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Background: Patients with advanced cancer and bone metastases may have unmet palliative care needs that go unnoticed during clinical oncological practice. This observational study describes palliative care needs and interventions identified because of participation in a clinical study. Methods: Patients with advanced cancer and painful bone metastases included in the Palliative Radiotherapy and Inflammation Study (PRAIS) aiming to predict the response of radiotherapy (RT) were eligible. All patients met with the palliative care (PC) study team prior to start of RT, after they had completed patient reported outcome measures (PROMs). Symptoms prompting interventions by the study team were documented in the patient charts and reviewed.Results: One hundred-and thirty-three patients were reviewed; 63% males, mean age 65 and mean Karnofsky score (KPS) 73. Interventions were initiated in 50% (n=67) of the patients. Most common were changed opioid management (69%), treatment of constipation (43%) and nausea (24%) and nutritional advices (21%). Patients receiving interventions had lower mean KPS (70 vs 77 p Conclusions: Adverse symptoms are often not identified in routine oncological consultations prior to RT for cancer pain. Special attention should be directed to frail patients. These findings call for an early and systematic integration of palliative care in patients with advanced cancer.Trial registration: ClinicalTrials.gov NCT02107664

Background Radiationtherapy (RT) provide pain reduction in about 60% of patients with painful bone metastases. Studies have identified demographic and clinical characteristics to predict RT response, but no model is clinical useful. Tumor characteristics and inflammation can influence cancer induced bone pain, but the association with RT response are not studied. We test if tumor characteristics and the inflammation marker CRP improve prediction of RT response. Methods We included adult patients receiving RT for painful bone metastases in a multicenter, multinational longitudinal observational study. The primary endpoint was analgesic response within 8 weeks after RT defined according to current guidelines. Seventeen independent potential predictor variables assessed at baseline included patient demographics, RT administration, pain characteristics and treatment, cancer diagnosis, tumor characteristics, depression and inflammation (CRP). Multivariate logistic regression analysis with multiple imputation of missing data were applied to identify predictors of RT response. Results are reported as odds ratios (OR) and 95% confidence intervals (CI). Results 565 eligible patients were enrolled, 424 patients (75%) had complete data on the variables of interest and multiple imputation allowed the final regression models to be carried out on 513 patients (91%). 232 patients (41%, CI 37%-45%) responded to RT. Higher Karnofsky performance status (OR 1.45, CI 1.21-1.73), breast cancer (OR 2.61, CI 1.20-5.69) and prostate cancer (OR 2.64, CI 1.24-5.63) (compared to GI cancer), presence of soft tissue expansion (OR 1.78, CI 1.13-2.81) and higher maximum pain intensity at the radiated site (OR 1.1, CI 1.00-1.21) were significant predictors of positive RT response, while the use of steroids was a negative predictor (OR 0.62, CI 0.42-0.93). The discriminative ability of the model was moderate, with C-statistics 0.70. Conclusions This study supports previous findings that higher performance status, cancer diagnosis and higher baseline pain intensity predict analgesic RT response. The study presents new data showing that presence of soft tissue expansion predicts RT response and that CRP is not significantly associated with analgesic RT response. Clinical trial identification NCT02107664 (Date of registration April 8, 2014). Legal entity responsible for the study Pal Klepstad. Funding The European Palliative Care Research Centre (PRC). Disclosure All authors have declared no conflicts of interest.

Purpose Breast cancer survivors may experience pain, fatigue, or psychological distress as a result of the treatment. These symptoms may co-occur and form a cluster. However little is known about symptom clusters (SCs) in long-term breast cancer survivors. This study aimed to identify subgroups of breast cancer survivors with the SC of pain, fatigue, and psychological distress, and to examine sociodemographic and clinical characteristics associated with this SC. Methods Data were obtained from a nationwide survey of breast cancer survivors (N = 834). Exhaustive enumeration of possible combination of the three binary variables (pain, fatigue, psychological distress) was conducted. They were identified using the recommended threshold for the Hospital Anxiety and Depression Scale, the Fatigue Questionnaire, and a score of one or more on a numeric rating scale for pain. The SC was defined to include all the three variables, all other combinations were defined as no SC. Logistic regression analyses were conducted to examine the association between sociodemographic and clinical variables and the SC. Results Of the 834 survivors, 13% had the SC. Younger age (OR 2.3, 95% CI 1.3–4.1, p = 0.003), lymphedema (OR 1.9, 95% CI 1.1–3.2, p = 0.02), working part-time (OR 2.9, 95% CI 1.6–5.3, p p Conclusion Thirteen percent of the survivors experienced the SC. It appears that premenstrual women are at greater risk, than postmenopausal women. Having this SC might have an impact on the survivors’ ability to work.

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. The Palliative Radiotherapy and Inflammation Study (PRAIS) is funded by a non-restricted grant given by the Norwegian Cancer Society (NCS) to the European Palliative Care Research Centre (PRC). In addition, the study has financing for a PhD scholarship from the Liaison Committee for Education, Research and Innovation in Central Norway. The study sponsors and funders are not involved in data collection, analyses, interpretation or publication of data