Acceptability and usefulness of the EORTC 'Write In three Symptoms/Problems' (WISP): a brief open-ended instrument for symptom assessment in cancer patients.

BACKGROUND: The use of open-ended questions supplementing static questionnaires with closed questions may facilitate the recognition of symptoms and toxicities. The open-ended 'Write In three Symptoms/Problems (WISP)' instrument permits patients to report additional symptoms/problems not covered by selected EORTC questionnaires. We evaluated the acceptability and usefulness of WISP with cancer patients receiving active and palliative care/treatment in Austria, Chile, France, Jordan, the Netherlands, Norway, Spain and the United Kingdom. METHODS: We conducted a literature search on validated instruments for cancer patients including open-ended questions and analyzing their responses. WISP was translated into eight languages and pilot tested. WISP translations were pre-tested together with EORTC QLQ-C30, QLQ-C15-PAL and relevant modules, followed by patient interviews to evaluate their understanding about WISP. Proportions were used to summarize patient responses obtained from interviews and WISP. RESULTS: From the seven instruments identified in the literature, only the free text collected from the PRO-CTAE has been analyzed previously. In our study, 161 cancer patients participated in the pre-testing and interviews (50% in active treatment). Qualitative interviews showed high acceptability of WISP. Among the 295 symptoms/problems reported using WISP, skin problems, sore mouth and bleeding were more prevalent in patients in active treatment, whereas numbness/tingling, dry mouth and existential problems were more prevalent in patients in palliative care/treatment. CONCLUSIONS: The EORTC WISP instrument was found to be acceptable and useful for symptom assessment in cancer patients. WISP improves the identification of symptoms/problems not assessed by cancer-generic questionnaires and therefore, we recommend its use alongside the EORTC questionnaires.

Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group.

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However, no high-level recommendations exist to guide users on the design and implementation of these customised PRO measures (item lists) across different PRO measurement systems. To address this issue, a working group was set up, including international stakeholders (academic, independent, industry, health technology assessment, regulatory, and patient advocacy), with the goal of creating recommendations for the use of item libraries in oncology trials. A scoping review was carried out to identify relevant publications and highlight any gaps. Stakeholders commented on the available guidance for each research question, proposed recommendations on how to address gaps in the literature, and came to an agreement using discussion-based methods. Nine primary research questions were identified that formed the scope and structure of the recommendations on how to select items and implement item lists created from item libraries. These recommendations address methods to drive item selection, plan the structure and analysis of item lists, and facilitate their use in conjunction with other measures. The findings resulted in high-level, instrument-agnostic recommendations on the use of item-library-derived item lists in oncology trials.

Healthcare use and healthcare costs for patients with advanced cancer; the international ACTION cluster-randomised trial on advance care planning.

BACKGROUND: Advance care planning supports patients to reflect on and discuss preferences for future treatment and care. Studies of the impact of advance care planning on healthcare use and healthcare costs are scarce. AIM: To determine the impact on healthcare use and costs of an advance care planning intervention across six European countries. DESIGN: Cluster-randomised trial, registered as ISRCTN63110516, of advance care planning conversations supported by certified facilitators. SETTING/PARTICIPANTS: Patients with advanced lung or colorectal cancer from 23 hospitals in Belgium, Denmark, Italy, the Netherlands, Slovenia and the UK. Data on healthcare use were collected from hospital medical files during 12 months after inclusion. RESULTS: Patients with a good performance status were underrepresented in the intervention group (p< 0.001). Intervention and control patients spent on average 9 versus 8 days in hospital (p = 0.07) and the average number of X-rays was 1.9 in both groups. Fewer intervention than control patients received systemic cancer treatment; 79% versus 89%, respectively (p< 0.001). Total average costs of hospital care during 12 months follow-up were €32,700 for intervention versus €40,700 for control patients (p = 0.04 with bootstrap analyses). Multivariable multilevel models showed that lower average costs of care in the intervention group related to differences between study groups in country, religion and WHO-status. No effect of the intervention on differences in costs between study groups was observed (p = 0.3). CONCLUSIONS: Lower care costs as observed in the intervention group were mainly related to patients' characteristics. A definite impact of the intervention itself could not be established.

Process, content, and experiences of delivering the Carer Support Needs Assessment Tool Intervention (CSNAT-I) in the Danish specialised palliative care setting.

PURPOSE: The Carer Support Needs Assessment Tool Intervention (CSNAT-I) has shown positive effects in the Danish specialised palliative care (SPC) setting. Here, we explore the process, content, and experiences of delivering the CSNAT-I. METHODS: Data were collected during a stepped wedge cluster randomised controlled trial investigating the impact of the CSNAT-I in the Danish SPC setting in 2018-2019. Data were obtained from the CSNAT (tool) completed by caregivers, from health care professionals' (HCPs') written documentation of the CSNAT-I, and from semi-structured interviews with HCPs. RESULTS: The study population consisted of the 130 caregivers receiving a first CSNAT-I within 13 days of study enrolment, the 93 caregivers receiving a second CSNAT-I 15-27 days after enrolment, and the 44 HCPs delivering the intervention. Top three domains of unmet caregiver support needs reported in the CSNAT-I were: "knowing what to expect in the future," "dealing with feelings and worries," and "understanding the illness." These domains together with "knowing who to contact if concerned" and "talking to the patient about the illness" were also the domains most frequently prioritised for discussion with HCPs. According to HCPs, most often support delivered directly by HCPs themselves during the actual contact (e.g., listening, advice, information) was sufficient. Overall, HCPs experienced the CSNAT-I as constructive and meaningful, and difficulties in delivering the intervention were rarely an issue. CONCLUSION: The support needs reported by caregivers confirm the relevance of the CSNAT-I. HCPs' overall experiences of the clinical feasibility and relevance of the CSNAT-I were very positive. ClinicalTrials.gov ID: NCT03466580. Date of registration: March 1, 2018.

Bereavement Among Adult Siblings: An Examination of Health Services Utilization and Mental Health Outcomes.

We aimed to examine the association of young and middle-aged sibling bereavement with use of health services and risk of developing mental health disorders over 24 months before and after sibling's death. All persons aged 18-56 years who died of illness/natural causes between 2009 and 2016 were identified in the Danish Register of Causes of Death. The study sample included 31,842 bereaved siblings and 31,842 age- and sex-matched controls. Overall, the largest effect was observed for increased use of psychological services: For women, the peak was observed 4-6 months after the death (odds ratio (OR) = 3.31, 95% confidence interval (CI): 2.85, 3.85) and for men in the first 3 months after the death (OR = 2.63, 95% CI: 2.06, 3.36). The peak of being diagnosed in a hospital setting with any mental disorder for women was observed in the period 13-15 months after sibling death (OR = 1.52, 95% CI: 1.11, 2.07) and for men in the first 3 months after the death (OR = 1.75, 95% CI: 1.32, 2.32). Young and middle-aged adults who experienced the death of a sibling are more likely to use health services and are at risk of poorer mental health outcomes. During the bereavement process, young and middle-aged siblings are especially in need of mental health support, such as professional psychological counseling.

Effect of the Carer Support Needs Assessment Tool intervention (CSNAT-I) in the Danish specialised palliative care setting: a stepped-wedge cluster randomised controlled trial.

BACKGROUND: The Carer Support Needs Assessment Tool intervention (CSNAT-I) has been shown to improve end-of-life care support for informal caregivers. This study investigated the impact of the CSNAT-I on caregivers of patients recently enrolled in specialised palliative care (SPC) at home in Denmark. METHODS: A stepped-wedge cluster randomised controlled trial with nine clusters (ie, SPC teams). Outcome measures were collected using caregiver questionnaires at baseline (T0) and 2-week (T1) and 4-week (T2) follow-up. RESULTS: A total of 437 caregivers were enrolled (control group, n=255; intervention group, n=182). No intervention effect was found on the primary outcome, caregiver strain at T1 (p=0.1865). However, positive effects were found at T1 and T2 on attention to caregivers' well-being (p<0.0001), quality of information and communication (p<0.0001), amount of information (T1: p=0.0002; T2: p<0.0001), involvement (T1: p=0.0045; T2: p<0.0001), talking about greatest burdens (p<0.0001) and assistance in managing greatest burdens (p<0.0001). The effect sizes of these differences were medium or large and seemed to increase from T1 to T2. At T1, positive effects were found on distress (p=0.0178) and home care responsibility (p=0.0024). No effect was found on the remaining outcomes. CONCLUSION: Although no effect was found on caregiver strain, the CSNAT-I showed positive effects on caregiver distress, home care responsibility and key outcomes regarding caregivers' experience of the interaction with healthcare professionals. TRIAL REGISTRATION NUMBER: NCT03466580.

Assessing Emotional Functioning with Increased Power: Relative Validity of a Customized EORTC Short Form in the International ACTION Trial.

OBJECTIVES: There is a need to improve the assessment of emotional functioning (EF). In the international Advance Care Planning: an Innovative Palliative Care Intervention to Improve Quality of Life in Cancer Patients - a Multi-Centre Cluster Randomized Clinical Trial (ACTION) trial involving patients with advanced cancer, EF was assessed by a customized 10-item short form (EF10). The EF10 is based on the European Organisation for Research and Treatment of Cancer (EORTC) EF item bank and has the potential for greater precision than the common EORTC Quality of Life Questionnaire Core 30 four-item scale (EF4). We assessed the relative validity (RV) of EF10 compared with EF4. METHODS: Patients from Belgium, Denmark, Italy, the Netherlands, Slovenia, and the United Kingdom completed EF10 and EF4, and provided data on generic quality of life, coping, self-efficacy, and personal characteristics. Based on clinical and sociodemographic variables and questionnaire responses, 53 "known groups" that were expected to differ were formed, for example, females versus males. The EF10 and EF4 were first independently compared within this known group, for example, the EF10 score of females vs the EF10 score of males. When these differences were significant, the RV was calculated for the comparison of the EF10 with the EF4. RESULTS: A total of 1028 patients (57% lung, 43% colorectal cancer) participated. Forty-five of the 53 known-groups comparisons were significantly different and were used for calculating the RV. In 41 of 45 (91%) comparisons, the RV was more than 1, meaning that EF10 had a higher RV than EF4. The mean RV of EF10 compared with that of EF4 was 1.41, indicating superior statistical power of EF10 to detect differences in EF. CONCLUSIONS: Compared with EF4, EF10 shows superior power, allowing a 20% to 34% smaller sample size without reducing power, when used as a primary outcome measure.

The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire.

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.

Health-related quality of life in melanoma patients: Impact of melanoma-related limb lymphoedema.

AIM: To explore health-related quality of life (HRQoL) in recurrence-free melanoma patients, with a focus on the association between melanoma-related limb lymphoedema and HRQoL. METHODS: HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the breast cancer module (EORTC QLQ-BR23) subscales body image and future perspective, the Functional Assessment for Cancer Therapy-General subscale social/family well-being and the Hospital Anxiety and Depression Scale. Data were analysed using linear and ordinal logistic regression adjusting for age and gender. RESULTS: A total of 431 melanoma patients who had undergone wide local excision and axillary or inguinal sentinel lymph node biopsy (SLNB) and/or complete lymph node dissection (CLND) participated. No patients had had recurrence of the disease or had received adjuvant radiotherapy. The HRQoL scores improved with time after surgery. Melanoma-related limb lymphoedema was present in 109 patients (25%). Patients with lymphoedema had significantly worse HRQoL scores in the EORTC QLQ-C30 subscales global health status/quality of life, role and social functioning, fatigue, pain and financial difficulties, as well as in the QLQ-BR23 body image subscale. No associations were found between the limb affected (upper or lower limb), clinical stage of lymphoedema, duration of lymphoedema or type of surgery (SLNB or CLND) and HRQoL. We found an interaction with age and gender in the associations between lymphoedema and HRQoL: younger patients and women with lymphoedema had worse social functioning and women had significantly more impaired body image. CONCLUSIONS: The negative impact of melanoma-related limb lymphoedema on HRQoL emphasises the importance of developing strategies for increasing awareness and improving prevention and treatment of lymphoedema.

Is admittance to specialised palliative care among cancer patients related to sex, age and cancer diagnosis? A nation-wide study from the Danish Palliative Care Database (DPD).

BACKGROUND: Specialised palliative care (SPC) takes place in specialised services for patients with complex symptoms and problems. Little is known about what determines the admission of patients to SPC and whether there are differences in relation to institution type. The aims of the study were to investigate whether cancer patients' admittance to SPC in Denmark varied in relation to sex, age and diagnosis, and whether the patterns differed by type of institution (hospital-based palliative care team/unit, hospice, or both). METHODS: This was a register-based study of adult patients living in Denmark who died from cancer in 2010-2012. Data sources were the Danish Palliative Care Database, Danish Register of Causes of Death and Danish Cancer Registry. The associations between the explanatory variables (sex, age, diagnosis) and admittance to SPC were investigated using logistic regression. RESULTS: In the study population (N = 44,548) the overall admittance proportion to SPC was 37%. Higher odds of overall admittance to SPC were found for women (OR = 1.23; 1.17-1.28), younger patients (<40 compared with 80+ years old) (OR = 6.44; 5.19-7.99) and patients with sarcoma, pancreatic and stomach cancers, whereas the lowest were for patients with haematological malignancies. The higher admission found for women was most pronounced for hospices compared to hospital-based palliative care teams/units, whereas higher admission of younger patients was more pronounced for hospital-based palliative care teams/units. Patients with brain cancer were more often admitted to hospices, whereas patients with prostate cancer were more often admitted to hospital-based palliative care teams/units. CONCLUSION: It is unlikely that the variations in relation to sex, age and cancer diagnoses can be fully explained by differences in need. Future research should investigate whether the groups having the lowest admittance to SPC receive sufficient palliative care elsewhere.

Comparing three different approaches to the measurement of needs concerning fatigue in patients with advanced cancer.

PURPOSE: To identify patients having fatigue, it is necessary to assess the patients fatigue systematically. This study investigates three different approaches to the assessment of needs concerning fatigue in patients with advanced cancer and addresses the following questions. METHODS: In a cross-sectional nationwide survey, patients were asked about their needs concerning fatigue in three different ways: Fatigue intensity was measured with the European Organisation for Research and Treatment of Cancer quality of life questionnaire, fatigue burden (the extent fatigue was a problem) and fatigue felt need (whether the patient experienced an unmet need regarding their fatigue) was measured with the Three-Levels-of-Needs Questionnaire. The relations between these three approaches were investigated using cross-tabulations, polychromic correlations, receiver operating curves, and area under the curve. RESULTS: In total, 1447 patients participated (61 %). Of these, 34 % reported at least quite a bit fatigue (intensity), 36 % reported at least quite a bit fatigue burden, and 35 % reported experiencing an unmet need. There was a high correlation between fatigue intensity and fatigue burden (0.91). Fatigue intensity was also correlated with experiencing an unmet need and having at least a little fatigue predicted experiencing an unmet need. CONCLUSION: Overall, no matter which approach was used, about a third of the patients had a need concerning fatigue. In nearly all cases, patients who had fatigue also experienced fatigue to be a problem. The QLQ-C30 item 'Were you tired' worked as a screening tool to identify patients experiencing an unmet need concerning fatigue.

The interaction between informal cancer caregivers and health care professionals: a survey of caregivers' experiences of problems and unmet needs.

PURPOSE: In order to meet the caregiving challenges, informal caregivers often need a substantial level of interaction with health care professionals (HCPs). This study investigated to which extent the cancer caregivers' needs regarding the interaction with HCPs are met and the associations between dissatisfaction with the interaction and socio-demographic and disease-related variables. METHODS: In a cross-sectional questionnaire study, cancer patients with various diagnoses and disease stages were invited to pass on the 'cancer caregiving tasks, consequences and needs questionnaire' (CaTCoN) to up to three of their caregivers. RESULTS: A total of 590 caregivers (related to 415 (55 %) of 752 eligible patients) participated. Although many caregivers were satisfied, considerable proportions experienced problems or had unmet needs regarding the interaction with HCPs. Prominent problematic aspects included optimal involvement of the caregivers in the patients' disease, treatment and/or care (30 % were dissatisfied), attention to the caregivers' wellbeing (e.g., 51 % of the caregivers reported that HCPs only sometimes or rarely/never had shown interest in how the caregivers had been feeling), and provision of enough information to the caregivers (e.g. 39 % were dissatisfied with the amount of time spent on informing caregivers). The patients' adult children and siblings, younger caregivers and caregivers to younger patients tended to report the highest levels of interaction problems and unmet needs. CONCLUSIONS: The caregivers' dissatisfaction with the interaction with HCPs was pronounced. More focus on and involvement of the caregivers, in a way that matches the caregivers' needs, is still warranted.

Confirmatory factor analysis of the thyroid-related quality of life questionnaire ThyPRO.

BACKGROUND AND AIM: Thyroid diseases are prevalent and chronic. With treatment, quality of life is restored in most, but not all patients. Construct validity of the thyroid-related quality of life questionnaire, ThyPRO, has been established by multi-trait scaling, but not evaluated with more elaborate methods. The purpose of the present study was to evaluate dimensionality of the ThyPRO scales and to attempt to understand possible item misfit through structural equation modeling for categorical data. METHODS: The current 85-item version of ThyPRO consists of 13 scales, covering domains of physical (4 scales) and mental (2 scales) symptoms, function and well-being (3 scales) and participation/social function (4 scales). The data were collected from a cross-sectional sample of 907 thyroid patients. One-factor confirmatory models were fitted to each scale, and evaluated by model fit statistics (comparative fit index >0.95, root mean square error of approximation <0.08), magnitude of factor loadings, model residual correlations and modification indices (MI). Indications of multi-dimensionality were tested in bi-factor models. Possible item misfit was evaluated in a combined, investigational model. RESULTS: Each ThyPRO scale was adequately represented by a unidimensional model after minor revisions. Eleven items were identified in the unidimensional models as potentially misfitting and were investigated further by multidimensional modeling. CONCLUSION: Elaborate psychometric modeling supported the construct validity of the ThyPRO. However, 11 potentially misfitting items and 18 items with local dependence to other items are candidates for removal in future item reduction processes.

Cancer caregiving tasks and consequences and their associations with caregiver status and the caregiver's relationship to the patient: a survey.

BACKGROUND: Seriously ill patients often depend on their informal caregivers to help and support them through the disease course. This study investigated informal cancer caregivers' experiences of caregiving tasks and consequences and how caregiver status (primary vs. non-primary caregiver) and the caregiver's relationship to the patient (spouse/partner, etc.) are related to these experiences. METHODS: In a cross-sectional questionnaire study, randomly selected cancer patients with a range of diagnoses and disease stages were invited to pass on the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN) to 1-3 of their caregivers. RESULTS: A total of 590 caregivers related to 415 (55% of 752 eligible) cancer patients participated. Large proportions of caregivers experienced substantial caregiving workload, e.g., provision of psychological support (74%), as well as a range of negative consequences, most commonly stress (59%). Some caregivers experienced personal growth, but relatively large proportions did not. Caregiver status and the caregiver's relationship to the patient were associated with some caregiving aspects. Primary caregivers experienced the highest caregiving workload, and non-primary caregivers experienced most problems with getting time off from work. Spouses/partners and/or parents experienced the highest workload, most lack of time for social relations, most financial difficulties, and had the greatest need for seeing a psychologist. They furthermore experienced the highest degree of personal growth and had the smallest need for living a normal life while being a caregiver. Yet, regarding the majority of caregiving aspects, no associations with caregiver status or the caregiver's relationship to the patient were found. CONCLUSIONS: Overall, the findings confirm that cancer caregiving is burdensome. The primary and the closest caregivers seemed to take on most caregiving tasks, but, contrary to expectations, regarding the majority of caregiving consequences non-primary and more distant caregivers were affected to the same degree as the primary and closest caregivers. Initiatives and interventions to support not only the primary caregivers are therefore warranted.

Do advanced cancer patients in Denmark receive the help they need? A nationally representative survey of the need related to 12 frequent symptoms/problems.

OBJECTIVES: The aim of the study was to investigate the adequacy of help delivered by the healthcare system for 12 symptoms/problems in a national, randomly selected sample of advanced cancer patients in Denmark. METHODS: Advanced cancer patients (n = 1630) from 54 hospital departments across Denmark received the 3-Levels-of-Needs Questionnaire (3LNQ). The 3LNQ measures 'problem burden', the degree to which a symptom or problem is perceived as a problem, and 'felt need', whether the patient receives adequate help. Prevalences were calculated for 'problems' (at least 'a little' of a problem), 'moderate/severe problems' (at least 'quite a bit' of a problem) and 'felt need' (inadequate help or no help despite wanting it). RESULTS: In total, 977 (60%) patients participated. The most frequent 'problems' were fatigue (73%; 'moderate/severe' 36%) and limitations doing physical activities (65%; 'moderate/severe' 36%). For the 12 symptoms/problems assessed the prevalence of 'felt need' was 11-35%. Of the patients who had received help, 34-74% viewed the help as inadequate. Of those who had not received help, 48-78% wished for help. CONCLUSION: Advanced cancer patients are not receiving the help they need. Large proportions of patients were burdened by symptoms/problems. Of those who had received help, many viewed it as inadequate. Better symptom/problem identification and management is warranted for advanced cancer patients.

The initial development of the 'Cancer Caregiving Tasks, Consequences and Needs Questionnaire' (CaTCoN).

AIMS: To develop a questionnaire for cancer patients' informal caregivers, measuring the caregiving tasks and consequences, and the caregivers' needs with a main focus on the interaction with the health care professionals. Such an instrument is needed to evaluate the efforts directed towards caregivers in the health care system. MATERIAL AND METHODS: In order to identify themes relevant for the questionnaire, existing literature was reviewed and supplemented with focus group interviews with cancer patients' caregivers, cancer patients, clinicians, and cancer counselors. For each of the identified themes, one or more items were developed. During the development process, the items were evaluated by cognitive interviews in order to reduce problems with comprehension and response. RESULTS: The literature review and eight focus group interviews with a total of 39 participants resulted in a list of relevant themes concerning the caregiving tasks and consequences, and the caregivers' needs. Subsequently, items were developed, covering each relevant theme, and the questionnaire draft was evaluated by cognitive interviews with 24 caregivers. All in all, eight versions of the full questionnaire were evaluated, and furthermore, two items in the final version were evaluated in eight additional interviews. The final version of the questionnaire, called the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN), contains 41 items. CONCLUSION: The CaTCoN aims to measure the extent of cancer caregiving tasks and consequences, and the caregivers' needs, mainly concerning information from and communication and contact with the health care professionals. The psychometric properties of the instrument need to be evaluated before the CaTCoN is ready for use.

Using mixed methods to assess how cancer patients' needs in relation to their relatives are met in the Danish health care system: a report from the population-based study "The Cancer Patient's World".

AIM: The aims of this paper were to validate four items assessing how patients' needs regarding support to and from their relatives are met and to investigate patients' evaluation of this support. METHOD: Items were validated by patient-observer agreement and cognitive interviews. Adequacy of support was assessed in a cross-sectional study of 1,490 Danish cancer patients; 147 of these also answered an open-ended question. RESULTS: All items performed well in the validation. Only 4 % reported lack of support from their relatives, whereas 9 and 11 % had lacked support from the health care professionals regarding how to tell the relatives about the disease and regarding the relatives in general, respectively. Although the patients' expectations are not unequivocal, a large proportion (35 %) reported that the health care professionals had shown little interest in how the relatives were doing. This was most pronounced for female patients and patients sampled in urban areas. Compared to older patients, younger patients lacked more support with respect to the relatives in general and regarding how to tell them about the disease. Divorced patients were less satisfied than married patients on all measures. CONCLUSION: While most patients felt well-supported by their relatives, the oldest, the divorced, and those without children may be a vulnerable group. Many patients reported that the health care staff showed insufficient interest in the well-being of the relatives. Thus, it may be beneficial for both the patient and the relatives if health care professionals acknowledge and support the relatives in fulfilling their important role as caregiver and companion.

Are different groups of cancer patients offered rehabilitation to the same extent? A report from the population-based study "The Cancer Patient's World".

PURPOSE: The number of cancer survivors is growing and cancer is now viewed as a chronic disease. This has highlighted the importance of providing adequate rehabilitation to prevent physical, psychological, and social sequelae of cancer. However, it is unclear whether those in need of rehabilitation are offered this. METHODS: Using patient-observer agreement and cognitive interviews, we validated a seven-item questionnaire designed to assess cancer patients' perception of the sufficiency of the offered rehabilitation. A cross-sectional study among 2,202 Danish cancer patients affiliated with hospitals was carried out. RESULTS: The questionnaire was well understood, indicating good validity. In the cross-sectional study, 1,490 patients (68%) participated. Up to 39% of cancer patients did not receive the physical rehabilitation they felt they needed. About half of those who had felt a need to talk to a psychologist were offered this. Insufficiency of other rehabilitation offers was reported by 10-24%. Age most consistently predicted insufficient rehabilitation; higher age predicted insufficient information about support from other sources (than hospital staff) and younger age predicted lack of help to manage symptoms, return to everyday life, and deal with financial and especially work-related consequences. We found no consistent signs of traditional social inequality in the perception of rehabilitation, but we observed some signs of social inequality for unemployed or divorced/separated patients. CONCLUSIONS: Age predicted sufficiency of the rehabilitation in two directions, possibly reflecting different needs in younger and older patients. When tailoring rehabilitation programs, it should be ensured that the different needs are met.

Development and initial validation of the Three-Levels-of-Needs Questionnaire for self-assessment of palliative needs in patients with cancer.

CONTEXT: To improve palliative care, it is important that questionnaires accurately assess the needs of the patients. No questionnaire existed that combined three different and important approaches to needs assessment. We developed such a questionnaire, called the Three-Levels-of-Needs Questionnaire (3LNQ), based on literature searches. The 3LNQ measures 12 important needs with three different approaches when used as a supplement to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): problem intensity, problem burden, and felt need. OBJECTIVES: To investigate the initial validity of the 3LNQ. METHODS: We used a relatively new method that investigates whether the questionnaire has the same meaning for the patients as for the researchers. To do this, 74 patients with advanced cancer filled out the questionnaire and participated in an open-ended interview. The patients' responses to the questionnaire before the interview were compared against the researchers' responses based on the interviews. Items showing substantial agreement were accepted as valid without further analysis. For the remaining items, reasons for disagreements were analyzed qualitatively. RESULTS: All items on problem intensity, eight of 12 items on problem burden, and three of 12 items on felt need were accepted as valid because of high agreement. Analysis of the qualitative data concerning the remaining items showed that most disagreements did not indicate problems with the patients' self-assessment. Instead, different causes for disagreements were elucidated, but these did not interfere with validity. CONCLUSION: The 3LNQ appears to measure palliative needs comprehensively, and this initial validation showed satisfactory results. The analysis gave important insights into the patients' perceptions of their own situations, into their expectations of the health care system, and into the complexity of needs assessment.

Expert conference on cancer pain assessment and classification--the need for international consensus: working proposals on international standards.

An increasing number of cancer patients live longer, and palliative care has become an important part of their treatment. Symptoms are often inadequately assessed and managed. A significant challenge in clinical trials is to control for the variability of the samples being studied. To overcome this problem, classification systems have been developed in order to characterise and stratify patients by grouping them according to major common characteristics. The lack of agreed methods for the assessment and classification of cancer pain has been clearly indicated in clinical trials and in clinical practice and may be one possible explanation for the inadequate treatment of cancer pain. This was the background to an international expert meeting arranged in September 2009 in Milan, Italy. The primary aims were to produce recommendations on how to assess and classify cancer pain and to recommend a strategy for the further development, validation and implementation of an international cancer pain classification and assessment system. The recommendations consisted of two basic working proposals, nine specific working proposals and seven recommendations for the further development of a cancer pain classification system. Examples of specific working proposals were to include pain intensity, pain mechanism, breakthrough pain and psychological distress as the core domains in this classification of cancer pain and to measure pain intensity with a 0-10 numerical rating scale with 'no pain' and 'pain as bad as you can imagine' as anchors. The proposed name for this international standard is Cancer Pain Assessment and Classification System (CPACS).