Patient-reported outcome measures for emotional functioning in cancer patients: Content comparison of the EORTC CAT Core, FACT-G, HADS, SF-36, PRO-CTCAE, and PROMIS instruments.

BACKGROUND: Cancer and its treatment can have substantial impact on patients' emotional functioning. Several patient-reported outcome measures (PROMs) assessing emotional functioning are available, but differences in content limit the comparability of results. To better understand conceptual (dis)similarities, we conducted a content comparison of commonly used PROMs. METHODS: We included emotional functioning items, scales, and item banks from the EORTC CAT Core, EORTC QLQ-C30, FACT-G, Hospital anxiety and depression scale (HADS), SF-36, PRO-CTCAE, and PROMIS (item banks for anxiety, depression, and anger). Item content was linked to the International Classification of Functioning, Disability, and Health (ICF) and a hierarchical framework established for PROMIS. Single items could be coded with more than one ICF category but were solely assigned to one facet within the PROMIS framework. RESULTS: The measures comprise 132 unique items covering the ICF components 'Body functions' (136/153 codings, 88.9%) and 'Activities and participation' (15/153, 9.8%). Most ICF codings (112/153, 73.2%) referred to the third-level category 'b1528 Emotional functions, other specified'. According to the PROMIS framework 48.5% of the items assessed depression (64/132 items), followed by anxiety (41/132, 31.1%) and anger (26/132, 19.7%). The EORTC measures covered depression, anxiety, and anger in a single measure, while the PROMIS inventory provides separate item banks for these concepts. The FACT-G, SF-36, PRO-CTCAE and HADS covered depression and anxiety, but not anger. CONCLUSION: Our results provide an in-depth conceptual understanding of selected PROMs and important qualitative information going beyond psychometric evidence. Such information supports the identification of PROMs for which scores can be meaningfully linked with quantitative methods.

Size and composition of family networks of decedents: A nationwide register-based study.

BACKGROUND: Seriously ill individuals rely heavily on family caregivers at the end of life. Yet many do not have family support. AIM: To characterize the size and composition of decedents' family networks by cause of death, demographic, clinical, socioeconomic, and geographic characteristics. DESIGN: A cross-sectional population-level study with data collected from nation-wide registers. SETTING/PARTICIPANTS: All adults in Denmark born between 1935 and 1998 who died of natural causes between 2009 and 2016 were linked at the time of death to living adult spouses/partners, children, siblings, parents, and grandchildren. RESULTS: Among 175,755 decedents (median age: 68 years, range: 18-81 years), 61% had a partner at the time of death and 78% had at least one adult child. Ten percent of decedents had no identified living adult family members. Decedents with family had a median of five relatives. Males were more likely to have a spouse/partner (65%) than females (56%). While 93% of decedents dying of cancer had adult family, only 70% of individuals dying of dementia had adult family at the time of death. The majority of cancer decedents co-resided or lived within 30 km of family (88%), compared to only 65% of those dying from psychiatric illness. CONCLUSIONS: While the majority of adults had an extensive family network at the time of death, a substantial proportion of decedents had no family, suggesting the need for non-family based long-term service and support systems. Assessment of family networks can expand our understanding of the end-of-life caregiving process and inform palliative care delivery.

Conceptualizing patient empowerment in cancer follow-up by combining theory and qualitative data.

BACKGROUND: Patient empowerment (PE) may be defined as the opportunity for patients to master issues important to their own health. The aim of this study was to conceptualize PE and how the concept manifests itself for cancer patients attending follow-up, in order to develop a relevant and sensitive questionnaire for this population. MATERIAL AND METHODS: A theoretical model of PE was made, based on Zimmerman's theory of psychological empowerment. Patients who were in follow-up after first line treatment for their cancer (n = 16) were interviewed about their experiences with follow-up. A deductive thematic analysis was conducted to contextualize the theory and find concrete manifestations of empowerment. Data were analyzed to find situations that expressed empowerment or lack of empowerment. We then analyzed what abilities these situations called for and we further analyzed how these abilities fitted Zimmerman's theory. RESULTS: In all, 16 patients from two different hospitals participated in the interviews. PE in cancer follow-up was conceptualized as: (1) the perception that one had the possibility of mastering treatment and care (e.g. the possibility of 'saying no' to treatment and getting in contact with health care when needed); (2) having knowledge and skills regarding, for example treatment, care, plan of treatment and care, normal reactions and late effects, although knowledge and information was not always considered positively; and (3) being able to make the health care system address one's concerns and needs and, for some patients, also being able to monitor one's treatment, tests and care. CONCLUSION: We conceptualized PE based on Zimmerman's theory and empirical data to contextualize the concept in cancer follow-up. When developing a patient reported outcome measure measuring PE for this group of patients, one needs to be attentive to differences in wishes regarding mastery.

Danish population-based reference data for the EORTC QLQ-C30: associations with gender, age and morbidity.

PURPOSE: General population reference data are useful in the interpretation of health-related quality of life (HRQoL) results, but for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), such data have been published for only seven countries. In 1992, Danish general population data were collected from women only for EORTC QLQ-C30 version 1. Since no Danish reference data exists for men and women for the QLQ-C30 version 3.0, the aims of this study were to generate such data and to investigate the associations between EORTC QLQ-C30 outcomes and age, gender and morbidity, as well as trends over time. METHODS: An age- and gender-stratified random sample of 3,080 Danes was drawn from the Danish Civil Registration System. The EORTC QLQ-C30 was administered electronically and by mail along with a short questionnaire concerning socio-demographics/morbidity. RESULTS: Responses were obtained from 1,832 individuals (60.1% of 3,009 eligible individuals). Response rates varied across age groups, ranging from 41.9% (20-29 years) to 76.1% (70-79 years). The majority of subscales were strongly associated with age and morbidity. Between genders only small, but clinically meaningful and statistically significant differences were found in five out of fifteen scales. When comparing Danish women 20 years ago and today, a tendency toward slightly improved function/reduced symptoms was observed, but the differences were small and statistically significant in only three subscales. CONCLUSION: This study is the first to present Danish general population reference values for the EORTC QLQ-C30 version 3.0. Age and morbidity are important potential confounders that must be taken into account in HRQoL studies.

Advance care planning-family carer psychological distress and involvement in decision making: the ACTION trial.

OBJECTIVES: Facilitated advance care planning (ACP) helps family carers' to be aware of patient preferences. It can improve family carers' involvement in decision making and their overall experiences at the end of life, as well as, reduce psychological stress. We investigated the effects of the ACTION Respecting Choices (RC) ACP intervention on the family carers' involvement in decision making in the last 3 months of the patients' life and on the family carers' psychological distress after 3 months of bereavement. METHODS: Over six European countries, a sample of 162 bereaved family carers returned a bereavement questionnaire. Involvement in decision making was measured with a single item of the Views of Informal Carers-Evaluation of Services Short Form questionnaire. Psychological distress was measured with the Impact of Event Scale (IES). RESULTS: No significant effect was found on family carers involvement in decision making in the last 3 months of the patients' life (95% CI 0.449 to 4.097). However, the probability of involvement in decision making was slightly higher in the intervention arm of the study (89.6% vs 86.7%; OR=1.357). Overall, no statistical difference was found between intervention and control group regarding the IES (M=34.1 (1.7) vs 31.8 (1.5); (95% CI -2.2 to 6.8)). CONCLUSION: The ACTION RC ACP intervention showed no significant effect on family carers' involvement in decision making or on subsequent psychological distress. More research is needed about (1) how family carers can be actively involved in ACP-conversations and (2) how to prepare family carers on their role in decision making. TRIAL REGISTRATION NUMBER: International Standard Randomised Controlled Trial Number ISRCTN17231.

Clustering of EORTC QLQ-C30 health-related quality of life scales across several cancer types: Validation study.

INTRODUCTION: The European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) measures 15 health-related quality of life (HRQoL) scales relevant to the disease and treatment of patients with cancer. A study by Martinelli (2011) demonstrated that these scales could be grouped into three main clusters: physical, psychological and gastrointestinal. This study aims to validate Martinelli's findings in an independent dataset and evaluate whether these clusters are consistent across cancer types and patient characteristics. METHODS: Pre-defined criteria for successful validation were three main clusters should emerge with a minimum R-squared value of 0.51 using pooled baseline-data. A cluster analysis was performed on the 15 QLQ-C30 HRQoL-scales in the overall dataset, as well as by cancer type and selected patient characteristics to examine the robustness of the results. RESULTS: The dataset consisted of 20,066 patients pooled across 17 cancer types. Overall, three main clusters were identified (R2 = 0.61); physical-cluster included role-functioning, physical-functioning, social-functioning, fatigue, pain, and global-health status; psychological-cluster included emotional-functioning, cognitive-functioning, and insomnia; gastro-intestinal-cluster included nausea/vomiting and appetite loss. The results were consistent across different levels of disease severity, socio-demographic and clinical characteristics with minor variations by cancer type. Global-health status was found to be strongly linked to the scales included in the physical-functioning-related cluster. CONCLUSION: This study successfully validated prior findings by Martinelli (2011): the QLQ-C30 scales are interrelated and can be grouped into three main clusters. Knowing how these multidimensional HRQoL scales are related to each other can help clinicians and patients with cancer in managing symptom burden, guide policymakers in defining social-support plans and inform selection of HRQoL scales in future clinical trials.

[Integration af specialiseret palliation og onkologi].

Palliative care (PC) is an approach, which improves the quality of life (QoL) of patients and their families facing problems associated with life-threatening illness. Hospital-based specialised PC alongside cancer treatment shows better symptom management, QoL, satisfaction with care, and less psychological distress. Strong recommendations have been given to integrate PC and cancer care. Systematic screening of symptoms and needs, use of standardised care pathways, better competencies in PC at all levels, more research and palliative medicine as a new speciality in Denmark are future perspectives.

Clinical research in cancer palliative care: a metaresearch analysis.

OBJECTIVE: This metaresearch of the clinicaltrials.gov database aims to evaluate how clinical research on palliative care is conducted within the setting of advanced cancer. METHODS: Clinicaltrials.gov was searched to identify registered studies recruiting patients with cancer, and investigating issues relevant to palliative care. The European Organisation for Research and Treatment of Cancer QLQ-C15-PAL (Quality of Life in palliative cancer care patients) questionnaire was taken into account to define the research domains of interest. Studies investigating cancer-directed therapy, management of cancer treatment-related adverse events and diagnostic tests were excluded. Publication status was crosschecked using PubMed. RESULTS: Of 3950 identified studies, 514 were included. The most frequent reason for exclusion was cancer-directed therapy (2491). In 2007-2012, 161 studies were registered versus 245 in 2013-2018. Included studies were interventional (84%) or observational (16%). Most studies were monocentric (60%), sponsored by academia (79%), and conducted in North America (57%) or Europe (25%). Seventy-nine per cent of studies evaluated a heterogeneous population (>1 tumour type). Interventional studies most frequently investigated systemic drugs (34%), behavioural interventions (29%) and procedures for pain (24%). Pain, quality of life and physical function were the most frequently studied research domains (188, 95 and 52 studies, respectively). The most applied primary outcome measures were efficacy/symptom control (61%), quality of life (14%) and feasibility (12%). Only 16% of the closed studies had published results in PubMed. CONCLUSIONS: Our study describes the heterogeneous landscape of studies conducted to address the issues of patients with advanced cancer in palliative care. Albeit the observed increase in the number of studies over the last decade, the generalisation of the results brought by the existing trials is limited due to methodological issues and lack of reporting. A greater effort is needed to improve clinical research that supports evidence-based palliative cancer care.

Danish medical schools do not meet international recommendations for teaching palliative medicine.

INTRODUCTION: Denmark has been ranked low regarding the extent of teaching in palliative care (PC) at medical schools although the Danish Health Authority recommends that all doctors have basic knowledge of PC. The aim of this study was to investigate the contents of and time spent on teaching in PC at the four Danish medical schools and to compare results with recommendations from the European Association of Palliative Care (EAPC). METHODS: Data were collected by examining university curricula, course catalogues, etc., using search words based on recommendations from the Palliative Education Assessment Tool and by a questionnaire survey among the university employees responsible for semesters or courses in Danish medical schools. RESULTS: Teaching in palliative medicine at Danish medical schools is generally sparse and mainly deals with pain management and general aspects of PC. Compared to European recommendations, teaching in, e.g., ethics, spirituality, teamwork and self-reflection is lacking. Furthermore, PC training does not reach the recommended minimum of 40 hours, and examinations in PC are not held. As from the autumn of 2017, the University of Southern Denmark has offered a course that expands teaching in PC and thereby improves compliance with EAPC recommendations; the remaining three medical schools do not, to our knowledge, have any specific plans to increase the extent of teaching activities in palliative medicine. CONCLUSIONS: Teaching in palliative medicine is sparse at all four medical schools in Denmark and should be strengthened to meet Danish as well as European recommendations. FUNDING: No funding was used for this study. TRIAL REGISTRATION: not relevant.

[Care and treatment can be planned in advance with advance care planning].

Advance care planning (ACP) is a discussion between an incurably ill patient, a healthcare professional and if possible, a relative about preferences for end-of-life care, and ACP may improve the communication in this situation. However, in the Danish healthcare system there is no formalized and systematically used standard procedure for discussions with patients about their knowledge of their treatment options, values and preferences. In this article we review the concept of ACP, including definition, experiences from abroad and the status of ACP in Denmark.

[Coherent palliative effort in health care]. / Sammenhængende palliativ indsats i sundhedsvæsenet.

Effective palliative care requires continuous contact, exchange of information, and mutual professional respect between all the relevant health-care professionals. At least one of the professionals should coordinate care. Many patients with advanced cancer report uncovered palliative care needs. In order to assure that all cancer patients receive optimal palliative care, earlier initiation and better integration of basic palliative care (at hospitals and in primary care) and specialist palliative care teams are needed.

[Quality of life more than five years after breast cancer--secondary publication]. / Livskvalitet mere end fem år efter brystkraeft--sekundaerpublikation.

In this national survey, long-term breast cancer survivors (BCS) (n = 1,316) reported quality of life comparable to data from the general Danish female population, but a significantly higher prevalence of chronic pain (42% versus 32%). Paraesthesia, phantom sensation, allodynia, and swelling of arm/shoulder were also reported, and every fifth woman felt that these sequelae limited her daily activities. Health care utilization indicated chronic morbidity. Relatively young age, short education, and former radiotherapy were risk factors for issues such as pain.

[Personal health contact systems for cancer patients in Danish hospital wards]. / Kontaktpersonordninger til kraeftpatienter på danske hospitalsafdelinger.

INTRODUCTION: We examined personal health contact systems for cancer patients in Danish hospital wards and investigated whether there is a relation between patients' experience of having a personal health contact and the presence of a health contact system. MATERIAL AND METHODS: The personal health contact systems were examined by means of a questionnaire survey. Data from the questionnaire were combined with data from an earlier questionnaire study on cancer patients' needs to examine the relation between patients' experience of having a personal health contact and the presence of a health contact system. RESULTS: The majority of hospital wards included in the study had introduced a personal health contact system, but the time of implementation and specific organization of the systems vary. We found a statistically significant relation between the presence of personal health contact systems and patients' experience of having a personal health contact, but it was weak. CONCLUSION: Although most hospital wards have introduced personal health contact systems, their actual impact has been limited.

[Quality of life research methodology]. / Metoder i livskvalitetsforskning.

An elaborated research methodology elucidating the scientific quality of health-related quality of life questionnaires has been developed. With the availability of a methodology that can investigate important aspects of the validity and reliability of questionnaires, the central question is no longer whether questionnaire based studies are valid, but to what extent their validity in specific applications has been sufficiently researched. Newer statistical methods will facilitate a shift towards interactive, individualized questionnaires.

[Health-related quality of life in cancer patients]. / Helbredsrelateret livskvalitet ved kraeft.

The article reviews methods, experiences, and results of quality of life research in cancer, and presents recommendations. The research has comprised descriptive studies, end-points in clinical trials, prognostic studies, and clinical applications of quality of life questionnaires. There is a need for additional quality of life studies in relation to all cancer sites and treatments but such studies should be undertaken only when the necessary resources are available, as only well-conducted studies are of value.

[Measurement of health-related quality of life in thyroid patients]. / Måling af helbredsrelateret livskvalitet hos patienter med thyroideasygdomme.

Few studies describing the health-related quality of life (HRQL) in thyroid patients have been published and a validated thyroid-specific HRQL measure is lacking. Studies indicate reduced HRQL in thyroid patients, but the studies are small or methodologically weak. Many clinically-relevant questions about HRQL and thyroid disease remain unanswered and the current sparse results are contradictory. This may be due to the lack of a valid HRQL measurement. Hopefully, increased focus on HRQL and the development of a valid thyroid-specific HRQL measure will improve this status.

[Research in palliative care]. / Forskning i palliativ indsats.

Research in palliative care is developing rapidly. It includes several research disciplines, e.g. basic research investigating the pathophysiology of symptoms such as pain and fatigue, clinical trials, epidemiology, health services research, nursing research, research into psychosocial, existential, spiritual, and psychiatric issues, methodological research, and research into problems encountered by carers. Different methods are often combined. The research has mainly involved cancer patients but research in palliative care related to other diagnoses is increasing.