The first decade of the Danish Palliative Care Database: improvements and ongoing challenges in the quality and use of specialised palliative care.

BACKGROUND: Danish Palliative Care Database comprises five quality indicators: (1) Contact with specialised palliative care (SPC) among referred patients, (2) Waiting time of less than 10 days, (3) Proportion of patients who died from (A) cancer or (B) non-cancer diseases, and had contact with SPC, (4) Proportion of patients completing the patient-reported outcome measure at baseline (EORTC QLQ-C15-PAL), and (5) Proportion of patients discussed at a multidisciplinary conference. PURPOSE: To investigate changes in the quality indicators from 2010 until 2020 in cancer and non-cancer patients. Patients/material: Patients aged 18+ years who died from 2010 until 2020. METHOD: Register-based study with the Danish Palliative Care Database as the main data source. Indicator changes were reported as percentage fulfilment. RESULTS: From 2010 until 2020, the proportion of patients with non-cancer diseases in SPC increased slightly (2.5-7.2%). In 2019, fulfilment of the five indicators for cancer and non-cancer were: (1) 81% vs. 73%; (2) 73% vs. 68%; (3A) 50%; (3B) 2%; (4) 73% vs. 66%; (5) 73% vs. 65%. Whereas all other indicators improved, the proportion of patients waiting less than 10 days from referral to contact decreased. Differences between type of unit were found, mainly lower for hospice. INTERPRETATION: Most patients in SPC had cancer. All indicators except waiting time improved during the 10-year period. The establishment of the Danish Palliative Care Database may have contributed to the positive development; however, SPC in Denmark needs to be improved, especially regarding a reduction in waiting time and enhanced contact for non-cancer patients.

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.

Symptoms and problems reported by patients with non-cancer diseases through open-ended questions in specialist palliative care: a national register-based study.

PURPOSE: Since 2010, a comprehensive symptom/problem (S/P) assessment has been carried out in Danish specialist palliative care using the EORTC QLQ-C15-PAL questionnaire and the open-ended "Write In three Symptoms/Problems" (WISP) instrument. On WISP patients can report up to three S/Ps not included in the EORTC QLQ-C15-PAL. However, little is known about which S/Ps patients with non-cancer diseases report using WISP. Therefore, we investigated the prevalence and severity of S/Ps reported on WISP by non-cancer patients in specialist palliative care and compared these S/Ps with those previously reported by cancer patients. METHODS: This register-based study collected data from the Danish Palliative Care Database. We included adult patients with non-cancer diseases answering the EORTC QLQ-C15-PAL at admittance to specialist palliative care between 2016 and 2021. WISP responses were qualitatively categorized, and their prevalence and severity calculated. RESULTS: Of the 2323 patients with non-cancer diseases answering the EORTC QLQ-C15-PAL, 812 (34.9%) reported at least one S/P using WISP. A total of 1340 S/Ps were reported on WISP, of which 56.7% were not included in the EORTC QLQ-C15-PAL (i.e., were new). Edema, existential problems, dizziness, cough, and dysphagia were the most prevalent new S/Ps. Overall, 88.7% of the S/Ps were scored as moderate-severe. The prevalence of S/Ps reported on WISP did not significantly differ between cancer and non-cancer patients, except for existential problems, dysphagia, myoclonus, speaking problems, sweats, and vomiting. CONCLUSION: The similarities and differences in the prevalence of the most common S/Ps reported on WISP confirm that WISP improves symptom assessment regardless of patient diagnosis.

Development of standard computerised adaptive test (CAT) settings for the EORTC CAT Core.

AIMS: Computerised adaptive test (CAT) provides individualised patient reported outcome measurement while retaining direct comparability of scores across patients and studies. Optimal CAT measurement requires an appropriate CAT-setting, the set of criteria defining the CAT including start item, item selection criterion, and stop criterion. The European Organisation for Research and Treatment of Cancer (EORTC) CAT Core allows for assessing the 14 functional and symptom domains covered by the EORTC QLQ-C30 questionnaire. The aim was to present a general approach for selecting CAT-settings and to use this to develop a portfolio of standard settings for the EORTC CAT Core optimised for different purposes and populations. METHODS: Using simulations, the measurement properties of CATs of different length and precision were evaluated and compared allowing for identifying the most suitable settings. All CATs were initiated with the most informative QLQ-C30 item. For each domain two fixed-length and two fixed-precision standard CATs were selected focusing on efficiency (brief version) and precision (long), respectively. RESULTS: The brief fixed-length CATs included 3-5 items each while the long versions included 5-8 items. The fixed-precision CATs aimed for reliability of 0.65-0.95 (brief versions) and 0.85-0.98 (long versions), respectively. Median sample size savings using the CATs compared to the QLQ-C30 scales ranged 20%-31%, although savings varied considerably across the domains. CONCLUSION: The EORTC CAT Core standard settings simplify selection of relevant and appropriate CATs. The CATs prioritise either brevity and efficiency or precision, but all provide increased measurement precision and hence, reduced sample size requirements compared to the QLQ-C30 scales. The CATs may be used as they are or modified to accommodate specific requirements.

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.

Content comparison of the EORTC CAT Core, SF-36, FACT-G, and PROMIS role and social functioning measures based on the International Classification of Functioning, Disability and Health.

OBJECTIVES: In line with the World Health Organizations' health definition, patient-reported outcome (PRO) measures frequently cover aspects of social health. Our study aimed to evaluate the role functioning (RF) and social functioning (SF) contents assessed by PRO measures commonly used in cancer patients. METHODS: We analysed the item content of the SF and RF domains of the EORTC CAT Core, the EORTC QLQ-C30, the SF-36, and the FACT-G as well as the PROMIS item bank covering the Ability to Participate in Social Roles and Activities. Following an established methodology we linked item content to the International Classification of Functioning, Disability and Health (ICF) framework. RESULTS: The content of 85 items was assigned to three ICF components ('Activities and Participation', 'Body Functions', and 'Environmental Factors'). The EORTC CAT Core RF items were mostly related to the first-level ICF categories 'Domestic life' and 'Community, social and civic life', while its SF item bank focused on 'Interpersonal interactions and relationships'. These three categories were also covered by the PROMIS social participation item bank. The FACT-G Social/Family scale focused on environmental factors ('Support and Relationships' and 'Attitudes') while the SF-36 Role-physical/emotional scales had a stronger focus on 'General tasks and demands' and 'Major life areas'. CONCLUSIONS: Our results highlight conceptual overlap and differences among PRO measures for the assessment of social health in cancer. This information may help to select the most appropriate measure for a specific setting or study purpose and to better understand the possibilities of linking scores across different PRO measures.

Higher overall admittance of immigrants to specialised palliative care in Denmark: a nationwide register-based study of 99,624 patients with cancer.

BACKGROUND: The population of immigrants in Europe is ageing. Accordingly, the number of immigrants with life-threatening diseases and need for specialised palliative care will increase. In Europe, immigrants' admittance to specialised palliative care is not well explored. AIM: To investigate whether country of origin was associated with admittance to (I) palliative care team/unit, (II) hospice, and/or (III) specialised palliative care, overall (i.e. palliative care team/unit and/or hospice). DESIGN: Data sources for the population cohort study were the Danish Palliative Care Database and several nationwide registers. We investigated the associations between country of origin and admittance to specialised palliative care, overall, and to type of palliative care using logistic regression analyses. SETTING/PARTICIPANTS: In 2010-2016, 104,775 cancer patients died in Denmark: 96% were born in Denmark, 2% in other Western countries, and 2% in non-Western countries. RESULTS: Overall admittance to specialised palliative care was higher for immigrants from other Western (OR = 1.13; 95%CI: 1.03-1.24) and non-Western countries (OR = 1.22; 95%CI: 1.08-1.37) than for the majority population. Similar results were found for admittance to palliative care teams. No difference in admittance to hospice was found for immigrants from other Western countries (OR = 1.04; 95%CI: 0.93-1.16) compared to the majority population, while lower admittance was found for non-Western immigrants (OR = 0.70; 95%CI: 0.60-0.81). CONCLUSION: Admittance to specialised palliative care was higher for immigrants than for the majority population as higher admittance to palliative care teams for non-Western immigrants more than compensated for the lower hospice admittance. This may reflect a combination of larger needs and that hospital-based and home-based services are perceived as preferable by immigrants.

Development of a diverse set of standard short forms based on the EORTC CAT Core item banks.

PURPOSE: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed item banks covering the 14 domains of the EORTC QLQ-C30 quality of life questionnaire. These allow for dynamic assessment and for forming population/study specific static short forms. To simplify selection of relevant short forms, we here present a portfolio of standard short forms with measurement properties optimized for different populations. METHODS: For each domain, a brief and a long version were constructed for each of three populations having mild, moderate, and severe symptoms, respectively. The most informative items were prioritised while also taking content into consideration. All short forms included at least one QLQ-C30 item. The measurement precision/power of the short forms was compared to the corresponding QLQ-C30 scales using simulations. RESULTS: In total, 84 short forms were constructed. The brief versions included 3-5 items each, the long versions 5-9 items. Estimated sample size savings using the suggested short forms while maintaining the same power as with the QLQ-C30 ranged 3-50% across domains with median savings of 19% (brief versions) and 28% (long versions), respectively. CONCLUSION: The suggested short forms allow for simple selection of items particularly relevant for patients with mild, moderate, or severe symptoms, respectively. They facilitate the use of smaller samples without loss of power compared to the QLQ-C30 scales. The suggested short forms may be used as they are or adapted to the specific aims of individual studies/settings.

Implementation of clinical guidelines in specialized palliative care-results from a national improvement project: A national register-based study.

BACKGROUND: Knowledge about the process and the results of the implementation of clinical guidelines to improve palliative care is limited. A national project aimed at improving the quality of life of advanced cancer patients admitted to specialized palliative care services in Denmark by implementing clinical guidelines for the treatment of pain, dyspnea, constipation, and depression. AIM: To investigate the degree of clinical guideline implementation by evaluating the proportion of patients treated according to guidelines among those who qualified (i.e. reported severe symptom level) before and after the 44 palliative care services implemented the guidelines, and how often different types of interventions were provided. DESIGN: This is a national register-based study. SETTING/PARTICIPANTS: Data from the improvement project were stored in and later obtained from the Danish Palliative Care Database. Adult patients with advanced cancer admitted to palliative care between September 2017 and June 2019 who answered the EORTC QLQ-C15-PAL questionnaire were included. RESULTS: In total 11,330 patients answered the EORTC QLQ-C15-PAL. The proportions of services that implemented the four guidelines ranged 73%-93%. Among services that had implemented guidelines, the proportion of patients receiving interventions was roughly constant over time reaching between 54% and 86% (lowest for depression). Pain and constipation were frequently treated pharmacologically (66%-72%), whereas dyspnea and depression were frequently treated non-pharmacologically (61% each). CONCLUSIONS: Implementing clinical guidelines was more successful for physical symptoms than for depression. The project generated national data on interventions provided when guidelines were followed, which may be used to understand differences in care and outcomes.

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.

The quality of end of life care for Danish cancer patients who have received specialized palliative: a national survey using the Danish version of VOICES-SF.

BACKGROUND: National recommendations state that Danish patients with complex palliative needs should have access to specialized palliative care but little is known about the perceived quality of this care or end of life care in general. AIM: To assess how end of life care was evaluated by the bereaved spouses and to investigate whether the perceived quality was associated with (1) quantity of specialized palliative care provided, (2) place of death, and (3) emotional state when completing the questionnaire. DESIGN: The bereaved spouses of 1584 cancer patients who had received specialized palliative care were invited to answer the Views Of Informal Carers - Evaluation of Services - Short Form (VOICES-SF) and the Hospital Anxiety and Depression Scale (HADS) approximately 3-9 months after the patient's death. RESULTS: A total of 787 (50%) of the invited spouses participated. In the last 3 months of the patient's life, the quality of all services taken together was rated as good, excellent, or outstanding in 83% of the cases and it was significantly associated with place of death (p = 0.0051, fewest considered it "fair" or "poor" if the patient died at home). In total, 93% reported that the patient died at the right place although only 74% died at the patient's preferred place. Higher levels of anxiety (p = 0.01) but not depression at the time of questionnaire completion was associated with lower satisfaction with the overall quality of care. CONCLUSION: The quality of care was rated very highly by bereaved spouses of patients receiving specialized palliative care.

The quality of end-of-life care for Danish cancer patients who have received non-specialized palliative care: a national survey using the Danish version of VOICES-SF.

PURPOSE: About half of Danish patients dying from cancer have never been in contact with specialized palliative care. Non-specialized palliative care in Denmark, i.e., somatic hospital departments, community nurses, and general practitioners, has rarely been described or evaluated. We aim to assess how non-specialized palliative care was evaluated by bereaved spouses, and to test whether distress when completing the questionnaire and ratings of aspects of end-of-life care was associated with satisfaction with place of death and overall quality of end-of-life care. METHODS: Bereaved spouses of 792 cancer patients who had received non-specialized palliative care were invited to answer the Views of Informal Carers-Evaluation of Services-Short Form (VOICES-SF) and the Hospital Anxiety and Depression Scale (HADS) 3-9 months after the patient's death. RESULTS: A total of 280 (36%) of invited spouses participated. In the last 3 months of the patient's life, the quality of all services taken together was rated as good, excellent, or outstanding in 70% of the cases. Satisfaction was associated with respondent's current distress (p = 0.0004). Eighty percent of bereaved spouses believed that the patient had died in the right place. Satisfaction with place of death was associated with place of death (p = 0.012) and the respondent's current distress (p = 0.0016). CONCLUSION: Satisfaction with place of death and overall quality of services was generally high but was rated lower by spouses reporting higher levels of distress when completing the questionnaire. Distress should be taken into account whenever services are evaluated by bereaved relatives.

Nausea at the start of specialized palliative care and change in nausea after the first weeks of palliative care were associated with cancer site, gender, and type of palliative care service-a nationwide study.

PURPOSE: Nausea is a common and distressful symptom among patients in palliative care, but little is known about possible socio-demographic and clinical patient characteristics associated with nausea at the start of palliative care and change after initiation of palliative care. The aim of this study was to investigate whether patient characteristics were associated with nausea at the start of palliative care and with change in nausea during the first weeks of palliative care, respectively. METHODS: Data was obtained from the nationwide Danish Palliative Care Database. The study included adult cancer patients who were admitted to palliative care and died between June 2016 and December 2020 and reported nausea level at the start of palliative care and possibly 1-4 weeks later. The associations between patient characteristics and nausea at the start of palliative care and change in nausea during palliative care, respectively, were studied using multiple regression analyses. RESULTS: Nausea level was reported at the start of palliative care by 23,751 patients of whom 8037 also reported 1-4 weeks later. Higher nausea levels were found for women, patients with stomach or ovarian cancer, and inpatients at the start of palliative care. In multivariate analyses, cancer site was the variable most strongly associated with nausea change; the smallest nausea reductions were seen for myelomatosis and no reduction was seen for stomach cancer. CONCLUSION: This study identified subgroups with the highest initial nausea level and those with the least nausea reduction after 1-4 weeks of palliative care. These latter findings should be considered in the initial treatment plan.

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.

Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials.

BACKGROUND: The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer. METHODS: We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians' input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated. RESULTS: Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and - 13 to - 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and - 10 to - 5 for deterioration. CONCLUSIONS: Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

Investigating the response scale of the EORTC QLQ-C30 in German cancer patients and a population survey.

BACKGROUND: The European Organization for research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) scales are scored on a 4-point response scale, ranging from not at all to very much. Previous studies have shown that the German translation of the response option quite a bit as mäßig violates interval scale assumptions, and that ziemlich is a more appropriate translation. The present studies investigated differences between the two questionnaire versions. METHODS: The first study employed a balanced cross-over design and included 450 patients with different types of cancer from three German-speaking countries. The second study was a representative survey in Germany including 2033 respondents. The main analyses included compared the ziemlich and mäßig version of the questionnaire using analyses of covariance adjusted for sex, age, and health burden. RESULTS: In accordance with our hypothesis, the adjusted summary score was lower in the mäßig than in the ziemlich version; Study 1: - 4.5 (95% CI - 7.8 to - 1.3), p = 0.006, Study 2: - 3.1 (95% CI - 4.6 to - 1.5), p < 0.001. In both studies, this effect was pronounced in respondents with a higher health burden; Study 1: - 6.8 (95% CI - 12.2 to - 1.4), p = 0.013; Study 2: - 4.5 (95% CI - 7.3 to - 1.7), p = 0.002. CONCLUSIONS: We found subtle but consistent differences between the two questionnaire versions. We recommend to use the optimized response option for the EORTC QLQ-C30 as well as for all other German modules. TRIAL REGISTRATION: The study was retrospectively registered on the German Registry for Clinical Studies (reference number DRKS00012759, 04th August 2017, https://www.drks.de/DRKS00012759 ).

Functional impairment, symptom severity, and overall quality of life in patients with advanced lung or colorectal cancer in six European countries: baseline findings from the ACTION study.

BACKGROUND: People with advanced cancer often suffer from various symptoms, which can arise from the cancer itself and its treatment, the illness experience, and/or co-morbid conditions. Important patient-reported outcomes such as functional status, symptom severity, and quality of life (QoL) might differ between countries, as countries vary with regard to contextual factors such as their healthcare system. PURPOSE: To assess self-reported emotional functioning, physical functioning, symptoms, and overall QoL in patients with advanced lung or colorectal cancer from six European countries, particularly in relation to their country of residence. METHODS: We used baseline patient data from the ACTION trial, including socio-demographic and clinical data as well as patient-reported data regarding functioning, symptoms, and overall QoL (EORTC QLQ-C15-PAL). RESULTS: Data from 1117 patients (55% lung cancer stage III/IV, 45% colorectal cancer stage IV) were used. The highest (worst) average symptom score was found for fatigue. We found similarities but also important differences in the outcomes across countries. The best scores (the highest for emotional functioning and QoL, the lowest for symptoms) were reported by Dutch and Danish patients. Belgian patients reported relatively low emotional functioning. CONCLUSION: The optimization of functioning, symptom relief, and overall QoL should be important objectives of healthcare professionals who take care of patients with advanced cancer. There are similarities, but also substantial differences across countries in functional status, symptoms, and overall QoL. Policymakers should take these differences into account and invest in offering health care catered to the needs of their population.

Early, integrated palliative rehabilitation improves quality of life of patients with newly diagnosed advanced cancer: The Pal-Rehab randomized controlled trial.

BACKGROUND: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. AIM: We hypothesized that early integration of palliative rehabilitation could improve quality of life. DESIGN: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. SETTING/PARTICIPANTS: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a "primary problem" from a list of QLQ-C30 domains. The primary endpoint was the change in that "primary problem" measured as area under the curve across 12 weeks (T-scores, European mean value = 50, SD = 10). RESULTS: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0-6.0]; p = 0.047) favoring the intervention. CONCLUSION: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancer patients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014.

Regional and age differences in specialised palliative care for patients with pancreatic cancer.

BACKGROUND: Despite national recommendations, disparities in specialised palliative care (SPC) admittance have been reported. The aims of this study were to characterize SPC admittance in patients with pancreatic cancer in relation to region of residence and age. METHOD: The data sources were two nationwide databases: Danish Pancreatic Cancer Database and Danish Palliative Care Database. The study population included patients (18+ years old) diagnosed with pancreatic cancer from 2011 to 2018. We investigated admittance to SPC, and time from diagnosis to referral to SPC and first contact with SPC to death by region of residence and age. RESULTS: In the study period (N = 5851) admittance to SPC increased from 44 to 63%. The time from diagnosis to referral to SPC increased in the study period and overall, the median time was 67 days: three times higher in Southern (92 days) than in North Denmark Region. The median number of days from diagnosis to referral to SPC was lower in patients ≥70 years (59 days) vs patients < 70 years (78 days), with regional differences between the age groups. Region of residence and age were associated with admittance to SPC; highest for patients in North Denmark Region vs Capital Region (OR = 2.03 (95%CI 1.67-2.48)) and for younger patients (< 60 years vs 80+ years) (OR = 2.54 (95%CI 2.05-3.15)). The median survival from admittance to SPC was 35 days: lowest in Southern (30 days) and highest in North Denmark Region (41 days). The median number of days from admittance to SPC to death was higher in patients < 70 years (40 days) vs ≥ 70 years (31 days), with a difference between age groups in the regions of 1-14 days. CONCLUSIONS: From 2011 to 2018 more patients with pancreatic cancer than previously were admitted to SPC, with marked differences between regions of residence and age groups. The persistently short period of time the patients are in SPC raises concern that early integrated palliative care is not fully integrated into the Danish healthcare system for patients with pancreatic cancer, with the risk that the referral comes so late that the patients do not receive the full benefit of the SPC.