study, which included 171 patients treated with surgery ( n = 53), ablation ( n = 53) or embolization ( n = 65) from seven centers: four Asian and three European sites. All participants completed the EORTC QLQ-C30 and QLQ-HCC18 questionnaires before and after treatment. Propensity scores were calculated and used in addition to race for adjustment in the logistic regression model to account for the confounding effects of patient characteristics including age, gender, race, employment, living with family, at least one comorbid condition, years since diagnosis, prior treatment history, BCLC stage, Child-Pugh grade, cirrhosis, bilirubin levels and QoL score before treatment. Results: After adjustment for confounders, patients tended to have higher odds of QoL deterioration when treated with ablation versus embolization (dyspnea: p = 0.019; appetite loss: p = 0.018; body image: p = 0.035) or ablation versus surgery (dyspnea: p = 0.099; appetite loss: p = 0.100; body image: p = 0.038). Conclusions: There were significant differences in QoL deterioration across different treatment groups. This information may assist patients and providers when selecting patient-centered treatment approaches for HCC. [ABSTRACT FROM AUTHOR]

Purpose: A significant proportion of oncological patients experiences lack of appetite. Precise measurement is relevant to improve the management of lack of appetite. The so-called computer-adaptive test (CAT) allows for adaptation of the questionnaire to the individual patient, thereby optimizing measurement precision. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30 questionnaire. Here, we report on the development of the lack of appetite CAT. Methods: The EORTC approach to CAT development comprises four phases: literature search, operationalization, pre-testing, and field testing. Phases 1-3 are described in this paper. First, a list of items was retrieved from the literature. This was refined, deleting redundant and irrelevant items. Next, new items fitting the 'QLQ-C30 item style' were created. These were evaluated by international samples of experts and cancer patients. Results: The literature search generated a list of 146 items. After a comprehensive item selection procedure, the list was reduced to 24 items. These formed the basis for 21 new items fitting the QLQ-C30 item style. Expert evaluations ( n = 10) and patient interviews ( n = 49) reduced the list to 12 lack of appetite items. Conclusions: Phases 1-3 resulted in 12 lack of appetite candidate items. Based on a field testing (phase 4), the psychometric characteristics of the items will be assessed and the final item bank will be generated. This CAT item bank is expected to provide precise and efficient measurement of lack of appetite while still being backward compatible to the original QLQ-C30 scale. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented which discusses the communication and relationship between cancer patients and professional.

Background The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is currently developing computerized adaptive testing measures for the Quality of Life Questionnaire Core-30 (QLQ-C30) scales. The work presented here describes the development of an EORTC item bank for emotional functioning (EF), which is one of the core domains of the QLQ-C30. Methods According to the EORTC guidelines on module development, the development of the EF item bank comprised four phases, of which the phases I-III are reported in the present paper. Phase I involved defining the theoretical framework for the EF item bank and a literature search. Phase II included pre-defined item selection steps and a multi-stage expert review process. In phase III, feedback from cancer patients from different countries was obtained. Results On the basis of literature search in phase I, a list of 1750 items was generated. These were reviewed and further developed in phase II with a focus on relevance, redundancy, clarity, and difficulty. The development and selection steps led to a preliminary list of 41 items. In phase III, patient interviews ( N = 41; Austria, Denmark, Italy, and the UK) were conducted with the preliminary item list, resulting in some minor changes to item wording. The final list comprised 38 items. Discussion The phases I-III of the developmental process have resulted in an EF item list that was well accepted by patients in several countries. The items will be subjected to larger-scale field testing in order to establish their psychometric characteristics and their fit to an item response theory model. © 2013 The Authors. Psycho-Oncology published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

We investigated the hypothesis that patients developing high-grade erythema of the breast skin during radiation treatment could be more likely to present increased levels of proinflammatory cytokines whichmay lead, in turn, to associated fatigue. Forty women with early stage breast cancer who received adjuvant radiotherapy were enrolled from 2007 to 2010. Fatigue symptoms, erythema, and cytokine levels (IL-1β, IL-2, IL6, IL-8, TNF-α, and MCP-1) were registered at baseline, during treatment, and after radiotherapy completion. Seven (17.5%) patients presented fatiguewithout associated depression/anxiety. Grade ⩾2 erythemawas observed in 5 of these 7 patients. IL-1β, IL-2, IL-6, and TNF-α were statistically increased 4 weeks after radiotherapy (P < 0.05). After the Heckman two-step analysis, a statistically significant influence of skin erythema on proinflammatory markers increase (P = 0.00001) was recorded; in the second step, these blood markers showed a significant impact on fatigue (P = 0.026). A seeming increase of fatigue, erythema, and proinflammatory markers was observed between the fourth and the fifth week of treatment followed by a decrease after RT.There were no significant effects of hormone therapy, breast volume, and anemia on fatigue. Our study seems to suggest that fatigue is related to high-grade breast skin erythema during radiotherapy through the increase of cytokines levels. [ABSTRACT FROM AUTHOR]

BACKGROUND: Routine screening for distress is internationally recommended as a necessary standard for good cancer care, given its high prevalence and negative consequences on quality of life. The objective of the current study was to contribute to the Italian validation of the Distress Thermometer (DT) to determine whether the single item DT compared favorably with referent criterion measures. METHODS: In total, 1108 outpatients with cancer were recruited from 38 representative oncology centers in Italy. Each participant completed the DT and a list of 34 possible cancer-related problems (the Problem List), the Hospital Anxiety and Depression Scale (HADS), the 18-item Brief Symptom Inventory (BSI-18), and a short visual analog scale to determine the understandability of the tools. RESULTS: Receiver operating characteristic analysis revealed that DT cutoff scores ≥4 and ≥5 had optimal sensitivity and specificity relative to both HADS and BSI-18 cutoff scores for general caseness and more severe psychological distress, respectively. Patients with DT scores ≥4 (cases) were more likely to be women; to have had psychological problems in the past; to report more stressful events in the last year; and to currently have more family, emotional, and physical problems related to cancer or cancer treatment. Patients indicated that the DT was easier to fill out and to understand than the HADS, but not the BSI-18. CONCLUSIONS: The DT was identified as a simple and effective screening instrument for detecting distress in Italian cancer patients as a first step toward more properly referring those in need to psychosocial intervention. Cancer 2013. © 2013 American Cancer Society. [ABSTRACT FROM AUTHOR]

The article discusses a study to evaluate the cross-cultural development of a stand-alone European Organization for Research and Treatment of Cancer (EORTC) measure of spiritual well being for palliative care patients with cancer. The study found that a provisional 36-item measure ready for Phase IV field-testing, the EORTC QLQ-SWB36 has been developed, with the items are comprehensible across languages and cultures. The need for Phase IV testing is highlighted.

Objectives: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing a computer- adaptive test (CAT) version of the EORTC Quality of Life Questionnaire (QLQ-C30). We evaluated the measurement properties of the CAT versions of physical functioning (PF) and fatigue (FA) and compared these with the corresponding QLQ-C30 scales. Study Design and Setting: Based on international samples of more than 1,000 cancer patients, we simulated CAT administration of varying numbers of items and compared the resulting scores with those based on all items in the respective item pools. Furthermore, the relative validity (RV) of CATs was compared with that of the QLQ-C30 scales using known groups validity. Results: For both dimensions, CATs of all lengths resulted in unbiased score estimates. CATs consisting of five or more items had reliability>0.90, correlated ≥97 with the full scale, and had root mean square error <0.25. The average RVs for these CATs ranged 1.02-1.33, indicating possible savings in sample size requirements of 3-42% using CAT. Conclusion: The CAT versions of PF and FA exhibited high levels of measurement precision and efficiency. The potential savings in sample size requirements using CATs compared with those using the original QLQ-C30 scales were typically 20% or more. 2013 Elsevier Inc. All rights reserved. [ABSTRACT FROM AUTHOR]

Objective Informational needs among cancer patients are similar, but the degree of information disclosure in different cultural areas varies. In this paper, we present the results of a cross-cultural study on information received. Methods The EORTC information questionnaire, EORTC QLQ-INFO25, was administered during the treatment process. This questionnaire evaluates the information that patients report they have received. Cross-cultural differences in information have been evaluated using statistical tests such as Kruskall-Wallis and multivariate models with covariates to account for differences in clinical and demographic characteristics across areas. Results Four hundred and fifty-one patients from three cultural areas, North-Middle Europe, South Europe, and Taiwan, were included in the study. Significant differences among the three cultural areas appeared in eight QLQ-INFO25 dimensions: information about the disease; medical tests; places of care; written information; information on CD/tape/video; satisfaction; wish for more information; and information helpfulness. North-Middle Europe patients received more written information (mean = 67.2 (North) and 33.8 (South)) and South Europe patients received more information on different places of care (mean = 24.7 (North) and 35.0 (South)). Patients from North-Middle Europe and South Europe received more information than patients from Taiwan about the disease (mean = 57.9, 60.6, and 47.1, respectively) and medical tests (70.9, 70.4, and 54.5), showed more satisfaction (64.8, 70.2, and 35.0), and considered the information more helpful (71.9, 73.9, and 50.4). These results were confirmed when adjusting for age, education, and disease stage. Conclusion There are cross-cultural differences in information received. Some of these differences are based on the characteristics of each culture. Copyright © 2011 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Purpose: Computerized adaptive test (CAT) methods, based on item response theory (IRT), enable a patient-reported outcome instrument to be adapted to the individual patient while maintaining direct comparability of scores. The EORTC Quality of Life Group is developing a CAT version of the widely used EORTC QLQ-C30. We present the development and psychometric validation of the item pool for the first of the scales, physical functioning (PF). Methods: Initial developments (including literature search and patient and expert evaluations) resulted in 56 candidate items. Responses to these items were collected from 1,176 patients with cancer from Denmark, France, Germany, Italy, Taiwan, and the United Kingdom. The items were evaluated with regard to psychometric properties. Results: Evaluations showed that 31 of the items could be included in a unidimensional IRT model with acceptable fit and good content coverage, although the pool may lack items at the upper extreme (good PF). There were several findings of significant differential item functioning (DIF). However, the DIF findings appeared to have little impact on the PF estimation. Conclusions: We have established an item pool for CAT measurement of PF and believe that this CAT instrument will clearly improve the EORTC measurement of PF. [ABSTRACT FROM AUTHOR]

Aim: A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. Methods: Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. Results: Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbach’s alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). Conclusion: The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials. [Copyright &y& Elsevier]

Abstract: Aim: The EORTC Quality of Life (QOL) Group has developed an instrument to evaluate the information received by cancer patients. This study assessed the psychometric characteristics of the EORTC INFO module in a large international/multi-cultural sample of cancer patients. Methods: The provisional 26-item information module (EORTC INFO26) was administered with the EORTC QLQ-C30 and the information scales of the inpatient satisfaction module EORTC IN-PATSAT32 on two occasions during the patients’ treatment and follow-up period. Questionnaire-hypothesised scale structure, reliability, validity and responsiveness to changes were evaluated through standard psychometric analyses. Patient acceptability was assessed with a debriefing questionnaire. Results: The study comprised 509 patients from 8 countries (7 European countries and Taiwan) with different cancers and disease stages. Multi-trait scaling analysis led to the deletion of one item but confirmed the hypothesised 4 multi-item scales (information about disease, medical tests, treatment and other services) and eight single items. Internal consistency for all scales was good (α >0.70), as was test–retest reliability (intraclass correlations>0.70). All items can be combined to generate a single score (α >0.90). Convergent validity was supported by significant correlations with related areas of IN-PATSAT32 (r >0.40). Low correlations with EORTC QLQ-C30 scales confirmed divergent validity (r <0.30) The EORTC INFO-25 module discriminated among groups based on gender, age, education, levels of anxiety and depression, information wishes and satisfaction. Only one scale captured changes over time. Conclusions: The EORTC QLQ-INFO 25 is a reliable and valid self-reported instrument. The module can be used in cross-cultural observational and intervention studies. [Copyright &y& Elsevier]

Background: Health-related quality of life (HRQOL) questionnaires should ideally be adapted to the individual patient and at the same time scores should be directly comparable across patients. This is achievable using a computerised adaptive test (CAT). Basing the CAT on an existing instrument enables measurement within an established HRQOL framework and allows backward-compatibility with studies using the original instrument. Because of these advantages the EORTC Quality of Life Group (QLG) has initiated a project to develop a CAT version of the widely used EORTC QLQ-C30. Methods: We present the EORTC QLG’s strategy for developing a CAT. For each dimension of the EORTC QLQ-C30 our approach includes literature search and conceptualisation, formulation of new items, expert and patient evaluations, field-testing, and psychometric analyses of the items. The strategy is illustrated with the initial results of the development of CAT for physical functioning (PF). Results: We identified 975 PF items in the literature. Of these, 407 items were deemed relevant, i.e. measured one of the PF aspects measured by the QLQ-C30. Based on these items we developed 86 new items. Review by the EORTC CAT-project group reduced this to 66 items. Based on expert and patient evaluations several items were revised and the list was further reduced to 51 items. Conclusions: Based on the findings for PF, we believe that our approach will generate item pools that are relevant and appropriate for cancer patients. These will form the basis for a backward-compatible CAT assessing the HRQOL dimensions of the EORTC QLQ-C30. [Copyright &y& Elsevier]

Objective: The EORTC QOL Group has recently completed the cross‐cultural development and validation of a standalone measure of spiritual well‐being (SWB) for cancer patients receiving palliative care: the EORTC QLQ‐SWB32. The measure includes four scales: Relationships with Others, Relationship with Self, Relationship with Someone or Something Greater, and Existential, plus a Global‐SWB item. This paper reports on further research investigating relationships between sex, age and SWB for patients receiving palliative care for cancer—adjusting for other socio‐demographic, clinical and function variables, including WHO performance status and EORTC QLQ‐C15‐PAL emotional and physical function scores. Methods: Cross‐sectional data from the validation study were used, and chi‐square, independent t tests, Mann–Whitney U tests and multiple regression analyses applied. Results: The study included 451 participants with advanced and incurable cancer, from 14 countries. Adjusted analyses found better scores for female participants than males on three of the four EORTC QLQ‐SWB32 subscales; Relationship with others, Relationship with Someone or Something Greater and Existential plus Global‐SWB. Older age was positively associated with better Relationship with Self. Conclusion: The findings from our participants suggest that it might be beneficial if healthcare providers seeking to address patients' spiritual needs pay particular attention to male patients, younger patients and those with poor emotional functioning. [ABSTRACT FROM AUTHOR]

Backround: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used.Methods: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors.Results: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment.Conclusions: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment. [ABSTRACT FROM AUTHOR]