Sexual Problems as Late Effects: Awareness and Information Needs Among 1870 Long-term Norwegian Childhood, Adolescent, and Young Adult Cancer Survivors (The NOR-CAYACS Study).

Purpose: Treatment-related sexual problems are common, but understudied, among survivors of Childhood, Adolescent, and Young Adult Cancer Survivors (CAYACS). We investigated awareness of, and information needs regarding, sexual problems as late effects in a nation-wide sample of long-term CAYACS. Methods: Five-year survivors were identified by the Cancer Registry of Norway, diagnosed between 1985 and 2009 with any childhood cancer (0-18 years of age, excluding central nervous system tumors), leukemia, colorectal cancer, breast cancer, non-Hodgkin lymphoma, or malignant melanoma (19-39 years of age). Malignant melanoma survivors treated with local surgery only served as an unmatched reference group. Survivors were mailed a survey, including items on awareness and information needs. Descriptive statistics and logistic regression analyses were used for data analyses. Results: Of 5361 CAYACS invited, 2104 responded (39%), of which 1870 were eligible for inclusion. In all, 62% were aware of sexual problems as late effects (46% aware only, 16% experienced it) and 31% reported information needs. Of all groups, childhood cancer survivors reported the lowest level of awareness (43% aware, 7% experienced it) and the highest information needs (38%). In multivariable models, awareness was associated with higher education, shorter time since treatment, more intense treatments, and experiencing hormonal changes and reduced fertility. Information needs were associated with having experienced sexual problems, female gender, higher treatment intensity, chronic fatigue, and increased depressive symptoms. Conclusions: A substantial proportion of long-term CAYACS report being unaware of, and have information needs regarding sexual problems as late effects decades beyond treatment. Addressing such issues during follow-up care is important.

Chronic fatigue syndromes: real illnesses that people can recover from.

The 'Oslo Chronic Fatigue Consortium' consists of researchers and clinicians who question the current narrative that chronic fatigue syndromes, including post-covid conditions, are incurable diseases. Instead, we propose an alternative view, based on research, which offers more hope to patients. Whilst we regard the symptoms of these conditions as real, we propose that they are more likely to reflect the brain's response to a range of biological, psychological, and social factors, rather than a specific disease process. Possible causes include persistent activation of the neurobiological stress response, accompanied by associated changes in immunological, hormonal, cognitive and behavioural domains. We further propose that the symptoms are more likely to persist if they are perceived as threatening, and all activities that are perceived to worsen them are avoided. We also question the idea that the best way to cope with the illness is by prolonged rest, social isolation, and sensory deprivation.Instead, we propose that recovery is often possible if patients are helped to adopt a less threatening understanding of their symptoms and are supported in a gradual return to normal activities. Finally, we call for a much more open and constructive dialogue about these conditions. This dialogue should include a wider range of views, including those of patients who have recovered from them.

Graft-Versus-Host-Disease and Health-Related Quality of Life in Young Long-term Survivors of Cancer and Allogeneic Hematopoietic Stem Cell Transplantation.

Purpose: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an established treatment predominantly for malignancies. Chronic graft-versus-host disease (cGVHD) is the leading long-term complication after allo-HSCT, but knowledge on cGVHD and health-related quality of life (HRQOL) in long-term survivors of allo-HSCT performed in childhood, adolescence, and young adulthood (CAYA) is scarce. Therefore, we aimed to (1) assess prevalence and risk factors of active cGVHD using the 2014 National Institutes of Health-Consensus criteria, (2) investigate associations between cGVHD severity, patient-reported symptom burden, and HRQOL, and (3) compare HRQOL of survivors to population norms. Methods: We conducted a nationwide cross-sectional study in long-term survivors of CAYA allo-HSCT combining clinical examinations and patient-reported outcome measures. Results: We included 103 survivors, 55 (53%) females, median age of 19.6 years [range 0.3-29.9] at HSCT, 16.8 years [6.0-32.0] from HSCT, and 77 (75%) with underlying malignancy. Overall, 32 (31%) survivors were diagnosed with active cGVHD. The risk of active cGVHD was increased with prior acute GVHD and reduced with in vivo T cell depletion. cGVHD severity was associated with increased symptom burden, but not with adverse HRQOL. Compared to Norwegian population norms, allo-HSCT survivors reported significantly lower HRQOL. Conclusion: These results indicate a high prevalence of cGVHD in long-term survivors of CAYA allo-HSCT. Although we did not find an association between cGVHD severity and HRQOL, survivors reported significantly poorer HRQOL compared to population norms. Knowledge on the long-term consequences of cGVHD will be important for optimizing treatment and long-term follow-up care after CAYA allo-HSCT.

A study of high neuroticism in long-term survivors of childhood, adolescence, and young adult cancers.

Neuroticism is a basic personality trait concerning negative feelings under stressful conditions. Our purpose was to examine the rate of high neuroticism and factors associated with high neuroticism in long-term (≥ 5 years) survivors of childhood, adolescent, and young adult cancer (CAYACSs). Norwegian CAYACSs aged 0-39 years when diagnosed and treated between 1985 and 2009 for cancer in childhood/adolescence (0-18 years), or as young adults (19-39 years) and alive in 2015 were mailed a questionnaire. Data from 1629 CAYACSs (481 children/adolescents and 1148 young adults) were analyzed. High neuroticism was found in 44% of survivors of childhood/adolescent cancers versus 34% in survivors of young adult cancer (p < 0.001). The rate of high neuroticism in female CAYACSs was 40% and in males 30% (p < 0.001). The corresponding difference between male survivor group was non-significant. In multivariable analysis, young age at survey, more adverse effects, poor self-rated health, female sex, chronic fatigue, and increased depression remained significantly associated with high neuroticism. Cancer treatment, comorbidity, and lifestyle were significant in bivariate analyses. Cancer at earlier age could increase the risk of high neuroticism among adult survivors. Screening for neuroticism could identify CAYACSs at risk for experiencing multiple health concerns and needing special follow-up attention.

Sex difference in disease burden of inflammatory arthritis patients treated with tumor necrosis factor inhibitors as part of standard care.

OBJECTIVE: Knowledge is needed on the total disease burden across the sexes in inflammatory arthritis (IA). We aimed to compare disease burden, including a broad range of health aspects, across men and women with IA treated with tumor necrosis factor inhibitors (TNFi). METHODS: Adult outpatients with IA (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) were included as part of standard care. Patient-reported outcomes, disease activity, TNFi trough levels, calprotectin, Work Productivity and Activity Impairment, comorbidities and cardiovascular risk profile were assessed. Unadjusted comparisons across sexes were done with independent t-test, Mann-Whitney U-test and X2-test and adjusted analyses with General Linear Models and logistic/ordinal logistic regression. RESULTS: A total of 305 IA patients were included (167 men, 138 women). A significantly lower proportion of women (45%) than men (59%) were in remission according to disease-specific composite scores (p = 0.02). Women had significantly worse scores on pain, joint pain, fatigue, enthesitis, Health Assessment Questionnaire and Short Form (SF)-36 vitality and social functioning (all p≤0.04). Both sexes had worse SF-36 scale scores than the general population. Women reported more absenteeism (work time missed) and activity impairment. TNFi trough levels, neutralizing antibodies and calprotectin were similar across sexes. A similar total number of comorbidities was seen. Self-reported hypothyroidism was more frequent in women. Men had higher 10-year calculated risk of fatal cardiovascular events. CONCLUSION: Important differences in disease burden between men and women were seen. More attention to sex differences in the follow-up of IA patients is warranted.

From Observation to Action: Developing and Pilot-Testing a Communication Tool for Follow-up Consultations with Adolescent Cancer Survivors.

Purpose: Efficient physician communication with adolescent cancer survivors (ACS) during follow-up consultations is important to enable survivors to take responsibility for their health. The present study had two aims: to develop a communication tool to enhance structured consultations and improve clinician communication in follow-up consultations, and to pilot-test the tool in physicians' consultations with ACS. Methods: Clinicians and communication experts collaborated closely to develop the 7 Memory Hooks (7MH) communication tool and a corresponding coding scheme for scoring communication behavior in consultations. Thirty-seven follow-up consultations between ACS and physicians were video-recorded (22 before intervention and 15 after intervention). The intervention consisted of a didactic lecture, a group workshop, and individual coaching to provide feedback to physicians on the communication skills observed in the pre-intervention videos. We then compared physicians' communication behavior both before and after intervention. Results: Fourteen physicians participated in the 7MH training. The mean total score on the 7MH scheme was significantly higher post-intervention compared with pre-intervention (p = 0.001). Six behaviors changed significantly after the intervention. At a group level, physicians were more likely to be alone with the adolescent (p = 0.004) and to prepare the patient for transition to adult heath care (p = 0.040). They asked more often about the patients' expectations (p = 0.007) and resources ((p = 0.019). And they acknowledged patients' concerns more often (p = 0.016) but talked significantly less about physical activity (p = 0.012). Conclusion: A physician communication tool, designed bottom-up and developed in collaboration with the clinic, shows promising effects on physicians' communication behavior at follow-up consultations with ACS.

A Controlled Study of Major Depressive Episodes in Long-Term Childhood, Adolescence, and Young Adult Cancer Survivors (The NOR-CAYACS Study).

BACKGROUND: A major depressive episode (MDE) is typically self-rated by screening forms identifying probable MDE (pMDE). This population-based cross-sectional questionnaire study examined the prevalence rates of pMDE identified by the PHQ-9 screener in long-term survivors of childhood and adolescence (CACSs) and young adult cancer (YACSs) and a normative sample (NORMs). METHODS: Data from 488 CACSs, 1202 YACSs, and 1453 NORMs were analyzed, and pMDE was defined both by cut-off ≥10 on the total PHQ-9 score and by an algorithm. RESULTS: The prevalence rates of pMDE among CACSs were 21.5%, 16.6% in YACSs, and 9.2% among NORMs using the cut-off definition. With the algorithm, the prevalence rates of pMDE were 8.0% among CACSs, 8.1% among YACSs, and 3.9% among NORMs. Independent of definition, CACSs and YACSs had significantly increased prevalence rates of pMDE compared to NORMs. Psychosocial factors and self-rated health were significantly associated with both definitions of pMDE in multivariable analyses, while survivor groups, cancer types, and adverse events were not. CONCLUSION: Since pMDE has negative health consequences and is amenable to treatment, healthcare providers should be attentive and screen for pMDE in young cancer survivors. For PHQ-9, the preferred type of definition of pMDE should be determined.

Lifestyle among long-term survivors of cancers in young adulthood.

PURPOSE: To investigate lifestyle in a population-based sample of long-term (≥ 5 years since diagnosis) young adult cancer survivors (YACSs), and explore factors associated with not meeting the lifestyle guidelines for physical activity (PA), body mass index (BMI), and smoking. METHODS: YACSs (n = 3558) diagnosed with breast cancer (BC), colorectal cancer (CRC), non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), or localized malignant melanoma (MM) between the ages of 19 and 39 years and treated between 1985 and 2009 were invited to complete a mailed questionnaire. Survivors of localized MM treated with limited skin surgery served as a reference group for treatment burden. RESULTS: In total, 1488 YACSs responded (42%), and 1056 YACSs were evaluable and included in the present study (74% females, average age at survey 49 years, average 15 years since diagnosis). Forty-four percent did not meet PA guidelines, 50% reported BMI ≥ 25 and 20% smoked, with no statistically significant differences across diagnostic groups. Male gender, education ≤ 13 years, comorbidity, lymphedema, pain, chronic fatigue, and depressive symptoms were associated with not meeting single and/or an increasing number of lifestyle guidelines. CONCLUSION: A large proportion of long-term YACSs do not meet the lifestyle guidelines for PA, BMI, and/or smoking. Non-adherence to guidelines is associated with several late effects and/or comorbidities that should be considered when designing lifestyle interventions for YACSs.

Norwegian reference data on the Fatigue Questionnaire and the Patient Health Questionnaire-9 and their interrelationship.

BACKGROUND: Population-based reference data on frequently used questionnaires are important for comparative purposes. Due to changes in health and lifestyles, such data should be updated every other decade. The objectives of this study were to establish Norwegian population-based reference data on the Fatigue Questionnaire (FQ) and the Patient Health Questionnaire-9 (PHQ-9) on depression, to compare the FQ-scores with our previous reference data from 1996, and to explore the relationship between the scores on these two instruments. METHODS: In 2015, a representative sample of 6,012 Norwegians aged 18-80 years was mailed a questionnaire including the FQ and the PHQ-9, and 36% responded. Complete FQ-scores were delivered by 2,041 subjects, and complete PHQ-9 scores by 2,086 subjects. The scores are displayed according to sex and 10-year age groups. RESULTS: Few 2015 mean scores of mental, physical, and total fatigue differed significantly from those of 1996, and the same was found for the prevalence rates of chronic fatigue. The exception was a significantly lower prevalence in 2015 of mean fatigue scores and prevalence of chronic fatigue in females ≥ 60 years. The prevalence of major depressive episode (MDE) based on the PHQ-9 sum score cut-off ≥ 10 was 5.9% for males and 9.8% for females, and 2.5% and 3.8% using a DSM-based algorithm with at least five endorsed criteria including either anhedonia or depressed mood. The correlation between the FQ and the PHQ-9 was 0.59, implying 36% shared variance. CONCLUSIONS: This study showed considerable interrelationship between the FQ and the PHQ-9 constructs. The reference data show that scores on the FQ have only improved significantly in persons aged 60 or more years between 1996 and 2015. Our prevalence findings of MDE based on the PHQ-9 are in accordance with the findings from other countries. The FQ and the PHQ-9 should be used together in epidemiological and clinical studies.

Symptoms in the general Norwegian adult population - prevalence and associated factors.

BACKGROUND: Patients´ own perceptions and evaluations of symptoms, functioning and other health-related factors, i.e. Patient Reported Outcomes (PROs), are important elements for providing good patient care. Symptoms are subjective and best elicited by the patient orally or by using PRO measures (PROMs), be it on paper, or as electronic assessment tools. Reference values on frequently used PROMs facilitate the interpretation of scores for use in clinics and research settings, by comparing patient data with relevant samples from the general population. Study objectives were to (1) present reference values for the M.D. Anderson Symptom Inventory (MDASI) (2) examine the occurrence and intensity of symptoms assessed by the MDASI in a general Norwegian adult population sample, and (3) examine factors associated with higher symptom burden defined as the sum score of all symptoms, and factors associated with symptoms` interference on functions. METHODS: In 2015, MDASI was sent by mail as part of a larger survey, to a representative sample of the general Norwegian adult population (N = 6165). Medical comorbidities were assessed by the Self-Administered Comorbidity Questionnaire. Depression was self-reported on the Patient Health Questionnaire 9 (PHQ-9). Linear multivariable regression analysis was used to examine for factors associated with MDASI sum score and factors associated with symptoms' interference on functions. RESULTS: The response rate was 36%. More women (54%) than men (46%) responded. Mean age was 55 years (SD 14). The most frequent symptoms were fatigue (59.7%), drowsiness (56.2%) and pain (56.1%). Fatigue, pain and disturbed sleep had the highest mean scores. The presence of one or more comorbidities, increasing PHQ-9 score and lower level of education were associated with higher MDASI sum score (p < 0.001). The MDASI sum score and the PHQ-9 score were positively associated with all interference items (p < 0.001) except for walking (p = 0.22). CONCLUSION: This study provides the first Norwegian reference values for MDASI. The presence of one or more comorbidities, higher level of depressive symptoms and lower level of education were significantly associated with higher MDASI sum score. These covariates must be controlled for when using the reference values.

PALLiON - PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care.

BACKGROUND: Several publications have addressed the need for a systematic integration of oncological care focused on the tumor and palliative care (PC) focused on the patient with cancer. The exponential increase in anticancer treatments and the high number of patients living longer with advanced disease have accentuated this. Internationally, there is now a persuasive argument that introducing PC early during anticancer treatment in patients with advanced disease has beneficial effects on symptoms, psychological distress, and survival. METHODS: This is a national cluster-randomized trial (C-RCT) in 12 Norwegian hospitals. The trial investigates effects of early, systematic integration of oncology and specialized PC in patients with advanced cancer in six intervention hospitals compared with conventional care in six. Hospitals are stratified on the size of local catchment areas before randomization. In the intervention hospitals, a three-part complex intervention will be implemented. The backbone of the intervention is the development and implementation of patient-centered care pathways that contain early, compulsory referral to PC and regular and systematic registrations of symptoms. An educational program must be completed before patient inclusion. A total of 680 patients with advanced cancer and one caregiver per patient are included when patients come for start of last line of chemotherapy, defined according to national treatment guidelines. Data registration, clinical variables, and patient- and caregiver-reported outcomes take place every 2 months for 1 year or until death. The primary outcome is use of chemotherapy in the last 3 months of life by comparing the proportion of patients who receive this in the intervention and control groups. Primary outcome is use of chemotherapy in the last 3 months before death, i.e. number of patients. Secondary outcomes are initiation, discontinuation and number of cycles, last 3 months of life, administration of other medical interventions in the last month of life, symptom burden, quality of life (QoL), satisfaction with information and follow-up, and caregiver health, QoL, and satisfaction with care. DISCUSSION: Results from this C-RCT will be used to raise the awareness about the positive outcomes of early provision of specialized palliative care using pathways for patients with advanced cancer receiving medical anticancer treatment. The long-term clinical objective is to integrate these patient-centered pathways in Norwegian cancer care. The specific focus on the patient and family and the organization of a predictable care trajectory is consistent with current Norwegian strategies for cancer care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03088202. Registered on 23 March 2017.

A prospective study of patient reported urinary incontinence among American, Norwegian and Spanish men 1 year after prostatectomy.

OBJECTIVE: To compare pre- and post-radical prostatectomy (RP) responses in the urinary incontinence domain of Expanded Prostate Cancer Index Composite-26 (EPIC-26) in cohorts from the USA, Norway and Spain. METHODS: A prospective study of pre- and 1-year post-treatment responses in American (n=537), Norwegian (n=520) and Spanish (n=111) patients, establishing the prevalence of urinary incontinence defined according to published dichotomization. Thereafter we focused on the response alternatives "occasional dribbling", pad use and problem experience. A multivariate logistic regression analysis (significance level ≤ 0.01) considered risk factors for "not retaining total control". RESULTS: Compared to the European men, the American patients were younger, healthier and more presented with lower risk tumors. Before RP no inter-country differences emerged the prevalence of urinary incontinence (6%). One-year post-treatment urinary incontinence was described by 30% of the American and 41% of the European patients, occasional dribbling being the most frequent type of urinary leakage. In the multivariate analysis the risk of "not retaining total control" increased almost 3-fold in European compared to American patients, with age and co-morbidity being additional independent risk factor. CONCLUSION: After RP patients from Spain and Norway reported more unfavorable outcomes by EPIC-26 than the American patients to most of the urinary incontinence items, the difference between the European and American patients remaining in the multivariate analysis. The most frequent post-RP response alternative "occasional dribbling" needs to be validated with pad weighing as "gold standard".

Prescription of analgesics to long-term survivors of cancer in early adulthood, adolescence, and childhood in Norway: a national cohort study.

Increasing numbers survive cancers in childhood and adolescence. Long-term survivors of cancers in adulthood have increased prevalence of pain and consumption of analgesics. It is not established whether long-term survivors of cancers in childhood and adolescence also have an increased use of analgesics. However, based on increased use of antidepressants and anxiolytics in long-term survivors of cancers in childhood and adolescence, we hypothesized that this group also had increased use of analgesics. Based on data from the 2 nationwide registers, the Cancer Registry of Norway and the Norwegian Prescription Database, a cohort of 5585 (52% males) long-term survivors of cancers in childhood, adolescence, and early adult life was established. Age- and sex-adjusted comparisons were made to the general population. The age-adjusted one-year periodic prevalence of receiving prescriptions of opioids, benzodiazepines, and benzodiazepine-related hypnotics in the study population was increased by 20% to 50%, and the one-year periodic prevalence of receiving prescriptions of gabapentinoids was approximately increased 2-fold compared to the general population. For paracetamol and nonsteroidal anti-inflammatory drugs, no difference was found. For those survivors, who were persistent or high-dose users of opioids, comedication with high doses of benzodiazepines and/or benzodiazepine-related hypnotics was far more common than among persistent and high-dose opioid users in the general population. The high prevalence of gabapentinoids may indicate increased prevalence of neuropathic pain in this group. The high degree of comedication with benzodiazepines and/or benzodiazepine-related hypnotics in survivors on persistent and high-dose opioids might be an indication of problematic opioid use or addiction.

Metabolic analysis of amino acids and vitamin B6 pathways in lymphoma survivors with cancer related chronic fatigue.

Chronic cancer-related fatigue (CF) is a common and distressing condition in a subset of cancer survivors and common also after successful treatment of malignant lymphoma. The etiology and pathogenesis of CF is unknown, and lack of biomarkers hampers development of diagnostic tests and successful therapy. Recent studies on the changes of amino acid levels and other metabolites in patients with chronic fatigue syndrome/myalgic encephalopathy (CFS/ME) have pointed to possible central defects in energy metabolism. Here we report a comprehensive analysis of serum concentrations of amino acids, including metabolites of tryptophan, the kynurenine pathway and vitamin B6 in a well characterized national Norwegian cohort of lymphoma survivors after high-dose therapy and autologous stem cell transplantation. Among the 20 standard amino acids in humans, only tryptophan levels were significantly lower in both males and females with CF compared to non-fatigued survivors, a strikingly different pattern than seen in CFS/ME. Markers of tryptophan degradation by the kynurenine pathway (kynurenine/tryptophan ratio) and activation of vitamin B6 catabolism (pyridoxic acid/(pyridoxal + pyridoxal 5'-phosphate), PAr index) differed in survivors with or without CF and correlated with known markers of immune activation and inflammation, such as neopterin, C-reactive protein and Interleukin-6. Among personal traits and clinical findings assessed simultaneously in participating survivors, higher neuroticism score, obesity and higher PAr index were significantly associated with increased risk of CF. Collectively, these data point to low grade immune activation and inflammation as a basis for CF in lymphoma survivors.

Challenges and Learning Needs for Providers of Advanced Cancer Care: Focus Group Interviews with Physicians and Nurses.

Background: Implementation of integrated oncology and palliative care improves patient outcomes but may represent a demanding task for health care providers (HCPs). Objective: To explore physicians' and nurses' perceived challenges and learning needs in their care for patients with advanced cancer, and to analyze how these perceptions can provide insight on how to improve care for patients with advanced cancer in an integrated care model. Methods: Residents in oncology, oncologists, nurses, and palliative care physicians were recruited to participate in focus group interviews. Six focus group interviews were conducted with 35 informants. Data were analyzed according to principles of thematic analysis. Results: The discussions in the interviews concerned three broad themes: an emphasis on patients' best interest, perceived as hindered by two sets of barriers; unsatisfactory organizational conditions such as time pressure, lack of referral routines, and few arenas for interdisciplinary collaboration, was perceived as one barrier. The other barrier was related to the appraisal of other HCPs' clinical practices. Participating HCPs expressed in general a positive self-view, but were more critical of other HCPs. Conclusion: Currently, implementation of measures to improve care for patients with advanced cancer appears to be challenging due to cultural and organizational factors, and how HCPs perceive themselves and other HCPs. HCPs' perception of challenges in patient care as not related to themselves (externalization) might be an essential obstacle. Interventions targeting both HCP-related and organizational factors are needed. Particularly important are measures aimed at reducing fragmentation and improving collaboration in care.

Employment Status and Work Ability in Long-Term Young Adult Cancer Survivors.

Purpose: In young adult cancer survivors (YACSs) to explore the rate of being nonemployed and having low work ability, and to identify factors associated with these two outcomes. Methods: All Norwegian YACSs (N = 3558) diagnosed at ages 19-39 years and treated between 1985 and 2009 for breast or colorectal cancer, leukemia, non-Hodgkin lymphoma, or melanoma, and alive in 2015, were mailed a questionnaire. The response rate was 42%. For treatment, a minimal surgery-only group (N = 198) was defined as reference group, and 1000 YACSs represented the local, systemic, and systemic plus other treatment groups. Work status was compared with normative data. Results: The sample included 63% females. Median age at survey was 49 years (range 27-65), and median time since first cancer diagnosis was 16 years (range 6-31). At survey, 25% (95% confidence interval [CI]: 22-27) of YACSs were nonemployed, and 38% (95% CI: 35-41) reported low work ability. The rate of being nonemployed was similar to normative data. More female YACSs held disability pension compared with normative data. In multivariable analyses, an increasing number of adverse effects (AEs), cardiovascular diseases, lower basic education, reduced level of self-rated health, and increased level of depression were significantly associated with both being nonemployed and having low work ability. Conclusions: In YACSs surveyed at median 49 years of age, 25% were nonemployed and 38% had low current work ability. An increased mean number of long-term AEs and several other health-related factors were significantly associated with both these outcomes. Health care providers responsible for YACSs should be attentive to such factors and work ability.

Patients with advanced cancer and depression report a significantly higher symptom burden than non-depressed patients.

OBJECTIVE: Clinical observations indicate that patients with advanced cancer and depression report higher symptom burden than nondepressed patients. This is rarely examined empirically. Study aim was to investigate the association between self-reported depression disorder (DD) and symptoms in patients with advanced cancer controlled for prognostic factors. METHOD: The sample included 935 patients, mean age 62, 52% males, from an international multicentre observational study (European Palliative Care Research Collaborative - Computerised Symptom Assessment and Classification of Pain, Depression and Physical Function). DD was assessed by the Patient Health Questionnaire-9 and scored with Diagnostic and Statistical Manual of Mental Disorder-5 algorithm for major depressive disorder, excluding somatic symptoms. Symptom burden was assessed by summing scores on somatic Edmonton Symptom Assessment Scale (ESAS) symptoms, excluding depression, anxiety, and well-being. Item-by-item scores and symptom burden of those with and without DD were compared using nonparametric Mann-Whitney U tests. The relative importance of sociodemographic, medical, and prognostic factors and DD in predicting symptom burden was assessed by hierarchical, multiple regression analyses. RESULT: Patients with DD reported significantly higher scores on ESAS items and a twofold higher symptom burden compared with those without. Factors associated with higher symptom burden were as follows. Diagnosis: lung (ß = 0.15, p < 0.001) or breast cancer (ß = 0.08, p < 0.05); poorer prognosis: high C-reactive protein (ß = 0.08, p < 0.05), lower Karnofsky Performance Status (ß = -0.14, p < 0.001), and greater weight loss (ß = -0.15, p < 0.001); taking opioids (ß = 0.11, p < 0.01); and having DD (ß = 0.23, p < 0.001). The full model explained 18% of the variance in symptom burden. DD explained 4.4% over and above that explained by all the other variables. SIGNIFICANCE OF RESULTS: Depression in patients with advanced cancer is associated with higher symptom burden. These results encourage improved routines for identifying and treating those suffering from depression.

Usability testing of EirV3-a computer-based tool for patient-reported outcome measures in cancer.

PURPOSE: Eir version 3 (V3) is an electronic tool for administration of patient-reported outcome measures (Eir-Patient) that immediately presents patient scores on the physician's computer (Eir-Doctor). Perceived usability is an important determinant for successful implementation. The aim of this study was to answer the following research question evaluated at the cancer outpatient clinics, in the patients' home, and at general practitioners' (GPs) offices: What are the number, type, and severity of usability issues evaluated by the patient (Eir-Patient module) and by the physician (Eir-Doctor module)? METHODS: A usability evaluation using observations, think-aloud sessions, individual interviews and focus group interviews in cancer patients and their physicians was conducted. Identified usability issues were graded on a severity scale from 1 (irritant) to 4 (unusable). RESULTS: Overall, 73 Eir registrations were performed by 37 patients, and used by 17 physicians in clinical consultations. All patients were able to complete the Eir-Patient symptom registration. Seventy-two usability issues were identified. None of them were graded as unusable. For the Eir-Patient module, 62% of the identified usability issues was graded as irritant (grade 1), 18% as moderate (grade 2), and 20% as severe (grade 3). For the Eir-Doctor module, 46% of the identified usability issues were graded as irritant, 36% as moderate and 18% as severe. CONCLUSIONS: In the updated Eir version, issues in the severe and moderate categories have been changed, to optimize the usability of using real-time PROMs in clinical practice.

The Palliative Radiotherapy and Inflammation Study (PRAIS) - protocol for a longitudinal observational multicenter study on patients with cancer induced bone pain.

BACKGROUND: Radiation therapy (RT) results in pain relief for about 6 of 10 patients with cancer induced bone pain (CIBP) caused by bone metastases. The high number of non-responders, the long median time from RT to pain response and the risk of adverse effects, makes it important to determine predictors of treatment response. Clinical features such as cancer type, performance status and pain intensity, and biomarkers for osteoclast activity are proposed as predictors of response to RT. However, results are inconsistent and there is a need for better predictors of RT response. A similar argument can be stated for the development of cachexia; there are currently no predictors that can identify patients who will develop cachexia later in the cancer disease trajectory. Experimental and preclinical studies show that pain, depression and cachexia are related to inflammation. However, it is not known if inflammatory biomarkers can predict CIBP, depression or development of cachexia. METHODS: This multicenter, multinational longitudinal observational study will include 600 adult patients receiving RT for CIBP. Demographic data, clinical variables, osteoclast and inflammatory biomarkers will be assessed before start of RT, and 3, 8, 16, 24 and 52 weeks after last course of RT. The primary aim of the study is to identify potential predictors for pain relief from RT. Secondary aims are to explore potential predictors for development of cachexia, the longitudinal relationship between pain intensity and depression, and if inflammatory biomarkers are associated with changes in pain intensity, cachexia and depression during one-year follow up. DISCUSSION: The immediate clinical implication of the PRAIS study is to identify potential predictive factors for a RT response on CIBP, and thereby reduce non-efficacious RT. Patient benefits are fewer hospital visits, reduced risk of adverse effects and more individualized pain treatment. The long-term clinical implication of the PRAIS study is to improve the knowledge about inflammation in relation to CIBP, cachexia and depression and potentially identify associations and mechanisms that can be targeted for treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT02107664 , date of registration April 8, 2014 (retrospectively registered). TRIAL SPONSOR: The European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, NTNU, Faculty of medicine and Health Sciences, Trondheim, N-7491, Norway.

Health-related quality of life in patients with psoriatic and rheumatoid arthritis: data from the prospective multicentre NOR-DMARD study compared with Norwegian general population controls.

OBJECTIVES: To compare (1) Short Form-36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS), scale scores and Short Form-6 dimensions (SF-6D) between patients with rheumatoid arthritis (RA) and patients with psoriatic arthritis (PsA) and Norwegian general population controls and (2) improvements in these measures between patients with RA and PsA. METHODS: Analyses of covariance were performed to compare SF-36 measures between first-time enrolled patients with RA (n=3898) and PsA (n=1515) from the prospective observational multicentre NORwegian-Disease Modifying Anti-Rheumatic Drug study (6 months follow-up) and general population controls (n=2323). RESULTS: In age and gender-adjusted analyses, patients with PsA compared with patients with RA had similar PCS, MCS and SF-6D (p≥0.14), worse vitality and general health, but better physical functioning at 0/6 months (p≤0.03). With additional 28-joint disease activity scores adjustment as a proxy for joint inflammation, PCS, most scale scores and SF-6D were worse in patients with PsA than patients with RA at 0/3/6 months (p≤0.01). PCS was more impaired than MCS both in RA and PsA compared with general population controls (p≤0.001). Mean 3-month and 6-month improvements after disease-modifying anti-rheumatic drug treatment were larger in patients with RA than patients with PsA for bodily pain, vitality and mental health (p≤0.02). CONCLUSIONS: Health-related quality of life was overall similar in patients with RA and patients with PsA-with a tendency to worse scores in PsA-and worse compared with Norwegian general population controls.