Using process indicators to monitor documentation of patient-centred variables in an integrated oncology and palliative care pathway—results from a cluster randomized trial

Background. Despite robust evidence from randomized controlled trials (RCTs) demonstrating clinical and patient-reported benefits of integrated oncology and palliative care, the tumour-centred focus is predominant. This single–centre process evaluation monitors documentation of required patient-centred variables during an RCT. Methods. Performance status, patient self-reported symptoms, weight and summaries to general practitioners were assessed from June 2017 to July 2020 in three consultation types: first oncological after study inclusion and palliative and oncological consultations during chemotherapy. Descriptive statistics were used to monitor if the pre-defined program fulfilment of ≥85% documentation was reached. Results. 435 consultations were monitored in 76 patients; 60.5% males, 86.8% with GI cancers; 76 (17.5%) were from the first oncological consultations, 87 (20.0%) and 272 (62.5%) from palliative or subsequent oncological consultations. Program fulfilment differed across consultation types with 94.8% in the palliative consultations (83.3–100%), relative to 65.8% (62.5–75.0%) and 69.2% (57.0–84.3%) for first and subsequent oncological consultations over time, respectively. Use of self-reported symptoms was consistently lower in the oncological consultations. Conclusions. The documentation level of required core variables was not satisfactory, notwithstanding their high clinical relevance and continuous reminders during study. Pre-trial optimization strategies are paramount to promote integration and reduce professional and personal barriers towards a more patient-centred focus

Surgery for brain metastases – real-world prognostic factors’ association with survival

Background Surgical resection of brain metastases (BM) improves overall survival (OS) in selected patients. Selecting those patients likely to benefit from surgery is challenging. The Graded Prognostic Assessment (GPA) and the diagnosis-specific Graded Prognostic Assessment (ds-GPA) were developed to predict survival in patients with BM, but not specifically to guide patient selection for surgery. Our aim was to evaluate the feasibility of preoperative GPA/ds-GPA scores and assess variables associated with OS. Methods We retrospectively reviewed first-time surgical resection of BM from solid tumors at a Norwegian regional referral center from 2011 to 2018. Results Of 590 patients, 51% were female and median age was 63 years. Median OS was 10.3 months and 74 patients (13%) died within three months after surgery. Preoperatively tumor origin was unknown in 20% of patients. A GPA score could be calculated for 92% of the patients preoperatively, but could not correctly predict survival. A ds-GPA score could be calculated for 46% of patients. Multivariable regression analysis revealed shorter OS in patients with higher age, worse functioning status, colorectal primary cancer compared to lung cancer, presence of extracranial metastases, and more than four BM. Patients with preoperative progressive extracranial disease or synchronous BM had shorter OS compared to patients with stable extracranial disease. Conclusion Ds-GPA could be calculated in less than half of patients preoperatively and GPA poorly identified patients which had minimal benefit of surgery. Including status of extracranial disease improve prognostication and therefore selection to surgery for brain metastases

Surgery for brain metastases – real-world prognostic factors’ association with survival

Background Surgical resection of brain metastases (BM) improves overall survival (OS) in selected patients. Selecting those patients likely to benefit from surgery is challenging. The Graded Prognostic Assessment (GPA) and the diagnosis-specific Graded Prognostic Assessment (ds-GPA) were developed to predict survival in patients with BM, but not specifically to guide patient selection for surgery. Our aim was to evaluate the feasibility of preoperative GPA/ds-GPA scores and assess variables associated with OS. Methods We retrospectively reviewed first-time surgical resection of BM from solid tumors at a Norwegian regional referral center from 2011 to 2018. Results Of 590 patients, 51% were female and median age was 63 years. Median OS was 10.3 months and 74 patients (13%) died within three months after surgery. Preoperatively tumor origin was unknown in 20% of patients. A GPA score could be calculated for 92% of the patients preoperatively, but could not correctly predict survival. A ds-GPA score could be calculated for 46% of patients. Multivariable regression analysis revealed shorter OS in patients with higher age, worse functioning status, colorectal primary cancer compared to lung cancer, presence of extracranial metastases, and more than four BM. Patients with preoperative progressive extracranial disease or synchronous BM had shorter OS compared to patients with stable extracranial disease. Conclusion Ds-GPA could be calculated in less than half of patients preoperatively and GPA poorly identified patients which had minimal benefit of surgery. Including status of extracranial disease improve prognostication and therefore selection to surgery for brain metastases

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 (β = 0.15, p < 0.001) or breast cancer (β = 0.08, p < 0.05); poorer prognosis: high C-reactive protein (β = 0.08, p < 0.05), lower Karnofsky Performance Status (β = −0.14, p < 0.001), and greater weight loss (β = −0.15, p < 0.001); taking opioids (β = 0.11, p < 0.01); and having DD (β = 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

The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial

Purpose: Although corticosteroids are frequently used in patients with advanced cancer, few studies have examined the impact of these drugs on patient-reported sleep. We aimed to examine the short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer. Methods: Patient-reported sleep was a predefined secondary outcome in a prospective, randomized, placebo-controlled, double-blind trial that evaluated the analgesic efficacy of corticosteroids in advanced cancer patients (18+), using opioids, and having pain ≥ 4 past 24 h (NRS 0-10). Patients were randomized to the methylprednisolone group with methylprednisolone 16 mg × 2/day or placebo for 7 days. The EORTC QLQ-C30 (0-100) and the Pittsburgh Sleep Quality Index questionnaire (PSQI) (0-21) were used to assess the impact of corticosteroids on sleep at baseline and at day 7. Results: Fifty patients were randomized of which 25 were analyzed in the intervention group and 22 in the control group. Mean age was 64 years, mean Karnofsky performance status was 67 (SD 13.3), 51% were female, and the mean oral daily morphine equivalent dose was 223 mg (SD 222.77). Mean QLQ-C30 sleep score at baseline was 29.0 (SD 36.7) in the methylprednisolone group and 24.2 (SD 27.6) in the placebo group. At day 7, there was no difference between the groups on QLQ-C30 sleep score (methylprednisolone 20.3 (SD 32.9); placebo 28.8 (SD 33.0), p = 0.173). PSQI showed similar results. Conclusions: Methylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer

Inflammatory Markers and Radiotherapy Response in Patients With Painful Bone Metastases

Context Inflammation is proposed to influence tumor response in radiotherapy (RT). Clinical studies to investigate the relationship between inflammatory markers and RT response is warranted to understand the variable RT efficacy in patients with painful bone metastases. Objectives To evaluate the association between inflammatory markers and analgesic response to RT in patients with painful bone metastases. Methods Adult patients from 7 European study sites undergoing RT for painful bone metastases were included in this prospective and longitudinal analysis. The association between RT response and 17 inflammatory markers at baseline, as well as the association between RT response and the changes observed in inflammatory markers between baseline and three and eight weeks after RT, was analyzed with univariate regression analyses. Baseline analyses were adjusted for potential clinical predictors of RT response. Results None of the inflammatory markers were significantly associated with an upcoming RT response in the analysis of 448 patients with complete baseline data. In patients available for follow-up, the three-week change in TNF (P 0.017), IL-8 (P 0.028), IP-10 (P 0.032), eotaxin (P 0.043), G-CSF (P 0.033) and MCP-1 (P 0.002) were positively associated with RT response, while the three-week change in CRP (P 0.006) was negatively associated. Conclusion Results from this study show an association between RT response and change in pro-inflammatory mediators and indicate that inflammation may be important to achieve an analgesic RT response in patients with painful bone metastases. None of the investigated inflammatory markers were found to be pre-treatment predictors of RT response

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 (β = 0.15, p < 0.001) or breast cancer (β = 0.08, p < 0.05); poorer prognosis: high C-reactive protein (β = 0.08, p < 0.05), lower Karnofsky Performance Status (β = −0.14, p < 0.001), and greater weight loss (β = −0.15, p < 0.001); taking opioids (β = 0.11, p < 0.01); and having DD (β = 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

Norwegian reference values for the Short-Form Health Survey 36: development over time

Purpose Reference values for patient-reported outcome measures are useful for interpretation of results from clinical trials. The study aims were to collect Norwegian SF-36 reference values and compare with data from 1996 to 2002. Methods In 2015, SF-36 was sent by mail to a representative sample of the population (N = 6165). Time trends and associations between background variables and SF-36 scale scores were compared by linear regression models. Results The 2015 response rate was 36% (N = 2118) versus 67% (N = 2323) in 1996 and 56% (N = 5241) in 2002. Only 5% of the youngest (18–29 years) and 27% of the oldest (>70 years) responded in 2015. Age and educational level were significantly higher in 2015 relative to 1996/2002 (p < .001). The oldest age group in 2015 reported better scores on five of eight scales (p < 0.01), the exceptions being bodily pain, vitality, and mental health compared to 1996/2002 (NS). Overall, the SF-36 scores were relatively stable across surveys, controlled for background variables. In general, the most pronounced changes in 2015 were better scores on the role limitations emotional scale (7.4 points, p < .001) and lower scores on the bodily pain scale (4.6 points, p < .001) than in the 1996/2002 survey. Conclusions The low response rate in 2015 suggests that the results, especially among the youngest, should be interpreted with caution. The high response rate among the oldest indicates good representativity for those >70 years. Despite societal changes in Norway the past two decades, HRQoL has remained relatively stable