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PurposeThe front-end phase plays an important role in achieving project success, and establishment of performance measurement systems considering project challenges or pitfalls is a way of keeping track of this phase. Early warning signs, a type of proactive performance indicators, may serve as means for improving decision-making and project processes aiming for short- and long-term project success. In this paper, the authors present findings from a study on early warning signs (EWS) in hospital projects' front-end. A preliminary systematisation of identified signs as a contribution to front-end improvement is provided.Design/methodology/approachThe paper is based on a mixed methods approach, using a sequential, exploratory research design comprising document studies, interviews and a survey.FindingsThe authors identified 62 challenges for hospital projects' front-end performance and further established four categories of EWS as follows: (1) structure and tools, (2) context and frame factors, (3) management and (4) relational factors and properties. This mirrors the presence of hard and soft issues from previous studies. There is need for clarifying terminology and raising consciousness on EWS. Processual approaches to identify EWS are considered more useful than subsequent established indicators.Originality/valueThe findings from this paper provide insight into EWS in hospital projects' front-end phase. This adds to the general understanding of EWS and contributes to more knowledge on the front-end phase in general.

Introduction To improve quality across levels of care, we developed a standardized care pathway (SCP) integrating palliative and oncology services for hospitalized and home-dwelling palliative cancer patients in a rural region. Methods A multifaceted implementation strategy was directed towards a combination of target groups. The implementation was conducted on a system level, and implementation-related activities were registered prospectively. Adult patients with advanced cancer treated with non-curative intent were included and interviewed. Healthcare leaders (HCLs) and healthcare professionals (HCPs) involved in the development of the SCP or exposed to the implementation strategy were interviewed. In addition, HCLs and HCPs exposed to the implementation strategy answered standardized questionnaires. Hospital admissions were registered prospectively. Results To assess the use of the SCP, 129 cancer patients were included. Fifteen patients were interviewed about their experiences with the patient-held record (PHR). Sixty interviews were performed among 1320 HCPs exposed to the implementation strategy. Two hundred and eighty-seven HCPs reported on their training in and use of the SCP. Despite organizational cultural differences, developing an SCP integrating palliative and oncology services across levels of care was feasible. Both HCLs and HCPs reported improved quality of care in the wake of the implementation process. Two and a half years after the implementation was launched, 28% of the HCPs used the SCP and 41% had received training in its use. Patients reported limited use and benefit of the PHR. Conclusion An SCP may be a usable tool for integrating palliative and oncology services across care levels in a rural region. An extensive implementation process resulted in improvements of process outcomes, yet still limited use of the SCP in clinical practice. HCLs and HCPs reported improved quality of cancer care following the implementation process. Future research should address mandatory elements for usefulness and successful implementation of SCPs for palliative cancer patients. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-021-00176-y., Plain language summary When a patient has incurable cancer, it is beneficial to introduce palliative care early in the disease trajectory along with anti-cancer treatment. A standardized care pathway is a method to improve quality and reduce variation in healthcare. It can promote integrated healthcare services in palliative care, e.g. by specifying action points when the patient’s situation is changing. In this study, a standardized care pathway for cancer patients with palliative care needs was developed in a rural region of Norway. The pathway focused on patients’ needs and symptoms and on smooth transition between levels of care. An educational program and an information strategy were developed to ensure implementation. To evaluate the implementation, all activity regarding the implementation process was registered. Cancer patients and healthcare professionals were interviewed and answered questionnaires. One thousand three hundred and twenty healthcare professionals were exposed to the implementation strategy. One hundred and twenty-nine cancer patients were followed up according to the standardized care pathway. Despite different perspectives of care, it was feasible to develop a standardized care pathway for palliative cancer patients across care settings. A paper-based patient-held record was only found to be useful by a limited number of patients. An extensive implementation process was completed and resulted in improvements regarding healthcare professionals’ experience with the quality of cancer care in the region, but limited use of the care pathway in clinical practice. Further research should identify the most important elements for usefulness and successful implementation of the care pathway. Supplementary Information The online version contains supplementary material available at 10.1007/s40487-021-00176-y.

This clinical study aimed to evaluate lung cancer patients' ability to perform deep inspiration breath-hold (DIBH) during CT simulation and throughout the treatment course of stereotactic body radiation therapy (SBRT). In addition, target sizes, organ at risk (OAR) sizes, and doses to the respective volumes in filter-free volumetric-modulated arc therapy plans performed under free-breathing (FB) and DIBH conditions were evaluated. Twenty-one patients with peripheral lesions were included, of which 13 were eligible for SBRT. All patients underwent training for breath-hold during CT, and if they complied with the requirements, two CT scans were obtained: CT scan in DIBH and a four-dimensional CT scan in FB. The treatment plans in FB and DIBH were generated, and the dose parameters and volume sizes were compared. The endpoints for evaluation were patient compliance, target dose coverage, and doses to the OARs. This clinical study showed high patient DIBH compliance during both CT simulation and treatment for patients with lung cancer. A significant reduction in target volumes was achieved with SBRT in DIBH, in addition to significantly decreased doses to the heart, chest wall, and lungs. DIBH in SBRT of lung lesions is feasible, and a routine to manage intra-fractional deviation should be established upon implementation.

Few qualitative studies of barriers and facilitators when implementing electronic patient-reported outcome measure (ePROM) in municipal cancer care exist within the large body of symptom assessment research. Such data, gathered from healthcare professionals' (HCPs) perspective, are central to the development and design of sustainable interventions aiming for a systematic and patient-centered symptom assessment to patients with cancer.The aim of this study was to identify and explore barriers and facilitators, as described by HCPs, in the implementation of the ePROM application "Eir" at a municipal cancer care unit in Norway.The study applies a qualitative method, conducting an inductive data inquiry of semistructured individual interviews and focus groups with 14 Norwegian HCPs. Analysis was inspired by thematic analysis as described by Braun and Clarke.The analysis revealed 3 main themes affecting the implementation of ePROM in municipal cancer care: "achieving patient-centered care," "crucial management and training," and "technological barriers."The results from this study suggest that HCPs' motivation plays a significant role when implementing ePROM. Motivation of HCPs was strongly influenced by whether the application added value to previously used symptom assessment. Hands-on management and a multiprofessional approach enabled the implementation by facilitating adaptations, training, and resources.The findings show that adapting the implementation of ePROMs to patient population could be of major importance. Early integration of ePROMs in cancer care could facilitate use throughout the disease trajectory.

Background Curative radiation therapy (RT) constitutes a cornerstone in prostate cancer (PC) treatment. We present long-term follow-up estimates for second cancer (SC) risk and overall survival (OS) in patients randomized to hormone therapy (ET) alone or combined with 70 Gy prostatic RT in the Scandinavian Prostate Cancer Group-7 (SPCG-7) study. We explored the effect of salvage RT (≥60 Gy to the ET group) and reported causes of death. Methods and Materials The SPCG-7 study (1996-2002) was a randomized controlled trial that included 875 men with locally advanced nonmetastatic PC. In this analysis, including data from the Norwegian and Swedish Cancer and Cause of Death registries for 651 Norwegian and 209 Swedish study patients, we estimated hazard ratios (HRs) for SC and death, and cumulative incidences of SC. Results Median follow-up of the 860 (431 ET and 429) ET + RT patients was 12.2 years for SC risk analysis and 12.6 years for the OS analysis. Eighty-three of the Norwegian ET patients received salvage RT, and median time to salvage RT was 5.9 years. We found 125 and 168 SCs in the ET and ET + RT patients, respectively. With ET alone as reference, ET + RT patients had an HR of 1.19 (95% confidence interval [CI], 0.92-1.54) for all SCs and 2.54 (95% CI, 1.14-5.69) for urinary bladder cancer (UBC). The total number of UBC was 31 (23 in ET + RT; 8 in ET), and the vast majority (85%) were superficial. The HR for SC in salvage RT patients was 0.48 (95% CI, 0.24-0.94). Median OS was 12.8 (95% CI, 11.8-13.8) and 15.3 (95%, CI 14.3-16.4) years in the ET and ET + RT groups, respectively. Compared with ET alone, the risk of death was reduced in ET + RT patients (HR, 0.73; 95% CI, 0.62-0.86) and in ET patients receiving salvage RT (HR, 0.44; 95% CI, 0.30-0.65). Conclusions Although the risk of UBC was increased in PC patients who received RT in addition to ET, this disadvantage is outweighed by the OS benefit of RT confirmed in our study. The risk of SC, and especially UBC, should be discussed with patients and be reflected in follow-up programs.

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.

Objective: Physical rehabilitation programs hold the potential to mitigate deterioration in health-related quality of life (HRQoL) in patients with head and neck cancer. The objective was to assess development in relevant domains of HRQoL following a physical exercise and nutrition intervention administrated during or after treatment. Methods: In a pilot study, 41 patients were randomized to resistance training and oral nutritional supplements during (EN-DUR, n = 20) or after (EN-AF, n = 21) radiotherapy. Global health status/QoL (GHS) and physical functioning (PF) were measured by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire at baseline, week 6, and week 14. Differences between the groups were assessed by analysis of covariance. A difference of ≥10 points in GHS and PF was interpreted as clinically relevant. Results: No statistically significant differences were detected between the groups; however, clinically relevant changes and differences in GHS and PF were observed. From baseline to week 6, GHS decreased 9 points in the EN-DUR group and 23 points in the EN-AF group and PF decreased 13 points and 21 points, respectively. From week 6 to week 14, GHS increased 14 points in the EN-DUR group and 26 points EN-AF group and PF did not change (0 points) in the EN-DUR group and increased 16 points in the EN-AF group. Conclusion: The findings from the present pilot study are promising and indicate that a physical rehabilitation program may have a positive impact on HRQoL during treatment and enhance recovery after treatment. A definitive randomized trial is warranted. Level of evidence: 1b-Individual randomized controlled trial. © 2020 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals, Inc. on behalf of The Triological Society. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

Introduction Early access to cancer palliative care is recommended. Descriptions of structures and processes of outpatient palliative care clinics operated within smaller hospitals are scarce. This paper presents the development and operation of a fully integrated cancer and palliative care outpatient clinic at a local hospital in a rural region of Mid-Norway offering palliative care concurrent with cancer treatment. A standardized care pathway was applied. Methods Palliative care is in Norway part of the public healthcare system. Official recommendations recent years point out action points to improve delivery of palliative care. An integrated cancer and palliative care outpatient clinic at a local hospital and an innovative care delivery model was developed and operated in this setting. Patients were recruited for a descriptive study of the patient population. Clinical data were collected by clinical staff and 13 symptom intensities were reported by the patients. Results Cancer and palliative care were provided by one team of healthcare professionals trained in both fields. There was a close collaboration with the other departments at the hospital, with its affiliated tertiary hospital, and with community health and care services to provide timely referral, enhanced continuity, and improved coordination of care. Eighty-eight patients were included. Mean age was 65.6 years, the most common cancer diagnoses were digestive organs (22.7%), male genital organs (20.5%) or breast (25.0%), 75.0% had metastatic or locally advanced cancer, 59.1% were treated with non-curative intention and 93.1% had Karnofsky Performance Status ≥ 80%. Median scores of individual symptoms ranged from 0 to 3 (numerical rating scale, 0–10) and 61.0% reported at least one clinically significant symptom rating (≥ 4). Conclusion This delivery model of integrated outpatient cancer and palliative care is particularly relevant in rural regions allowing cancer patients access to palliative care earlier in the disease trajectory and closer to home, Plain Language Summary Palliative care is an important part of cancer care which aims at improving cancer patients’ symptom burden and quality of life and support their carers. Palliative care has traditionally been separated from cancer care. During the last decade, one has become aware of the benefits of introducing palliative care early and concurrent with cancer treatment. Most cancer patients are nowadays treated as outpatients. Availability of palliative care as a routine part of outpatient cancer clinics is therefore important. Most of the described models of early palliative care in cancer care are within large tertiary hospitals. Here it is described how early palliative care was delivered to cancer patients in an outpatient clinic in a smaller hospital in a rural region of Mid-Norway. In this integrated cancer and palliative care outpatient clinic, cancer and palliative care were provided by one team of healthcare professionals trained in both fields. The integrated outpatient clinic collaborated closely with the other hospital departments and with community health and care services. This was needed to be able to offer palliative care to all cancer patients in need of it, and closer to their home. Many of the patients attending the integrated outpatient clinic could not be cured for their cancer. They did not have many symptoms of their cancer, and they had a high functional status. This demonstrated that the integrated outpatient clinic in this local hospital was a relevant place to offer palliative care early and concurrent with cancer treatment before symptoms became severe.

Background Erectile dysfunction is a common side effect of prostate cancer (PC) therapy. In this randomized study (The RIC-study) we used patient reported outcomes to evaluate sexual function 18 months after combined endocrine therapy and radical radiotherapy (RT) given with either wide or tight planning target volume (PTV) margins. We also analyzed the impact of radiation dose to penile bulb on sexual function. Methods The RIC-study included 257 men with intermediate and high-risk PC. All patients received 6 months of total androgen blockage started 3 months prior to randomization. In high-risk patients, an oral anti-androgen (Bicalutamide) was administered for an additional 2.5 years. Patients were randomized to receive 78 Gy in 39 fractions guided either by weekly offline orthogonal portal imaging or by daily online cone beam computed tomography image-guided RT. Sexual function was evaluated at 18 months after start of RT using the Questionnaire Umeå Fransson Widmark 1994. Ability to have an erection was assessed on an 11-point scale numerical rating scale (0 = no and 10 = very much) as the primary outcome. In addition, the association between penile bulb (PB) radiation dose and erectile function was analyzed. Findings Of 250 evaluable patients, 228 (mean age 71.8 years) returned the questionnaires. The patients reported a high degree of sexual related problems with mean scores to the primary outcome question (221 respondents) of 7.44 and 7.39 in the 2D weekly IGRT-arm and 3D daily IGRT-arm (p = 0.93) respectively. For four additional questions (scale 0–10) regarding sexual function resulted in mean scores >6.5 with no difference between study arms. The mean dose to PB was substantially larger in the 2D weekly IGRT-arm vs the 3D daily IGRT-arm (mean 59.8 Gy vs mean 35.1 Gy). We found no effect of mean PB-dose on the primary outcome adjusted for study-site, risk-group and age. When adjusting for serum-testosterone level at 18 months in addition, the effect of mean PB-dose remained insignificant. Interpretation IGRT protocol or PB dose had no effect on ED 18 months after RT in this study population. The low potency rates can partly be explained by the prolonged use of anti-androgen in high risk patients. Longer follow-up is needed to confirm the results from the RIC-study. © 2018 The Authors. Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).

Purpose Prostate cancer (PC) patients who undergo antiandrogen monotherapy are offered prophylactic radiation therapy (PRT) to the breast buds to avoid gynecomastia. The aim of the present study was to evaluate whether the risk of breast cancer (BC) in men with PC as their first cancer diagnosis was influenced by PRT. Methods and Materials From the Norwegian Cancer Registry, we collected data from all patients with PC as their first cancer diagnosis from 1997 to 2014. We registered all RT given to the patients in the same period and the occurrence of BC diagnosed ≥3 months after the PC diagnosis. The histopathologic diagnoses of all BC cases were collected. Subdistribution hazard ratios for the risk of BC in the PRT and non-PRT groups were estimated. A standardized incidence ratio for BC was calculated by comparing our cohort to the standard male population. Results We analyzed 59,169 patients with PC, of whom 7864 (13.3%) had received PRT. The median follow-up time was 4 years. Of the 12 men with a diagnosis of BC, 3 had received PRT, and 2 of the 3 were phyllodes tumors. The risk of BC was not significantly different statistically for the patients given PRT compared with the non-PRT group (subdistribution hazard ratio 1.62, 95% confidence interval 0.41-5.62, adjusted for age and time of diagnosis). The standardized incidence ratio was 0.996 (95% confidence interval 0.57-1.75). Conclusions In this registry-based study, we did not find an increased risk of BC in PC patients who received PRT. The number of BC cases in our study was low, and the risk of secondary BC after PRT seems to be negligible. The incidence of BC could, however, increase with additional follow-up. Also, 2 patients who had received PRT developed a malignant phyllodes tumor, an extremely rare type of BC associated with gynecomastia. © 2018. This is the authors’ accepted and refereed manuscript to the article. Locked until 5 February 2019 due to copyright restrictions. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/

Background Novel cancer drugs are subject to strict scientific evaluation of safety and efficacy and usually undergo a cost effectiveness analysis before approval for use in clinical practice. For new techniques in radiotherapy (RT) such as image-guided radiotherapy (IGRT), this is often not the case. We performed a randomized controlled trial to compare daily cone beam computer tomography (CBCT) IGRT with reduced planning target volume (PTV) margins vs weekly orthogonal portal imaging with conventional PTV margins. The primary aim of the study was to investigate the effect of two different image guidance techniques on patient reported outcome (PRO) using early side effects as proxy outcome of late rectal side effects in patients receiving curative RT for prostate cancer. Methods This open label, phase 3 trial conducted at two RT centers in Norway enrolled men aged 18 years or older with previously untreated histologically proven intermediate or high-risk adenocarcinoma of the prostate. Patients eligible for radical RT received it after 3 months of total androgen blockage and were randomly assigned to 78 Gy in 39 fractions guided either by weekly offline orthogonal portal imaging (15 mm margins to PTV) or by daily online CBCT IGRT (7 mm margins to PTV). Based on previous results indicating that acute rectal side effects are a valid proxy outcome for late rectal side effects, the primary outcome was acute rectal toxicity at end of RT as evaluated by rectal bother scale (five of the items from PRO’s QUFW94). The RIC-trial is registered with ClinicalTrials.gov, number NCT01550237. Findings Between October 2012 and June 2015, 257 patients were randomly assigned to weekly offline portal imaging (n = 129) or daily online CBCT IGRT (n = 128). Out of 250 evaluable patients, 96% completed PROs at baseline and 97% at end of RT. Baseline analyses demonstrated balance between groups for baseline characteristics as well as for PROs. In general, patients reported a small degree of side effects at end of RT, and there was no difference between groups for primary outcome (rectal bother scale of QUFW94 1.871 vs 1.884, p = 0.804). In addition, there were no significant differences between groups for any other gastrointestinal or urinary symptom as reported by QUFW94. Health related quality of life analyses (EORTC QLQ 30) demonstrated no differences between groups. Interpretation In radical RT for prostate cancer, daily CBCT IGRT with reduced PTV margins demonstrated no advantage with respect to patient reported side effects at end of RT as compared to weekly orthogonal offline portal imaging with standard PTV margins. © 2018. This is the authors’ accepted and refereed manuscript to the article. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/

BACKGROUND Patients with head and neck cancer (HNC) experience involuntary weight loss that has a negative impact on physical function, morbidity, and survival. The objective of the current study was to evaluate the feasibility of an exercise and nutrition intervention during radiotherapy (RT) compared with after RT, and to examine preliminary effects on skeletal muscle mass. METHODS Patients with HNC were randomized to an exercise and nutrition intervention during RT (EN-DUR) or after RT (EN-AF). The EN-DUR intervention was conducted at a hospital and the EN-AF intervention took place at a rehabilitation center. The interventions consisted of progressive resistance training (PRT) and oral nutritional supplements (ONS). Feasibility outcomes were tracked weekly and muscle mass was measured by computed tomography scans before and after RT and at 2 months follow-up. RESULTS Of the 50 eligible patients, 41 (82%) agreed to participate. 90% of patients completed the EN-DUR intervention and the adherence to PRT and ONS was 81% and 57%, respectively. 52% of patients attended the EN-AF intervention and adherence to PRT and ONS was 94% and 76%, respectively. The EN-DUR demonstrated a trend toward mitigating loss of muscle mass during RT and the EN-AF demonstrated a similar trend after RT. No difference in muscle mass was detected between the groups from baseline to week 14. CONCLUSIONS An exercise and nutrition intervention is feasible for patients with HNC during RT, and the intervention is potentially effective in mitigating loss of muscle mass both during and after RT. Future trials should assess the feasibility and effects of extended interventions during and after treatment. Cancer 2017;123:4440-8. © 2017 American Cancer Society.

Intrafraction motion in breast cancer radiation therapy (BCRT) has not yet been thoroughly described in the literature. It has been observed that baseline drift occurs as part of the intrafraction motion. This study aims to measure baseline drift and its incidence in free-breathing BCRT patients using an in-house developed laser system for tracking the position of the sternum.Baseline drift was monitored in 20 right-sided breast cancer patients receiving free breathing 3D-conformal RT by using an in-house developed laser system which measures one-dimensional distance in the AP direction. A total of 357 patient respiratory traces from treatment sessions were logged and analysed. Baseline drift was compared to patient positioning error measured from in-field portal imaging.The mean overall baseline drift at end of treatment sessions was -1.3 mm for the patient population. Relatively small baseline drift was observed during the first fraction; however it was clearly detected already at the second fraction. Over 90% of the baseline drift occurs during the first 3 min of each treatment session. The baseline drift rate for the population was -0.5 ± 0.2 mm/min in the posterior direction the first minute after localization. Only 4% of the treatment sessions had a 5 mm or larger baseline drift at 5 min, all towards the posterior direction. Mean baseline drift in the posterior direction in free breathing BCRT was observed in 18 of 20 patients over all treatment sessions.This study shows that there is a substantial baseline drift in free breathing BCRT patients. No clear baseline drift was observed during the first treatment session; however, baseline drift was markedly present at the rest of the sessions. Intrafraction motion due to baseline drift should be accounted for in margin calculations.

Introduction: The aim of this registry-based cohort study was to estimate second cancer (SC) risk following radical prostate cancer (PC) treatment and evaluate if the risk was influenced by radiotherapy. Materials and methods: We collected data from the Cancer Registry of Norway on all patients with PC as first cancer diagnosis, from 1997 to 2014. Standardized incidence ratios (SIRs) for SC were calculated by comparing our cohort to the standard male population. Subdistribution hazard ratios were estimated in treatment groups, using patients treated with radical prostatectomy (RP) as reference. Results: We analyzed 24,592 radically treated PC patients. The median follow-up was 7.75 and 6.25 years in the external beam radiotherapy (EBRT) and RP-groups, respectively. SIR for SC was indifferent from the reference population in 24,592 radically treated patients, higher following EBRT, SIR 1.12 (1.07–1.17), and lower following RP, SIR 0.93 (0.87–0.99). EBRT treated patients had higher rectal and urinary bladder cancer incidences, SIR 1.38 (1.16–1.64) and 1.49 (1.31–1.69), respectively. The EBRT patients and the patients treated with radiation after RP (RT after RP) had 38 and 27% higher risk of any SC. We found higher risk of bladder cancer for all treatment groups as compared to RP patients. Only EBRT treated patients showed higher risk of rectal and lung cancer. Discussion/conclusions: In our study, we found that PC patients treated with EBRT had an increased incidence of SC compared to the general population. Patients treated with EBRT and RT after RP were found to have increased risk of SCs, using RP patients as reference. The risks of rectal and urinary bladder cancer in patients receiving EBRT were higher compared to both the general population and to patients treated with radical prostatectomy. The risk of SC should be taken into account when discussing treatment for patients and designing follow-up.

The introduction of modern image-guided radiotherapy (IGRT) has given new insight regarding organ motion in radiotherapy (RT), both in general and in treatment for prostate cancer (PC) [1]. IGRT with daily Cone-beam computed tomography (CBCT) is now considered as part of standard external beam radiotherapy (EBRT) in an increasingly number of cancer patients. Interfraction displacement of the prostate gland during RT is often observed in response to the variations in rectum and bladder filling, and can range from 0 to 20 mm [1], [2], [3], [4], [5], [6], [7]. Accordingly, rectal volume variation (RVV) during RT may increase the risk of biochemical and local failure [8], [9], [10], [11], [12], [13]. Moreover, the rectal volume (RV) receiving ≥ 60 Gy is associated with increased risk of grade ≥ 2 late rectal toxicity or rectal bleeding and can be a limiting factor for dose escalation [14], [15], [16], [17], [18], [19]. Some small sample-size studies have reported variable rectal dose distribution due to RVV during RT [2], [20], [21]. In order to minimize RVV, some authors advocate rectum emptying using an enema eventually combined with laxatives and dietary measures at the time of the initial planning computed tomography (CT) and during the treatment period, especially if daily IGRT is not applied [22], [23]. Consequently, studies on radiation dose distribution and variations in Organs at Risk during the total treatment period are essential to gain knowledge about the accuracy of dose delivery to the tumor and the surrounding normal tissue. The aim of this study was to answer the following research question: Are rectal volumes reduced or increased, and are rectal doses consequently reduced or increased during eight weeks of radical 3D conformal CBCT-IGRT in patients treated for PC? (C) 2019 The Authors. Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology.This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Background Stereotactic body radiotherapy (SBRT) has been introduced for small lung tumors due to excellent local control and few side effects, even though there are no comparative studies. SPACE (Stereotactic Precision And Conventional radiotherapy Evaluation) is the first randomized phase II trial comparing SBRT and conventional fractionated radiotherapy (3DCRT). Methods Patients with stage I medically inoperable NSCLC were randomized to receive SBRT to 66Gy in 3 fractions (one week) or 3DCRT to 70Gy (7weeks). Patients were followed to assess efficacy, toxicity and HRQL. Findings Between 2007 and 2011, 102 patients were randomized. Mean age 74 (57-86), 60% women, the vast majority (92%) had COPD or cardiovascular comorbidity. The SBRT arm included more patients with T2-tumors (p=0.02) and male gender (p=0.35). The median follow-up was 37months with a 1-, 2- and 3-year PFS of: SBRT: 76%, 53%, 42% and 3DCRT: 87%, 54% 42%, HR=0.85 (95% CI 0.52-1.36) with no difference between the groups and no difference in OS (HR=0.75, 95% CI 0.43-1.30). At the end of the study 70% of SBRT patients had not progressed compared to 59% (3DCRT, p=0.26). Toxicity was low with no grade 5 events. Pneumonitis of any grade was observed in 19% (SBRT) and 34% (3DCRT, p=0.26), and esophagitis in 8% and 30% respectively (p=0.006). HRQL was evaluated with the EORTC QLQ 30 and LC14 module and patients treated with 3DCRT experienced worse dyspnea (p=0.01), chest pain (p=0.02) and cough (>10 points difference). Interpretation There was no difference in PFS and OS between SBRT and conventionally treated patients despite an imbalance of prognostic factors. We observed a tendency of an improved disease control rate in the SBRT group and they experienced better HRQL and less toxicity. SBRT is convenient for patients and should be considered standard treatment for patients with inoperable stage I NSCLC.

Background Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy. Methods Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module’s scale structure was examined and validated using standard psychometric analysis techniques. Results Three items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3–0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities. Conclusion The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224. Electronic supplementary material The online version of this article (10.1186/s13014-018-1107-x) contains supplementary material, which is available to authorized users.

Purpose The aim of our study was to evaluate and compare the robustness of treatment plans produced using the volumetric modulated arc-therapy (VMAT) and the standard three-dimensional conformal radiotherapy (3DCRT) techniques by estimating perturbed doses induced by localization offsets for deep inspiration breath-hold (DIBH) in locally advanced breast cancer radiation therapy. Methods Twenty patients with left breast carcinoma requiring radiation therapy were analysed in this planning study. Robust VMAT plans regarding minimum CTV doses and standard 3DCRT plans were produced, and perturbed doses were calculated in accordance with localization values from the weekly offline imaging protocol. Offsets from 5 weeks were summed to a perturbed overall treatment plan. Dose criteria for evaluation were coverage and homogeneity of the target, as well as doses to organs at risk. Results VMAT plans resulted in significantly better target coverage compared to 3DCRT, as well as lowered doses to heart and left anterior descending artery, while the perturbed doses were less variable for VMAT than 3DCRT plans. Homogeneity was significantly improved in VMAT plans. The statistical analysis taking all organs into account found that VMAT plans were more robust than 3DCRT to localization offsets (p = .001). The overall mean setup-deviation for the DIBH-patients was less than 2 mm in all directions. Conclusions VMAT plans were more robust on average than conventional 3DCRT plans for DIBH when localization errors were taken into consideration. The combination of robust VMAT planning and DIBH generally improves the homogeneity and target doses. © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license

Patients with head and neck cancer (HNC) experience involuntary weight loss that has a negative impact on physical function, morbidity, and survival. The objective of the current study was to evaluate the feasibility of an exercise and nutrition intervention during radiotherapy (RT) compared with after RT, and to examine preliminary effects on skeletal muscle mass.Patients with HNC were randomized to an exercise and nutrition intervention during RT (EN-DUR) or after RT (EN-AF). The EN-DUR intervention was conducted at a hospital and the EN-AF intervention took place at a rehabilitation center. The interventions consisted of progressive resistance training (PRT) and oral nutritional supplements (ONS). Feasibility outcomes were tracked weekly and muscle mass was measured by computed tomography scans before and after RT and at 2 months follow-up.Of the 50 eligible patients, 41 (82%) agreed to participate. 90% of patients completed the EN-DUR intervention and the adherence to PRT and ONS was 81% and 57%, respectively. 52% of patients attended the EN-AF intervention and adherence to PRT and ONS was 94% and 76%, respectively. The EN-DUR demonstrated a trend toward mitigating loss of muscle mass during RT and the EN-AF demonstrated a similar trend after RT. No difference in muscle mass was detected between the groups from baseline to week 14.An exercise and nutrition intervention is feasible for patients with HNC during RT, and the intervention is potentially effective in mitigating loss of muscle mass both during and after RT. Future trials should assess the feasibility and effects of extended interventions during and after treatment. Cancer 2017;123:4440-8. © 2017 American Cancer Society.

Deep inspiration breath hold (DIBH) in left‐sided breast cancer radiotherapy is a technique to reduce cardiac and pulmonary doses while maintaining target coverage. This study aims at evaluating an in‐house developed DIBH system. Free‐breathing (FB) and DIBH plans were generated for 22 left‐sided localized breast cancer patients who had radiation therapy (RT) after breast‐conserving surgery. All patients were treated utilizing an in‐house laser distance measuring system. 50 Gy was prescribed, and parameters of interest were target coverage, left anterior descending coronary artery, (LAD) and heart doses. Portal images were acquired and the reproducibility and stability of DIBH treatment were compared to FB. The comparing result shows there is a significant reduction in all LAD and heart dose statistics for DIBH compared to FB plans without compromising the target coverage. The maximum LAD dose was reduced from 43.7 Gy to 29.0 Gy and the volume of the heart receiving >25 Gy was reduced from 3.3% to 1.0% using the in‐house system, both statistically significant. The in‐house system gave a reproducible and stable DIBH treatment where the systematic error ∑, and random error σ, were less than 2.2 mm in all directions, but were not significantly better than at FB. The system was well tolerated and all patients completed their treatment sessions with DIBH. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

16 Background: We estimated second cancer (SC) risk following radical prostate cancer (PC) treatment and evaluated if the risk was influenced by treatment. Methods: We analyzed data from the Cancer Registry of Norway on all patients with PC (first cancer diagnosis) from 1997-2014. Standardized incidence ratios (SIRs) for SC were calculated. Subdistribution hazard ratios (SHRs) were estimated in treatment groups (prostatectomy (RP) reference). Results: Median follow-up in 24155 radically treated patients was 6 and 4 years in the external beam radiotherapy (EBRT) and RP-groups, respectively. SC-incidence was indifferent from that of the reference population in 24155 radically treated patients, higher following EBRT, SIR 1.06(1.01-1.12), and lower following RP, SIR 0.91(0.84-0.98). EBRT-patients had higher rectal and urinary bladder cancer incidences. Compared to RP, the EBRT-patients had a 38 % higher risk of any SC. Respective figures for rectal, urinary bladder and lung cancer: 72, 38, and 113%. Conclusions: EBRT-patients had a slightly higher SC-incidence than the general population. The rectal and urinary bladder cancer risk should be taken into account in follow-up after EBRT.[Table: see text]

Numerous randomised clinical trials have shown that the efficacy of single fraction radiotherapy for metastatic bone pain corresponds to that of multiple fractions of radiotherapy for the majority of patients. It is not clear to which extent single fraction radiotherapy has been implemented into clinical practice.A Norwegian national registry-based study was conducted, including all radiotherapy schedules of 8 Gy × 1 and 3 Gy × 10 delivered to bone metastases in 1997-2007. Binomial regression analyses were used to study whether treatment centre, primary diagnosis, anatomical region irradiated, age, sex, and travel distance, were associated with the choice of fractionation.A total of 14 380 radiotherapy episodes were identified. During the period 31% of the treatments were delivered as 8 Gy × 1. The proportion of single fraction treatments increased from 16% in 1997 to 41% in 2007. There were substantial differences in the proportion of single fraction treatments between the treatment centres (range 25-54%). These differences persisted after adjustment for sex, age, primary diagnosis, anatomical region, and travel distance.The study demonstrates an underutilisation of single fraction treatment for bone metastases in Norway during the study period.

Malignant spinal cord compression (MSCC) in patients with short life expectancy is most frequently treated with radiotherapy and/or corticosteroids. Hypofractionation has been proven to be efficient in metastatic bone pain, but the level of evidence for hypofractionation in MSCC is limited. Searches were performed in PubMed, Embase and the Cochrane Library for all relevant articles. Two randomised controlled trials (RCTs) were identified. The first RCT compared hypofractionation (8 gray (Gy)×2) with a more fractionated regimen. No differences in symptom control, duration of response or survival were detected. The second RCT compared 8 Gy×2 with 8 Gy×1. No significant differences in symptom control, duration of response or survival were detected. Five prospective non-randomised studies identified no differences in post-treatment motor function. Of 17 identified retrospective studies the largest included 1304 patients, treated with five different regimens ranging from 8 Gy×1 to 2 Gy×20, and found similar post-treatment ambulatory status. A Cochrane review based on the first published RCT concluded that short courses of radiotherapy appear to be justified in patients with a poor prognosis.

BACKGROUND AND PURPOSE: Radiation proctitis is a side effect which can occur after pelvic radiation therapy. Currently available questionnaires do not comprehensively assess the range of problems, nor impact on quality of life associated with proctitis. This article reports on the cultural testing phase of an EORTC module (QLQ-PRT21) developed to assess radiation proctitis specific issues and designed to be used in conjunction with the EORTC core quality of life questionnaire (QLQ-C30). METHODS: The previously developed 21-item module, pre-tested in Australia, was translated into Norwegian, German, French and Italian. Patients completed the EORTC QLQ-C30 and module questionnaires towards the end of their radical pelvic radiation treatment to target acute side effects. Patients experiencing chronic proctitis were also surveyed. Patients also participated in structured interviews to determine issues of comprehensibility, coverage and relevance. Results were compared with Australian data. RESULTS: Questionnaires were completed by 64 European patients. The module was found to be relevant and culturally acceptable to participants. Feedback has led to minor translation modifications and the inclusion of two additional questions. CONCLUSION: This module is ready for Phase IV testing which will consist of large scale field testing with the aim to perform psychometric analysis and finalize a module that will be suitable in the assessment of radiation induced proctitis.

Purpose To investigate long-term changes in the rectal mucosa after curative external beam radiation therapy in the treatment of prostate cancer. Methods and Materials In the Scandinavian Prostate Cancer Group 7 trial, 880 men with locally advanced prostate cancer were randomized to hormonal therapy alone versus hormonal therapy plus radiation therapy to 70 Gy. A subcohort from this trial being randomized at our center (n=178) was invited to a study on late anorectal side effects during 2003-2005, approximately 5 years after treatment, including measuring health-reported quality of life and physician-assessed toxicity score by the Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group score. Sixty-seven patients had a rectal mucosa biopsy. Sixty-four biopsies were included in the final analysis, of which 33 patients were randomized to hormonal treatment and 31 to hormonal treatment plus radiation therapy. The presence of fibrosis, number of capillaries, and lymphocyte infiltration was then evaluated by light microscopy. Results The group receiving radiation therapy had significantly higher LENT/SOMA and function/bother scale scores than the group that only received hormonal treatment, but there was no significant difference in the presence of fibrosis, ectasia, number of capillaries in the lamina propria, or lymphocyte infiltration between the groups. Conclusion Radiation therapy to 70 Gy to the prostate does not induce long-term microscopic mucosal changes in the rectum 5 years after treatment. This is in contrast to the general assumption that structural changes, including fibrosis, seen after radiation therapy include the mucosa. We speculate that the main late effects of radiation therapy on the structure of the rectum are located in the deeper layers of the rectal wall than the mucosa.

Background and purpose To investigate whether single-fraction radiotherapy is equal to multiple fractions in the treatment of painful metastases. Patients and methods The study planned to recruit 1000 patients with painful bone metastases from four Norwegian and six Swedish hospitals. Patients were randomized to single-fraction (8 Gy×1) or multiple-fraction (3 Gy×10) radiotherapy. The primary endpoint of the study was pain relief, with fatigue and global quality of life as the secondary endpoints. Results The data monitoring committee recommended closure of the study after 376 patients had been recruited because interim analyses indicated that, as in two other recently published trials, the treatment groups had similar outcomes. Both groups experienced similar pain relief within the first 4 months, and this was maintained throughout the 28-week follow-up. No differences were found for fatigue and global quality of life. Survival was similar in both groups, with median survival of 8–9 months. Conclusions Single-fraction 8 Gy and multiple-fraction radiotherapy provide similar pain benefit. These results, confirming those of other studies, indicate that single-fraction 8 Gy should be standard management policy for these patients.

Background. In SBRT of lung tumours no established relationship between dose-volume parameters and the incidence of lung toxicity is found. The aim of this study is to compare the LQ model and the universal survival curve (USC) to calculate biologically equivalent doses in SBRT to see if this will improve knowledge on this relationship. Material and methods. Toxicity data on radiation pneumonitis grade 2 or more (RP2+) from 57 patients were used, 10.5% were diagnosed with RP2+. The lung DVHs were corrected for fractionation (LQ and USC) and analysed with the Lyman- Kutcher-Burman (LKB) model. In the LQ-correction α/β = 3 Gy was used and the USC parameters used were: α/β = 3 Gy, D(0) = 1.0 Gy, [Formula: see text] = 10, α = 0.206 Gy(-1) and d(T) = 5.8 Gy. In order to understand the relative contribution of different dose levels to the calculated NTCP the concept of fractional NTCP was used. This might give an insight to the questions of whether "high doses to small volumes" or "low doses to large volumes" are most important for lung toxicity. Results and Discussion. NTCP analysis with the LKB-model using parameters m = 0.4, D(50) = 30 Gy resulted for the volume dependence parameter (n) with LQ correction n = 0.87 and with USC correction n = 0.71. Using parameters m = 0.3, D(50) = 20 Gy n = 0.93 with LQ correction and n = 0.83 with USC correction. In SBRT of lung tumours, NTCP modelling of lung toxicity comparing models (LQ,USC) for fractionation correction, shows that low dose contribute less and high dose more to the NTCP when using the USC-model. Comparing NTCP modelling of SBRT data and data from breast cancer, lung cancer and whole lung irradiation implies that the response of the lung is treatment specific. More data are however needed in order to have a more reliable modelling.

Purpose The impact of stereotactic body radiotherapy (SBRT) on 3-year progression-free survival of medically inoperable patients with stage I non–small-cell lung cancer (NSCLC) was analyzed in a prospective phase II study. Patients and Methods Fifty-seven patients with T1NOMO (70%) and T2N0M0 (30%) were included between August 2003 and September 2005 at seven different centers in Sweden, Norway, and Denmark and observed up to 36 months. SBRT was delivered with 15 Gy times three at the 67% isodose of the planning target volume. Results Progression-free survival at 3 years was 52%. Overall- and cancer-specific survival at 1, 2, and 3 years was 86%, 65%, 60%, and 93%, 88%, 88%, respectively. There was no statistically significant difference in survival between patients with T1 or T2 tumors. At a median follow-up of 35 months (range, 4 to 47 months), 27 patients (47%) were deceased, seven as a result of lung cancer and 20 as a result of concurrent disease. Kaplan-Meier estimated local control at 3 years was 92%. Local relapse was observed in four patients (7%). Regional relapse was observed in three patients (5%). Nine patients (16%) developed distant metastases. The estimated risk of all failure (local, regional, or distant metastases) was increased in patients with T2 (41%) compared with those with T1 (18%) tumors (P = .027). Conclusion With a 3-year local tumor control rate higher than 90% with limited toxicity, SBRT emerges as state-of-the-art treatment for medically inoperable stage I NSCLC and may even challenge surgery in operable instances.

Background and purpose The aim of this study was to compare the need for re-irradiation, rates of pathological fractures, and spinal cord compressions in patients randomised to single-fraction radiotherapy (8Gy×1) or multiple-fraction therapy (3Gy×10) and with a long-term follow-up. The underlying hypothesis was that single-fraction and multiple-fraction regimens are equally effective. Material and methods The present study reports on the Norwegian sub sample of an international large prospective-randomised multicentre study. One hundred and eighty patients with painful skeletal metastases in four Norwegian hospitals were randomised to receive single-fraction (8Gy×1) or multiple-fraction (3Gy×10) radiotherapy. Results Patients in the single-fraction arm received significantly more re-irradiations as compared to the multiple-fraction arm (27% versus 9%, p =0.002). There were no significant differences in the rate of pathological fractures (5% versus 5%, p =1.00) or spinal cord compressions (1% versus 4%, p =0.37) between the two treatment groups. Conclusion The present study indicates no difference between radiotherapy with 8Gy×1 and 3Gy×10 for the majority of patients with painful bone metastases, also in a long-term perspective. Importantly, the patients in this study were followed up until death, and the trial showed no disadvantage for 8Gy×1 compared to 3Gy×10. Despite the fact that single-fraction treatment will imply an approximately 2.5-fold greater need for re-irradiation, single-fraction treatment is considered more convenient for the patients and more cost-effective for the radiotherapy departments.

Several treatment options are available for patients with prostate cancer. Applicable and valid self-assessment instruments for assessing health-related quality of life (HRQOL) are of paramount importance. The aim of this study was to explore the validity and responsiveness of the intestinal part of the prostate cancer-specific questionnaire QUFW94.The content of the intestinal part of QUFW94 was examined by evaluation of experienced clinicians and reviewing the literature. The psychometric properties and responsiveness were assessed by analyzing HRQOL data from the randomized study Scandinavian Prostate Cancer Group 7 (SPCG)/Swedish Association for Urological Oncology 3 (SFUO). Subscales were constructed by means of exploratory factor analyses. Internal consistency was assessed by Cronbach's alpha. Responsiveness was investigated by comparing baseline scores with the 4-year posttreatment follow-up.The content validity was found acceptable, but some amendments were proposed. The factor analyses revealed two symptom scales. The first scale comprised five items regarding general stool problems, frequency, incontinence, need to plan toilet visits, and daily activity. Cronbach's alpha at 0.83 indicated acceptable homogeneity. The second scale was less consistent with a Cronbach's alpha at 0.55. The overall responsiveness was found to be very satisfactory.Two scales were identified in the bowel dimension of the QUFW94; the first one had good internal consistency. The responsiveness was excellent, and some modifications are suggested to strengthen the content validity.

e17515 Background: The number of beds in our ward was reduced from 68 in 2008-9 (A) to 36 in 2012-13 (B). The aim was to increase our capacity by treating more patients on an outpatient basis. To p...

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