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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., (© 2024. The Author(s).)

Background: 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., Methods: 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., Results: 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., Conclusion: 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., Competing Interests: Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

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.

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., (© 2019 The Authors. European Journal of Cancer Care published by John Wiley & Sons Ltd.)

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., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

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., (© 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

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., (Copyright © 2017 John Wiley & Sons, Ltd.)

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., (© 2016 John Wiley & Sons Ltd.)

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., (Copyright © 2016. Published by Elsevier Inc.)

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.

Objective: To improve measurement precision, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing an item bank for computerized adaptive testing (CAT) of emotional functioning (EF). The item bank will be within the conceptual framework of the widely used EORTC Quality of Life questionnaire (QLQ-C30)., Study Design and Setting: On the basis of literature search and evaluations by international samples of experts and cancer patients, 38 candidate items were developed. The psychometric properties of the items were evaluated in a large international sample of cancer patients. This included evaluations of dimensionality, item response theory (IRT) model fit, differential item functioning (DIF), and of measurement precision/statistical power., Results: Responses were obtained from 1,023 cancer patients from four countries. The evaluations showed that 24 items could be included in a unidimensional IRT model. DIF did not seem to have any significant impact on the estimation of EF. Evaluations indicated that the CAT measure may reduce sample size requirements by up to 50% compared to the QLQ-C30 EF scale without reducing power., Conclusion: On the basis of thorough psychometric evaluations, we have established an EF item bank of 24 items. This will allow for more precise and flexible measurement of EF, while maintaining backward compatibility with the QLQ-C30 EF scale., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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.)

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.

Films that feature characters with cancer have become a familiar sight for movie-goers. 148 movies treating tumors were selected, produced all over the world since the Thirties, in which cancer had "prompt", "relevant", or "plot" character. In order to clearly understand each film's peculiar message about cancer, we recollected data such as genealogy, year and country of production, main characters' age and gender, and kind of tumor. Movies deal with cancer through very relevant questions, as well as themes and contexts that have great influence on oncologist's mind and consciousness. Specially in recent years, films have tackled some of the most important issues around cancer, such as his epidemiology and environmental causes; the economic implications of therapies; the management of symptoms and side effects; the psychological dynamics; the care toward the ending of life. The most frequent treatment mentioned in the movies was chemotherapy followed by antalgic therapy. Very often the ill person on the screen doesn't get over the disease and his death is somehow useful to the plot's outcome. This pattern is so strongly standardized that it persists in spite of real progress of treatments. Movies use disease, and other tragedies, as a dramatic device, and since drama is what we expect of the medium, should we be concerned that there is a gap between fiction and reality? Movies represent an essential step of educational process, but their potential has been fully exploited only in recent times. By watching movies on cancer, oncologists could become more conscious of problems they are already facing in the therapeutic setting: cancer and sexuality, the relationship between the ill person and the medical staff, side effects of therapies. Some films simply make us reflect upon the meaning of life and death. This is useful for the sharing of cancer care, from personal or familiar problems to issues of collective relevance.

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.)

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.

Background: No existing stand-alone measures of spiritual wellbeing have been developed in cross-cultural and multiple linguistic contexts., Aim: Cross-cultural development of a stand-alone European Organisation for Research and Treatment of Cancer (EORTC) measure of spiritual wellbeing for palliative care patients with cancer., Design: Broadly following EORTC Quality of Life Group (QLG) guidelines for developing questionnaires, the study comprised three phases. Phase I identified relevant issues and obtained the views of palliative care patients and professionals about those issues. Phase II operationalised issues into items. Phase III pilot-tested those items with palliative care patients. Amendments to the guidelines included an intermediate Phase IIIa, and debriefing questions specific to the measure., Setting/participants: Phase III pilot-testing recruited 113 people with incurable cancer from hospitals and hospices in six European countries and Japan., Results: A provisional 36-item measure ready for Phase IV field-testing, the EORTC QLQ-SWB36, has been developed. Careful attention to translation and simultaneous development in multiple languages means items are acceptable and consistent between different countries and languages. Phase III data from 113 patients in seven countries show that the items are comprehensible across languages and cultures. Phase III patient participants in several countries used the measure as a starting point for discussing the issues it addresses., Conclusion: The EORTC QLG's rigorous cross-cultural development process ensures that the EORTC QLQ-SWB36 identifies key issues for spiritual wellbeing in multiple cultural contexts, and that items are comprehensible and consistent across languages. Some cross-cultural differences were observed, but data were insufficient to enable generalisation. Phase IV field-testing will investigate these differences further.

Objective: Demoralization and depressive symptoms are very common in chronic organic diseases. The aim of the present study is to evaluate reliability and psychometric properties of the Italian version of the Demoralization Scale (DS) in patients with advanced cancer., Methods: The Italian version of DS was administered to a sample consisting of 100 patients affected by different forms of cancer. The following scales were also administered: Patient Health Questionnaire, Beck Depression Inventory (BDI), Mini-Mental Adjustment to Cancer (MAC) and Karnofsky Performance Status Scale., Results: The total mean score of the DS was 23.9±14.5. The study showed a good degree of stability and internal consistency of DS total score (α=0.90) and the 5 factors represented by loss of meaning and purpose (α=0.69), dysphoria (α=0.72), disheartenment (α=0.84), helplessness (α=0.50) and sense of failure (α=0.74). Significant correlations were found between DS total score and BDI (r=0.74) and between DS factors and BDI (r=0.64 for loss of meaning and purpose; r=0.55 for dysphoria; r=0.71 for disheartenment; r=0.51 for helplessness; r=0.46 for sense of failure). Good correlations were also found between DS total score and Hopelessness scale of MAC (r=0,51). According to different cut-off values, between 28 and 32 patients were seriously demoralized and 40 had moderate levels of demoralization. Between 6 and 20 patients were seriously demoralized but not clinically depressed; between 16 and 31 patients with moderate levels of demoralization had no depression., Conclusion: Results provide further evidence that the DS is a valid and reliable instrument of high clinical relevance in patients with advanced cancer and confirm the hypothesis of the ontological difference between demoralization and depression.

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., (Copyright © 2013 American Cancer Society.)

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.)

The international literature data report that good information and communication are fundamental components of a therapeutic process. They contribute to improve the patient-health care professional relationship, to facilitate doctor-patient relationships, therapeutic compliance and adherence, and to the informed consent in innovative clinical trials. We report the results of a multicentric national initiative that developed a 17-information-structure network: 16 Information Points located in the major state-funded certified cancer centers and general hospitals across Italy and a national Help-line at the nonprofit organization AIMaC (the Italian oncologic patients, families and friends association), and updated the already existing services with the aim to create the National Cancer Information Service (SION). The project is the result of a series of pilot and research projects funded by the Italian Ministry of Health. The Information Service model proposed is based on some fundamental elements: 1) human interaction with experienced operators, adequately trained in communication and information, complemented with 2) virtual interaction (Help line, Internet, blog, forum and social network); 3) informative material adequate for both scientific accuracy and communicative style; 4) adequate locations for appropriate positioning and privacy (adequate visibility); 5) appropriate advertising. First results coming from these initiatives contributed to introduce issues related to "Communication and Information to patients" as a "Public Health Instrument" to the National Cancer Plan approved by the Ministry of Health for the years 2010-2012.

Information is one of the main interventions given to cancer patients. Important research into information disclosure has been conducted and major advances have been made. We present the main theoretical models used to understand the information field and describe the current situation regarding the principal factors related to information: patients' needs, coping strategies, illness representations, cross-cultural differences, the role of the family, and strategies to enhance information giving, such as professional training and patient-targeted interventions. We highlight the need to assess patients' characteristics and desires through questionnaires and interviews and present the European Organisation for Research and Treatment of Cancer Quality of Life Group information questionnaire (EORTC QLQ-INFO 25). This instrument evaluates the level of information patients have received in different areas of their disease, treatment and care, and evaluates qualitative aspects. Finally, we describe the key areas of the information field and discuss how these areas could change in the future.

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 © 2010 Elsevier Ltd. All rights reserved.)

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 (c) 2010 Elsevier Ltd. All rights reserved.)

Background: In many countries, physicians are reluctant to disclose unfavorable medical information to patients with advanced cancer and instead give the bad news to the family., Methods: The authors modified standard communication workshops to help Italian senior oncologists overcome cultural, social, and attitudinal barriers to disclosure of diagnosis and prognosis., Results: Fifty-seven physicians participated; 88% believed the workshops would improve their medical practice. Many pursued further training and organized communication skills programs of their own., Conclusions: Communication skills workshops can be modified to meet educational and social norms and help clinicians acquire the interpersonal skills needed for honest communication with patients.