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.

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.

Up to 40% of non-smallcell lung cancer (NSCLC) patients develop brain metastases (BMs). The potential benefits of radiotherapy (RT) in patients with poor performance status (PS) are questionable, with considerable risk for futile treatment. We analyzed overall survival after initial radiotherapy in NSCLC patients with BMs, focusing on the relationship between PS and survival after RT. This study reports a prospective observational study including consecutive 294 NSCLC patients with first-time BMs. Overall survival (OS) was calculated from the start of RT to death or last follow-up (1 June 2023). Overall, in the 294 included patients (median age 69 years), the median OS was 4.6 months; 2.5 months after WBRT (n = 141), and 7.5 months after SRT (n = 153). After WBRT, mOS was equally poor for patients with ECOG 2 (1.9 months) and ECOG 3–4 (1.2 months). After SRT, mOS for patients with ECOG 2 was 4.1 months; for ECOG 3 patients, mOS was 4 1.6 months. For NSCLC patients with ECOG 2 diagnosed with BMs who are not candidates for surgery or SRT, WBRT should be questioned due to short survival.

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.Trial registration: Clinical trial information NCT00676936 (13.05.2008)

Background: Undernutrition and cachexia are common in advanced cancer and often linked to systemic inflammation. While inflammation is associated with poorer prognosis, accelerated weight loss, and reduced treatment tolerance, its direct impact on food intake remains insufficiently investigated. Aim: To examine the association between systemic inflammation and energy and protein intake over time in patients with advanced cancer. Methods: A total of 170 patients from the Palliative Radiotherapy and Inflammation Study were included. Nutritional status was assessed using PG-SGA SF. Dietary intake was recorded using repeated 24 h recalls. Systemic inflammation was defined as CRP > 10 mg/L. Mixed linear models were applied to evaluate the association between inflammation energy and protein intake over time. Results: Systemic inflammation (CRP >10 mg/L) was present in 87 (51%) patients and associated with significantly lower energy (−3.6 kcal/kg, p = 0.04) and lower protein intake (−0.25 g/kg, p = 0.003). Patients with inflammation were more often undernourished and had shorter survival. Conclusions: Systemic inflammation is likely associated with clinically relevant reductions in energy and protein intake in advanced cancer. CRP may help identify patients for whom standard nutritional support is insufficient.

Introduction: Radiotherapy (RT) is a frequently offered treatment option for brain metastases (BMs) in patients with non-small-cell lung cancer (NSCLC). This study presents patient-reported outcomes (PROs) in a cohort of NSCLC with BMs treated with RT. This study researched how PRO scores at the start of RT may be useful in survival estimates and how PROs change over time after RT. Methods: NSCLC patients with first-time BMs treated with RT were identified in a prospective observational study. PROs were collected at the start of RT and monthly for up to 1 year. Differences in PRO mean scores at the start of RT (M0) and at month 2 (M2) after treatment are reported. Prognostic values of PROs were analyzed in a stepwise adjusted Cox model. Results: Of 294 patients identified, 239 (81%) responded at M0; 105/239 (44%) responded at both M0 and M2. High scores for weakness of legs at M0 were associated with short survival when adjusting for performance status and status of extracranial metastases. Those responding at M0 only had worse mean scores for overall QoL and PF but similar scores for fatigue and dyspnea compared to patients responding over time. At M2, patients with <6 months survival after RT reported worse scores for overall QoL, PF, fatigue, and dyspnea; long-term survivors reported stable scores. Conclusions: NSCLC patients diagnosed with BMs and expected survival < 6 months should be offered optimal palliative care rather than RT.