Publications
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Festvåg, Line Elida; Eilertsen, Grethe; Sverre, Beate Lie & Paulsen, Ørnulf
(2026).
Feasibility and acceptability of including advance care planning in a home-based palliative-care coordination meeting: a longitudinal ethnographic study of the experiences of older patients, their relatives and healthcare professionals | BMC Palliative Care | Springer Nature Link.
BMC Palliative Care.
doi:
10.1186/s12904-026-02383-8.
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Advance care planning provides a structured approach to conversations about values and preferences but is uncommon in clinical practice. We implemented advance care planning as routine at the initiation of an individually tailored palliative care pathway in Norway. An advance care planning conversation formed part of the initial care coordination meeting when palliative care was introduced to older patients with advanced cancer. Healthcare professionals met with the patient and their relatives at home. This study aimed to assess the feasibility and acceptability of including advance care planning with older patients in a home-based palliative-care coordination meeting. We conducted a longitudinal ethnographic study utilizing ethnographic interviews with patients and their relatives within 1 week and 4 weeks after the initial meeting, and with healthcare professionals immediately before and after this meeting. Data were analysed using content analysis. All patients perceived the advance care planning conversation as useful. Proper preparation and information were prerequisites for successful outcomes. The presence of relatives, the home-based setting and healthcare professionals’ communication skills provided a comfortable atmosphere. Open discussions about sensitive topics were enabled, and the dialogue continued to evolve within the families after the conversation. However, the patients and their relatives perceived the follow-up and documentation as insufficient. Embedding advance care planning in a home-based palliative-care coordination meeting may offer a feasible model of its implementation for older patients with advanced cancer. The conversation was well accepted, but preparation and systematic follow-up were crucial for ensuring high quality.
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Guldhav, Kristin Vassbotn; Mcaleavey, Andrew Athan; Aass, Nina Kathrine; Andersen, Sigve; Christensen, Bente Mirjam & Dajani, Olav
[Show all 19 contributors for this article]
(2026).
Caregiver satisfaction with early integrated palliative care in oncology: secondary outcomes from the PALLiON cluster-RCT.
Frontiers in Oncology.
16,
p. 1–13.
doi:
10.3389/fonc.2026.1787814.
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Introduction
Palliative care is often introduced late in the disease trajectory. Earlier access to palliative care has been reported to benefit patient outcomes, but few studies have explored its impact on caregivers. PALLiON (PALLiative care Integrated in ONcology) was a cluster-randomized controlled trial designed to integrate systematic palliative care earlier in oncology settings. The aim of this follow-up study was to assess whether the intervention influenced caregivers’ satisfaction with care in the intervention group compared to the standard care group, and to explore whether patients’ quality of life (QoL) at inclusion influenced caregivers’ satisfaction with care over time.
Methods
The trial was conducted across 12 Norwegian hospitals. The intervention included a physician education program, a patient-centered care pathway, and systematic symptom assessment. Adult patients with advanced cancer and their caregivers were recruited. Caregivers’ satisfaction with care was assessed longitudinally using the FAMCARE-20 scale, while patients’ QoL was measured with the EORTC QLQ-C15-PAL questionnaire. Linear mixed-effects regression models were used to examine the intervention’s effects, and partial least squares regression to examine associations between the intervention and responses to each FAMCARE-20 item.
Results
A total of 432 caregivers of 660 patients participated between 2017 and 2021. The average caregiver age was 61.8 years (SD = 13.2), and 71% were spouses or partners. The intervention had no significant effect on caregivers’ overall satisfaction with care ( B = -0.070, 95% CI [-0.23, 0.082], β = 0.02, p = 0.35), and the groups did not significantly differ in slope of satisfaction with care over the first 6 months ( B = 0.040, 95% CI = [0.003, 0.08], β = 0.07, p = 0.07). Lower patient QoL at baseline was significantly associated with greater increases in caregiver satisfaction over time in both groups ( B = 0.001, 95% CI [0.0001, 0.003], β = 0.06, p = 0.03).
Conclusions
Caregivers’ satisfaction with care did not differ between the intervention and control groups. Satisfaction seemed to be more affected by patients’ baseline QoL rather than early palliative care. Thus, a systematic, person-centered approach rooted in needs may be more beneficial than a purely time-based palliative care model.
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Hagen, Katarina Margareta Rønning; McWilliams, Kerry; Bowden, Joanna; Harvie, Karen; Paulsen, Ørnulf & Fallon, Marie
(2026).
PaSo paracetamol with strong opioids trial: paracetamol versus placebo in conjunction with strong opioids for cancer pain—a pilot randomised placebo-controlled withdrawal trial.
BMJ Supportive & Palliative Care.
ISSN 2045-435X.
doi:
10.1136/spcare-2026-006267.
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Objectives: Clinical guidelines, including the WHO analgesic ladder, advocate paracetamol in conjunction with strong opioids for moderate to severe cancer pain despite a lack of evidence for its efficacy in this setting. This pilot study aimed to evaluate the feasibility of a larger randomised controlled trial (RCT) with the aim of establishing whether paracetamol combined with strong opioids provides superior analgesia for cancer-related pain over strong opioids alone.
Methods: Adult patients with incurable cancer taking regular paracetamol and strong opioids with an average pain score 2–8 on a Numeric Rating Scale (NRS 0–10) in the past 24 hours were randomised to receive either paracetamol or placebo for 13 days, with assessments at day 7 and 14. Outcomes were recruitment, retention, appropriateness of study design, patient acceptability and early signals of pain outcome.
Results: Thirty-four participants were recruited and 28 randomised at 12 months. After 7 months, the intervention phase was reduced to 7 days to improve recruitment and mitigate attrition. Retention was high but the clinical team assessed 7 days in the study as adequate and less burdensome for the patients. Average pain (NRS) on day 7 (change from baseline) was similar in the placebo group (−0.27) versus the paracetamol group (−0.46). Groups difference: −0.19, 95% CI −1.1 to 0.7, ( p =0.67). Patient recruitment was slow. Due to this, the study did not progress to a definitive RCT.
Conclusion: This pilot study demonstrates feasibility of the withdrawal design but signalled the need for a different recruitment strategy and a shorter study. Notably, there were no adverse pain outcomes, as NRS scores and opioid requirements didn’t increase. Trial registration number NCT02706769 .
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Lundereng, Elias David; Brkic, Alen; Absolom, Kate; Andvik, Elisabeth; Beernaert, Kim & Cresswell, Kathrin
[Show all 21 contributors for this article]
(2026).
Balancing ideals and realities: health care professionals’ perspectives of and attitudes toward digital patient-centered cancer care.
Quality of Life Research.
ISSN 0962-9343.
35.
doi:
10.1007/s11136-025-04103-w.
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Purpose Patient-centered care (PCC) improves quality of life, symptom management and healthcare outcomes in oncology. However, integration into routine cancer care remains limited. Digital solutions using patient-reported outcome measures (PROMs) offer a potential mechanism to operationalize PCC. This study explored healthcare professionals’ (HCPs) pre-implementation perspectives on using digital PROMs to support PCC in Norwegian oncology outpatient clinics, informing the design and implementation strategies of the European MyPath digital solution. Methods Semi-structured interviews (n = 29) and three focus groups (n = 16) were conducted with varied HCPs across four Norwegian hospitals. Interviews explored perceptions of PCC, experiences with PROMs, and requirements for digital implementation. Data were analyzed using thematic analysis, combining inductive and deductive coding guided by the TPOM framework. Results Four themes emerged: (1) balancing PCC with disease-centered practices, (2) integrating PCC into daily routines, (3) customization and patient acceptance of digital tools, and (4) combining patient-reported data with clinical autonomy. HCPs viewed digital PROMs as promising for facilitating PCC but emphasized that successful implementation requires workflow alignment, adaptable digital solutions, and strong stakeholder engagement. Concerns included patient digital literacy, workload implications, and overreliance on PROMs at the expense of direct patient interaction. Conclusion Our findings highlight a tension between HCPs’ needs for technical functionality and workflow alignment, and the support required to adapt their practice to fully realize PCC through digital tools. Integrating PCC successfully requires organizational, cultural, and workflow adaptations, alongside active HCP engagement in design and implementation. These changes are essential to reposition PCC as an integral rather than competing component of high-quality cancer care.
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Paulsen, Ørnulf; Hjermstad, Marianne Jensen & Kaasa, Stein
(2025).
Design and delivery of clinical trials: from idea to final publication.
In Higginson, Irene J; Bruera, Eduardo; Costantini, Massimo; Currow, David; Larkin, Philip J & Preston, Nancy (Ed.),
Research Methods in Palliative, Supportive, and End-of-Life Care.
Oxford University Press.
ISSN 9780191924644.
p. 82–98.
doi:
10.1093/9780191924644.003.0009.
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Clinical trials are essential to advance clinical practice with RCTs being the gold standard for evaluation of health care interventions. Patients in palliative, supportive, and end-of-life care represent vulnerable populations for research. Thus, clinical trials involving these populations must be carefully planned. This chapter gives an introduction on how to plan and run a clinical trial. With practical advice, it provides guidance ranging from the initial idea through to the stepwise process of planning, organizing, and conducting a trial. The chapter also highlights some pitfalls to be avoided during these processes.
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Erichsen, Marianne; Solheim, Tora S; Ottestad, Inger; Paur, Ingvild; Sande, Rikka Frøyen & Nygaard, Astrid
[Show all 17 contributors for this article]
(2025).
Parenteral Nutrition in Patients with Incurable Cancer: Exploring the Heterogenous and Non-Randomised Clinical Landscape.
Current Oncology.
ISSN 1198-0052.
32(11).
doi:
10.3390/curroncol32110644.
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Background: There is an insufficient knowledge base for optimal parenteral nutrition (PN) use for patients with incurable cancer, leading to vague guidelines and varied practices. The aim of the study is to describe the practices and actual outcomes of PN in patients with incurable cancer at Norwegian hospitals.
Methods: This multicentre study retrospectively reviewed 507 deceased patients (>18 years) receiving PN between 2011 and 2017. Data were collected from PN initiation until death, and analyses were descriptive.
Results: Fifty-one percent had upper and lower gastrointestinal cancers, and the main PN indications were insufficient intake (75%) and gastrointestinal malfunction (47%). Sixty-seven percent received no anticancer treatment. Forty-three (8%) received PN as temporary bridging to anticancer treatment, of whom fifteen (35%) resumed or initiated treatment. The median PN dose corresponded to 53% of estimated energy requirements, and 94% of the patients had complementary energy intake. The most common reason for discontinuation was expected imminent death (47%). While common symptoms during PN were nausea (52%), vomiting (46%), and oedema (37%), 15% reported improved wellbeing. Conclusions: In this real-world cohort, up to 80% of the patients would not meet the eligibility criteria of previous trials due to cancer diagnosis and treatment, gastrointestinal tract function, weight loss criteria or complications such as ascites. This study highlights the heterogeneity in how patients with incurable cancer receive PN, and emphasises the importance of individualised PN treatment, carefully and safely managed to meet the patients’ palliative care situation. Future real-world pragmatic patient-centred protocols bridging the gap between clinical trials and patients in clinical practice are warranted.
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Festvåg, Line Elida; Sverre, Beate Lie; Paulsen, Ørnulf & Eilertsen, Grethe
(2025).
The value of home-based advance care planning in addressing existential concerns among older Norwegian patients with cancer and their relatives: A narrative ethnographic study.
Palliative Care & Social Practice.
19,
p. 1–12.
doi:
10.1177/26323524251330658.
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Background:
The importance of holistic and person-centered palliative care is widely recognized, but the existential dimensions remain less focused. There is a need for more knowledge about the existential content in advance care planning (ACP) and the significance thereof in the context of home-based palliative care from the perspective of patients and their relatives.
Objective:
This study aimed to explore home-based ACP as an existential conversation when conducted as a part of a palliative-care coordination meeting, and how older home-dwelling patients with advanced cancer and their relatives experience its significance.
Design:
A narrative ethnographic design was employed.
Methods:
The reported empirical material is based on participant observations of the home-based ACP conversations and follow-up interviews with eight patients and their relatives. The analytical approach was guided by the theoretical framework of narrative ethnography.
Results:
The ACP conversations strongly supported the patients and their relatives in discussing existential concerns, such as existential fear, lived lives, and decision-making at the end of life. The significance of these conversations extended beyond the initial conversation by profoundly influencing subsequent family interactions and enhancing their ability to make informed and meaningful decisions regarding future medical treatment and care.
Conclusion:
Home-based ACP can be a valuable approach for addressing the existential concerns of older patients and their relatives in the final stages of life. Home-based ACP conversations start a process that continues within the family context and affects their relational dynamics and communication patterns. This study indicates that the home environment fosters discussions about past, present, and future lives, shaping the content and outcomes of home-based ACP.
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Hjermstad, Marianne Jensen; Pirnat, Aleksandra; Aass, Nina Kathrine; Andersen, Sigve; Astrup, Guro Lindviksmoen & Dajani, Olav
[Show all 19 contributors for this article]
(2024).
PALLiative care in ONcology (PALLiON): A cluster-randomised trial investigating the effect of palliative care on the use of anticancer treatment at the end of life.
Palliative Medicine.
ISSN 0269-2163.
38(2),
p. 229–239.
doi:
10.1177/02692163231222391.
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Background: Effects on anticancer therapy following the integration of palliative care and oncology are rarely investigated. Thus, its potential effect is unknown.
Aim: To investigate the effects of the complex intervention PALLiON versus usual care on end-of-life anticancer therapy.
Design: Cluster-randomised controlled trial (RCT), registered at ClinicalTrials.gov (No. NCT01362816). The complex intervention consisted of a physician education program enhancing theoretical, clinical and communication skills, a patient-centred care pathway and patient symptom reporting prior to all consultations. Primary outcome was overall use, start and cessation of anticancer therapy in the last 3 months before death. Secondary outcomes were patient-reported outcomes. Mixed effects logistic regression models and Cox proportional hazard were used.
Setting: A total of 12 Norwegian hospitals (03/2017-02/2021).
Participants: Patients ⩾18 years, advanced stage solid tumour, starting last line of anticancer therapy, estimated
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Festvåg, Line Elida; Sverre, Beate Lie; Paulsen, Ørnulf & Eilertsen, Grethe
(2024).
Advance care planning with older Norwegian adults in their homes: a narrative ethnographic study.
BMC Palliative Care.
23(1).
doi:
10.1186/s12904-024-01378-7.
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Background: The aim of advance care planning (ACP) is to enable patients to define and discuss their values and preferences to ensure that the care they receive is consistent with their needs and wishes. Most studies of ACP with older adults focus on conversations conducted in institutions. This study aimed to explore how ACP with older patients is carried out and experienced by healthcare professionals when the conversations occur in their private homes.
Methods: The data were obtained from participant observations of ACP conversations in the homes of eight older patients with advanced cancer, which also involved relatives and healthcare professionals. Additionally, ethnographic interviews were conducted with the healthcare professionals. We undertook a narrative analysis of what was said, and how the individuals acted and interacted.
Results: The home influenced both the substance and form of the ACP conversations. The patients and relatives welcomed the healthcare professionals as guests and were encouraged to share their perceptions of their current situation, joys and worries. Their values were often implicit in their stories about past experiences. The planning mainly focused on life-prolonging treatment and the preferred future place of care. Several patients were not ready to discuss one or more ACP issues. The palliative-care-team physician addressed the patients' readiness for ACP by asking for permission to move on to a different topic, shifting between serious and lighter topics, and using elements from the home as 'door openers' to continue conversations. ACP conversations were an essential basis for future palliative care and cooperation, giving important additional information about the patient and their relatives.
Conclusion: Conducting the ACP conversations in the patients' homes ensured a homely atmosphere that facilitated a caring approach when sensitive issues were discussed, and in turn supported the identification of important personal values. The healthcare professionals expressed that the ACP conversations represented an essential common reference point and provided a shared awareness of the expected disease trajectory and the values, preferences and needs of the patient. These findings are particularly important given that many older patients struggle to verbalize or form an opinion on issues affecting their future.
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Yri, Olav Erich; Astrup, Guro Lindviksmoen; Karlsson, Astrid Telhaug; Helvoirt, Rene van; Hjermstad, Marianne Jensen & Husby, Kristin Moksnes
[Show all 15 contributors for this article]
(2024).
Survival and quality of life after first-time diagnosis of brain metastases: a multicenter, prospective, observational study.
The Lancet Regional Health - Europe.
49,
p. 1–15.
doi:
10.1016/j.lanepe.2024.101181.
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Background: A major concern in anticancer treatment (ACT) of brain metastases (BM) is exposing patients with short expected survival to treatments that negatively impact on quality of life (QoL). Such futile ACT at the end of life is time-consuming and burdensome for patients and their families and entails unnecessary healthcare costs. Refraining from ACT is challenging for both physicians and patients. This study aimed to provide real-life data on survival after BM diagnosis and patient reported outcomes (PROs) after ACT to identify risk factors for futile treatment and to support BM treatment decisions.
Methods: This multi-center, prospective, observational study recruited consecutive patients with first-time BM from November 2017 to March 2021. Patients were followed until death or study end (October 1st, 2023). Clinical factors associated with survival were analyzed by the Cox' proportional hazards model. Changes in PROs after BM treatment were described according to Eastern Cooperative Oncology Group (E
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Jakobsen, Gunnhild; Sjue, Karin; Paulsen, Ørnulf; Kaasa, Stein; Hjermstad, Marianne Jensen & Klepstad, Pål
(2022).
Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer-a double-blind, randomized placebo-controlled clinical multicenter phase IV trial.
Supportive Care in Cancer.
ISSN 0941-4355.
31.
doi:
10.1007/s00520-022-07537-x.
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Purpose: Insomnia is frequent in patients with advanced cancer, and a variety of pharmacological agents is used to treat this condition. Still, few clinical trials have investigated the effectiveness of pharmacological sleep therapies in this patient group. We aimed to study the short-term effectiveness of zopiclone on sleep quality in patients with advanced cancer who report insomnia.
Methods: A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase IV clinical trial in adult patients with metastatic malignant disease and insomnia. Patients were treated with zopiclone or placebo for six subsequent nights. Primary end point was patient-reported sleep quality during the final study night (NRS 0-10). Secondary end points were patient-reported sleep onset latency (SOL) and total sleep time (TST).
Results: Forty-one patients were randomized, with 18 being analyzed in the zopiclone group and 21 in the placebo group. Median age was 66, median Karnofsky performance score was 80, and 56% were male. Mean sleep quality at end of study was 2.9 (CI 2.3 to 3.8) in the zopiclone group and 4.5 (CI 3.6 to 5.4) in the placebo group (p = 0.021). At end of study, SOL was significantly different between the treatment groups: zopiclone 29 min (CI 13 to 51) and placebo 62 min (CI 40 to 87) (p = 0.045). TST was not significantly different across groups: zopiclone 449 min (403 to 496) and placebo 411 min (CI 380 to 440) (p = 0.167).
Conclusion: Zopiclone improved short-term patient-reported sleep quality in this cohort of patients with advanced cancer.
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Jakobsen, Gunnhild; Engstrøm, Morten; Hjermstad, Marianne Jensen; Rosland, Jan Henrik; Aass, Nina Kathrine & Albert, Eva
[Show all 10 contributors for this article]
(2021).
The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial.
Supportive Care in Cancer.
ISSN 0941-4355.
29(4),
p. 2047–2055.
doi:
10.1007/s00520-020-05693-6.
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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.
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Dolan, Ross D.; Laird, Barry J.A.; Klepstad, Pål; Kaasa, Stein; Horgan, Paul G. & Paulsen, Ørnulf
[Show all 7 contributors for this article]
(2019).
An exploratory study examining the relationship between performance status and systemic inflammation frameworks and cytokine profiles in patients with advanced cancer.
Medicine.
ISSN 0025-7974.
98(37),
p. 1–7.
doi:
10.1097/MD.0000000000017019.
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The role of cytokines in the systemic inflammatory response (SIR) is now well established. This is in keeping with the role of the SIR in tumorigenesis, malignant spread, and the development of cachexia. However, the relationship between performance status/systemic inflammation frameworks and cytokine profiles is not clear. The aim of the present study was to examine the relationship between the Eastern cooperative oncology group performance status/modified Glasgow prognostic score (ECOG-PS/mGPS) and cooperative oncology group performance status/neutrophil platelet score (ECOG-PS/NPS) frameworks and their cytokine profile in patients with advanced cancer.This was a retrospective interrogation of data already collected as part of a recent clinical trial (NCT00676936). The relationship between the independent variables (ECOG-PS/mGPS and ECOG-PS/NPS frameworks), and dependent variables (cytokine levels) was examined using independent Mann-Whitney U and Kruskal Wallis tests where appropriate.Of the 40 patients included in final analysis the majority had evidence of an SIR assessed by mGPS (78%) or NPS (53%). All patients died on follow-up and the median survival was 91 days (4-933 days). With increasing ECOG-PS there was a higher median value of Interleukin 6 (IL-6, P = .016) and C-reactive protein (CRP, P < .01) and lower albumin (P < .01) and poorer survival (P < .001). With increasing mGPS there was a higher median value of IL-6 (P = .016), Macrophage migration inhibitory factor (MIF, P = .010), erythrocyte sedimentation rate (ESR, P < .01) and poorer survival (P < .01). With increasing NPS there was a higher median value of TGF-β (P < .001) and C-reactive protein (P = .020) and poor survival (P = .001). When those patients with an ECOG-PS 0/1 and mGPS0 were compared with those patients with an ECOG-PS 2 and mGPS2 there was a higher median value of IL-6 (P = .017) and poorer survival (P < .001). When those patients with an ECOG-PS 0/1 and NPS0 were compared with those patients with an ECOG-PS 2 and NPS1/2 there was a higher median value of IL-6 (P = .002), TGF-β (P < .001) and poorer survival (P < .01).In patients with advanced cancer IL-6 was associated with the ECOG-PS/mGPS and ECOG-PS/NPS frameworks and survival in patients with advanced cancer. Therefore, the present work provides supporting evidence that agents targeting IL-6 are worthy of further exploration.
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Jakobsen, Gunnhild; Engstrøm, Morten; Paulsen, Ørnulf; Sjue, Karin; Raj, Sunil Xavier & Thronæs, Morten
[Show all 10 contributors for this article]
(2018).
Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial.
Trials.
19:707(707),
p. 1–9.
doi:
10.1186/s13063-018-3088-3.
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Background Despite the high prevalence of insomnia in patients with advanced cancer, there are no randomized controlled trials on pharmacological interventions for insomnia in this group of patients. A variety of pharmacological agents is recommended to manage sleep disturbance for insomnia in the general population, but their efficacy and safety in adults with advanced cancer are not established. Thus, there is a need to evaluate the effectiveness of medications for insomnia in order to improve the evidence in patients with advanced cancer. One of the most used sleep medications at present in patients with cancer is zopiclone. Methods This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. A total of 100 patients with metastatic cancer who report insomnia will be randomly allocated to zopiclone or placebo. The treatment duration with zopiclone/placebo is 6 consecutive nights. The primary endpoint is patient-reported sleep quality during the final study night (night 6) assessed on a numerical rating scale of 0–10, where 0 = Best sleep and 10 = Worst possible sleep. Secondary endpoints include the mean patient-reported total sleep time and sleep onset latency during the final study night (night 6). Discussion Results from this study on treatment of insomnia in advanced cancer will contribute to clinical decision-making and improve the treatment of sleep disturbance in this patient cohort.
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Paulsen, Ørnulf; Laird, Barry J; Aass, Nina Kathrine; Lea, Tor Erling; Fayers, Peter & Kaasa, Stein
[Show all 7 contributors for this article]
(2017).
The relationship between pro-inflammatory cytokines and pain, appetite and fatigue in patients with advanced cancer.
PLOS ONE.
12(5).
doi:
10.1371/journal.pone.0177620.
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Background Systemic inflammation is associated with reduced quality of life and increased symptoms in patients with advanced cancer. The aims of this study were to examine the relationships between inflammatory biomarkers and the Patient Reported Outcome Measures (PROMs) of pain, appetite and fatigue; and to explore whether levels of baseline biomarkers were associated with changes in these PROMs following treatment with corticosteroids. Material and methods An exploratory analysis was done on a trial examining the analgesic properties of corticosteroids in patients with advanced cancer. Inclusion criteria were: >18 years, taking opioids for moderate or severe cancer pain; pain ≥4 (numerical rating scale 0–10). Serum was extracted and levels of inflammatory biomarkers were assessed. PROMs of pain, appetite and fatigue were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30). The relationships between PROMs and inflammatory biomarkers were examined using Spearman Rho-Rank and multiple regression analysis. Results Data were available on 49 patients. Levels of sTNF-r1, IL-6, IL-18, MIF, MCP-1, TGF-β1, IL-1ra, and C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) were elevated; IL-1β, IL-2, IL-4, IL-8, IL-10, IL-12(p70), interferon-γ, MIP-1α, and TNF-α were below the level of detection. The following correlations were observed: appetite and IL-6 and CRP; fatigue and IL-1ra (rs: 0.38–0.41, p< .01). There was no association between pretreatment biomarkers and effect from corticosteroid treatment. Conclusion In patients with advanced cancer and pain, some pro-inflammatory cytokines were related to appetite and fatigue. Inflammatory biomarkers were not associated with pain or with the efficacy of corticosteroid therapy. Further research examining the attenuation of the systemic inflammatory response and possible effects on symptoms would be of interest.
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Kotlinska-Lemieszek, Aleksandra; Paulsen, Ørnulf; Kaasa, Stein & Klepstad, Pål
(2014).
Polypharmacy in patients with advanced cancer and pain: A european cross-sectional study of 2282 patients.
Journal of Pain and Symptom Management.
ISSN 0885-3924.
48(6),
p. 1145–1159.
doi:
10.1016/j.jpainsymman.2014.03.008.
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Context
Patients with advanced cancer need multiple drugs to control symptoms and to treat cancer and concomitant diseases. At the same time, the goal of treatment changes as life expectancy becomes limited. This results in a risk for polypharmacy, maintained use of unneeded drugs, and drug-drug interactions (DDIs).
Objectives
The aim of the study was to analyze the use of medications and to identify unneeded drugs, and drugs and drug combinations with a risk for DDIs in a cohort of advanced cancer pain patients, defined by a need for a World Health Organization analgesic ladder Step III opioid.
Methods
All drugs taken within a study day by cancer patients receiving opioids for moderate or severe pain (Step III opioids) were analyzed. Nonopioids and adjuvants were analyzed for their use across countries. Unneeded medications and drugs and drug combinations with a risk for pharmacodynamic and pharmacokinetic DDIs were identified on the basis of published literature and electronic resources.
Results
In total, 2282 patients from 17 centers in 11 European countries were included. They received a mean of 7.8 drugs (range 1–20). Over one-quarter used 10 or more medications. The drugs and drug classes most frequently coadministered with opioids were proton pump inhibitors, laxatives, corticosteroids, paracetamol (acetaminophen), nonsteroidal anti-inflammatory drugs, metoclopramide, benzodiazepines, anticoagulants, antibiotics, anticonvulsants, diuretics, and antidepressants. The use of nonopioids and essential adjuvants varied across countries. Approximately 45% of patients received unnecessary or potentially unnecessary drugs, and about 7% were given duplicate or antagonizing agents. Exposures to DDIs were frequent and increased the risk of sedation, gastric ulcerations, bleedings, and neuropsychiatric and cardiac complications. Many patients were exposed to pharmacokinetic DDIs involving cytochrome P450, including about 58% who used a Step III opioid CYP3A4 (izoenzyme of cytochrome P450) substrate, and more than 10% who were given major CYP3A4 inhibitors or inducers.
Conclusion
Patients with cancer treated with a World Health Organization Step III opioid use a high number of drugs. Nonopioid analgesics and corticosteroids are frequently used, but different patterns of use between countries were found. Many patients receive unneeded drugs and are at risk of serious DDIs. These findings demonstrate that drug therapy in these patients needs to be evaluated continuously.
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Paulsen, Ørnulf; Klepstad, Pål; Rosland, Jan Henrik; Aass, Nina Kathrine; Albert, Eva & Fayers, Peter
[Show all 7 contributors for this article]
(2014).
Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial.
Journal of Clinical Oncology.
ISSN 0732-183X.
32(29),
p. 3221–3228.
doi:
10.1200/JCO.2013.54.3926.
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Purpose Corticosteroids are frequently used in cancer pain management despite limited evidence. This study compares the analgesic efficacy of corticosteroid therapy with placebo.
Patients and Methods Adult patients with cancer receiving opioids with average pain intensity ≥ 4 (numeric rating scale [NRS], 0 to 10) in the last 24 hours were eligible. Patients were randomly assigned to methylprednisolone (MP) 16 mg twice daily or placebo (PL) for 7 days. Primary outcome was average pain intensity measured at day 7 (NRS, 0 to 10); secondary outcomes were analgesic consumption (oral morphine equivalents), fatigue and appetite loss (European Organisation for Research and Treatment of Cancer–Quality of Life Questionnaire C30, 0 to 100), and patient satisfaction (NRS, 0 to 10).
Results A total of 592 patients were screened; 50 were randomly assigned, and 47 were analyzed. Baseline opioid level was 269.9 mg in the MP arm and 160.4 mg in the PL arm. At day-7 evaluation, there was no difference between the groups in pain intensity (MP, 3.60 v PL, 3.68; P = .88) or relative analgesic consumption (MP, 1.19 v PL, 1.20; P = .95). Clinically and statistically significant improvements were found in fatigue (−17 v 3 points; P .003), appetite loss (−24 v 2 points; P = .003), and patient satisfaction (5.4 v 2.0 points; P = .001) in favor of the MP compared with the PL group, respectively. There were no differences in adverse effects between the groups.
Conclusion MP 32 mg daily did not provide additional analgesia in patients with cancer receiving opioids, but it improved fatigue, appetite loss, and patient satisfaction. Clinical benefit beyond a short-term effect must be examined in a future study.
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Paulsen, Ørnulf; Aass, Nina Kathrine; Kaasa, Stein & Dale, Ola
(2013).
Do Corticosteroids Provide Analgesic Effects in Cancer Patients? A Systematic Literature Review.
Journal of Pain and Symptom Management.
ISSN 0885-3924.
46(1),
p. 96–105.
doi:
10.1016/j.jpainsymman.2012.06.019.
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Husby, Kristin Moksnes; Kaasa, Stein; Paulsen, Ørnulf; Rosland, Jan Henrik; Spigset, Olav & Dale, Ola
(2012).
Serum concentrations of opiods when comparing two switching strategies to methadone for cancer pain.
European Journal of Clinical Pharmacology.
ISSN 0031-6970.
68(8),
p. 1147–1156.
doi:
10.1007/s00228-012-1228-3.
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Husby, Kristin Moksnes; Dale, Ola; Rosland, Jan Henrik; Paulsen, Ørnulf; Klepstad, Pål & Kaasa, Stein
(2011).
How to switch from morphine or oxycodone to methadone in cancer patients? A randomized clinical phase II trial.
European Journal of Cancer.
ISSN 0959-8049.
47(16),
p. 2463–2470.
doi:
10.1016/j.ejca.2011.06.047.
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Rosland, Jan Henrik; Hofacker, Sebastian von & Paulsen, Ørnulf
(2006).
Den døende pasient (The dying patient).
Tidsskrift for Den norske legeforening (Tidsskriftet).
ISSN 0029-2001.
126(4),
p. 467–470.
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Jakobsen, Gunnhild; Sjue, Karin; Paulsen, Ørnulf; Kaasa, Stein; Hjermstad, Marianne Jensen & Klepstad, Pål
(2022).
Medikamentell behandling av insomni hos kreftpasienter.
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Festvåg, Line Elida; Sverre, Beate Lie; Paulsen, Ørnulf & Eilertsen, Grethe
(2022).
Forhåndssamtale med eldre hjemmeboende pasienter med kreft i sen palliativ fase, deres pårørende og helsepersonell-- en etnografisk studie.
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Paulsen, Ørnulf; Østevik, Svend-Martin Lindland & Haugen, Dagny Renata Faksvåg
(2022).
Hvordan opplever pårørende den lindrende omsorgen mot slutten av livet for kreftpasienter i Telemark?
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Jakobsen, Gunnhild; Kaasa, Stein; Hjermstad, Marianne Jensen; Aass, Nina Kathrine; Klepstad, Pål & Paulsen, Ørnulf
(2021).
Kortikosteroider påvirker ikke søvn hos alvorlig syke kreftpasienter med smerte.
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Hjermstad, Marianne Jensen; Aass, Nina Kathrine; Andersen, Sigve; Brunelli, Cinzia; Dajani, Olav & Ahmed, Herish
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(2020).
PALLiON - PALLiative care Integrated in ONcology: Study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care.
Trials.
21:303,
p. 1–17.
doi:
10.1186/s13063-020-4224-4.
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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.
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Sande, Rikka Frøyen; Thoresen, Lene; Løhre, Erik Torbjørn; Nygard, Astrid Signe; Paulsen, Ørnulf & Ottestad, Inger
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(2019).
Parenteral nutrition therapy in patients with incurable cancer: A retrospective medical chart review of current practice.
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Rationale: Indication for use, dose and duration of parenteral nutrition (PN) in patients with incurable cancer is understudied. The aim of the study was to describe current practice of PN treatment in adult patients with incurable cancer at St. Olavs University Hospital, Trondheim, Norway.
Methods: A retrospective medical chart review of patients with incurable cancer receiving PN between 2011 and 2017 was conducted. Of 271 identified patients, data from the first 78 patients was included in this preliminary analysis. Medical information was collected from start of PN until patients’ death.
Results: The mean (SD) age was 63.5 (12.9) years, 41 women and 37 men. All patients received PN concomitant with anti-cancer treatment at some point in time. The most common indications for PN were “insufficient oral or enteral intake” (n=67) or “gastrointestinal malfunction” (n=17). At start of PN, there were no differences between subgroups in s-albumin, C-reactive protein level, metastatic disease, or ascites. The main reason for discontinuation of PN was imminently dying patient (n=36), patient preferences (n=19), and complications (n=12).
The table presents available data on PN treatment and survival in subgroups defined by duration of PN treatment. Data presented as n or median (Q1-Q3).
Variables < 2 weeks 2 weeks -1 month 1 month - 2 months > 2 months P1 n
Patients (n) 14 20 16 16 66
PN treatment Highest received PN dose, kcal 1100
(612-1600)#,¤ 1600
(1100-2200)# 1600
(1100-1600) 1750
(1450-2200)¤ 0.001 62
Received dose (percentage of estimated energy need) 73 (43-73) 78 (62-101) 69
(50-94) 97
(73-118) 0.03 52
Documented oral food intake, n 9 16 15 15 0.09 55
Survival From start of PN, days 19
(13-74)& 39
(26- 384) 61
(43-115) 168
(88-295)& 0.001 66
From PN termination, days 10
(4-70) 16
(5-358)§ 4.5
(1-70) 2
(1-7)§ 0.016 66
1Kruskal-Wallis test, Dunn’s Post Hoc test; # P=0.04, ¤ p=0.003, & P=0.001, § P=0.02
Conclusion: To our knowledge, this is the first study describing clinical practice with respect to dose, duration and termination of PN in incurable cancer patients. Preliminary data suggest that the use of PN was dynamic and differentiated. Termination of PN was based on expected patient survival, patient preferences, and treatment complications.
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Paulsen, Ørnulf; Haugstøl, Torunn & Rosland, Jan Henrik
(2016).
Palliative team på sykehus.
In Kaasa, Stein & Loge, Jon Håvard (Ed.),
Palliasjon. Nordisk lærebok. 3. utgave.
Gyldendal Akademisk.
ISSN 9788205488403.
p. 139–147.
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Paulsen, Ørnulf; Klepstad, Pål; Rosland, Jan Henrik & Kaasa, Stein
(2012).
Do corticosteroids have immediate analgesic effects in palliative cancer patietns with pain? A randomized placebo-controlled trial.
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Husby, Kristin Moksnes; Kaasa, Stein; Paulsen, Ørnulf; Rosland, Jan Henrik; Spigset, Olav & Dale, Ola
(2011).
Serum concentrations of opioids when comparing two switching strategies to methadone for cancer pain.
Full text in Research Archive
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Moksness, Kristin; Rosland, Jan Henrik; Paulsen, Ørnulf; Klepstad, Pål & Kaasa, Stein
(2010).
How to switch from morphine or oxycodone to methadone. A randomized clinical phase III trial.
Full text in Research Archive
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Moksness, Kristin; Rosland, Jan Henrik; Paulsen, Ørnulf; Klepstad, Pål & Kaasa, Stein
(2010).
How to switch from morphine or oxycodone to methadone. A randomized clinical phase III trial.
Palliative Medicine.
ISSN 0269-2163.
24(4),
p. 23–23.
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Husby, Kristin Moksnes; Dale, Ola; Rosland, Jan Henrik; Paulsen, Ørnulf; Klepstad, Pål & Kaasa, Stein
(2010).
How to switch from morphine or oxycodone to methadone in cancer patients? A randomized clinical phase II trial.
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The stop and go strategy was not more effective nor as safe as the 3 days switch when switching to methadone in cancer patients. A 3 days switch should still be the standard procedure.
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Fyllingen, Even Hovig; Hjermstad, Marianne Jensen; Oldervoll, Line Merethe; Sigurdardottir, Katrin Rut; Kaasa, Stein & Paulsen, Ørnulf
(2008).
Computer-based symptom assessment in palliative cancer care: To what extent is time expenditure influenced by age, gender, educational level and Karnofsky performance status?
Journal of Palliative Medicine.
ISSN 1096-6218.
22(4),
p. 413–413.
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Published
Aug. 6, 2020 12:49 PM
- Last modified
Aug. 6, 2020 12:49 PM
