Early, integrated palliative rehabilitation improves quality of life of patients with newly diagnosed advanced cancer: The Pal-Rehab randomized controlled trial.

BACKGROUND: Early integration of palliative care into oncology treatment is widely recommended. Palliative rehabilitation has been suggested as a paradigm which integrates enablement, self-management, and self-care into the holistic model of palliative care. AIM: We hypothesized that early integration of palliative rehabilitation could improve quality of life. DESIGN: The Pal-Rehab study (ClinicalTrials.gov NCT02332317) was a randomized controlled trial. The 12-week intervention offered by a specialized palliative care team was two mandatory consultations and the opportunity of participating in an interdisciplinary group program. Supplementary individual consultations were offered, if needed. SETTING/PARTICIPANTS: At Vejle University Hospital, Denmark, adults diagnosed with advanced cancer within the last 8 weeks were randomized 1:1 to standard oncology care or standard care plus intervention. Assessments at baseline and after six and 12 weeks were based on the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). At baseline participants were asked to choose a "primary problem" from a list of QLQ-C30 domains. The primary endpoint was the change in that "primary problem" measured as area under the curve across 12 weeks (T-scores, European mean value = 50, SD = 10). RESULTS: In all, 288 were randomized of whom 279 were included in the modified intention-to-treat analysis (146 in the standard care group and 133 in the intervention group). The between-group difference for the primary outcome was 3.0 (95% CI [0.0-6.0]; p = 0.047) favoring the intervention. CONCLUSION: Early integration of palliative rehabilitation into standard oncology treatment improved quality of life for newly diagnosed advanced cancer patients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02332317, registered on December 30, 2014.

A new model of early, integrated palliative care: palliative rehabilitation for newly diagnosed patients with non-resectable cancer.

PURPOSE: The aim of this paper is to describe a model of palliative rehabilitation for newly diagnosed advanced cancer patients and present data on how it was utilised during a randomised controlled trial (RCT). METHODS: We designed a highly flexible, multidisciplinary model of palliative rehabilitation consisting of a "basic offer" and tailored elements. The model was evaluated in the setting on an RCT investigating the effect of systematic referral to a palliative rehabilitation clinic concurrently with standard oncology treatment or standard treatment alone. The basic offer of palliative rehabilitation was two consultations and a 12-week possibility of contacting a palliative rehabilitation team, if needed. In addition, patients and family caregivers could be offered participation in a 12-week patient/caregiver school combined with individually tailored physical exercise in groups, individual consultations, or both. Contacts with the palliative rehabilitation team and participant evaluation were registered prospectively. RESULTS: Between December 2014 and December 2017, 132 adults with newly diagnosed advanced cancer were seen in the palliative rehabilitation outpatient clinic. Twenty percent of the participants received the basic offer only (n = 26), 45% additionally participated in the group program (n = 59), and 35% received supplementary individual consultations without participating in the group program (n = 47). The intervention was primarily led by nurses, and the main themes of the individual consultations were coping, pain, and nutrition. When asked if they would recommend the intervention to others in the same situation, 93% of the respondents agreed, 7% partly agreed, and no one disagreed. CONCLUSION: The new model of palliative rehabilitation presented here had a flexibility to meet the needs of the participants and led to a very high degree of patient satisfaction. It could serve as an inspiration to other cancer centres wanting to integrate palliative care into standard oncology services.

A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer: the Pal-Rehab study protocol.

BACKGROUND: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer. METHODS: This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences. DISCUSSION: To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02332317 , registered retrospectively on December 30, 2014. One study participant had been enrolled at the time.

Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer: The Danish Palliative Care Trial.

BACKGROUND: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. AIM: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. SETTING/PARTICIPANTS: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival. RESULTS: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect. CONCLUSION: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.

A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol.

BACKGROUND: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to 'early SPC'. METHODS/DESIGN: DanPaCT is a clinical, multicentre, parallel-group superiority trial with balanced randomisation (1:1). The planned sample size is 300 patients. Patients are randomised to specialised palliative care (SPC) plus standard treatment versus standard treatment. Consecutive patients from oncology departments are screened for palliative needs with a questionnaire if they: a) have metastatic cancer; b) are 18 years or above; and c) have no prior contact with SPC. Patients with palliative needs (i.e. symptoms/problems exceeding a certain threshold) according to the questionnaire are eligible. The primary outcome is the change in the patients' primary need (the most severe symptom/problem measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Secondary outcomes are other symptoms/problems (EORTC QLQ-C30), satisfaction with health care (FAMCARE P-16), anxiety and depression (the Hospital Anxiety and Depression scale), survival, and health care costs. DISCUSSION: Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with a broad spectrum of cancer diagnosis. TRIAL REGISTRATION: Current controlled Trials NCT01348048.

[Educational needs of physicians and nurses working in palliative care]. / Uddannelsesbehov hos laeger og sygeplejersker inden for palliativ pleje og behandling.

INTRODUCTION: The WHO definitions of palliative care have been adopted in Denmark and implemented in the national guidelines. The aim of this study was to assess the educational needs of doctors and nurses in palliative care in a Danish county hospital and the related primary care sector. MATERIALS AND METHODS: A self-administered questionnaire was mailed to an anonymous cross-section of hospital nurses and doctors, home care nurses and GPs in the related primary care sector. The questions concerned the type of education obtained in the area and priorities for education in communication, supervision, pain and other typical symptoms in the terminally ill, as well as bereavement and grief therapy. The responses were compared by chi 2 statistics. RESULTS: 347 (76%) of those surveyed responded to the questionnaire. 81% of them were actually caring for a terminally ill or dying patient, and another 13% had done so within the past six months. The doctors, especially the hospital doctors, had generally received less education in the area surveyed than the nurses had and generally prioritized education lower than the nurses did; 44% of the respondents agreed completely or partially that they found it difficult to get up-to-date information on symptom control in palliative care. DISCUSSION: The findings indicate a profound need for education in palliative care. Doctors reported having received less education in this area than nurses had, and they also perceived a lower priority for education than nurses did. Particularly worrisome is the level of education of hospital doctors.

Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT).

BACKGROUND: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to 'early SPC'. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here. RESULTS: This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient's 'primary need'. The 'primary need' is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias. CONCLUSIONS: Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with metastatic cancer from a broad spectrum of cancer diagnosis. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01348048 (May 2011).

Breakthrough cancer pain: an observational study of 1000 European oncology patients.

CONTEXT: Breakthrough pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. OBJECTIVES: The aim of this study was to characterize breakthrough pain in a diverse population of cancer patients. METHODS: The study involved 1000 cancer patients from 13 European countries. Patients were screened for breakthrough pain using a recommended diagnostic algorithm and then questioned about the characteristics and management of their pain. RESULTS: Of the 1000 patients, 44% reported incident pain, 41.5% spontaneous pain, and 14.5% a combination. The median number of episodes was three a day. The median time to peak intensity was 10 minutes, with the median for patients with incident pain being five minutes (P < 0.001). The median duration of untreated episodes was 60 minutes, with the median for patients with incident pain being 45 minutes (P = 0.001). Eight hundred six patients stated that pain stopped them doing something, 66 that it sometimes stopped them doing something, and only 107 that it did not interfere with their activities. Patients with incident pain reported more interference with walking ability and normal work, whereas patients with spontaneous pain reported more interference with mood and sleep. As well, 65.5% of patients could identify an intervention that improved their pain (29.5%, pharmacological; 23%, nonpharmacological; 12%, combination). Regarding medications, 980 patients were receiving an opioid to treat their pain, although only 191 patients were receiving a transmucosal fentanyl product licensed for the treatment of breakthrough pain. CONCLUSION: Breakthrough cancer pain is an extremely heterogeneous condition.

Something's ironic in Denmark: an otherwise progressive welfare state lags well behind in care of patients at the end of life.

Tremendous strides have been made in the last two decades with regard to the quality of palliative care available to patients at the end of life. But progress has not been uniform, even among countries in the same region of the world. The objective of this study is to describe, in a comparative context, the current status of end-of-life palliative care in Denmark using quantitative research published in the past five years. This study's conclusions, based on a synthesis of the research, suggest that despite its well earned reputation as a generally progressive welfare state, Denmark tends to trail well behind its European neighbors when it comes to end-of-life care. Understanding the cultural forces that underlie this reality may help Danish health care professionals and policy makers overcome the barriers that stand in the way of providing state-of-the-art medical care to patients who suffer at the end of life.

Multi-centre European study of breakthrough cancer pain: pain characteristics and patient perceptions of current and potential management strategies.

This study involved 320 cancer patients from four Northern European countries. Patients with breakthrough pain were questioned about the characteristics of their pain, the current management of their pain, and the acceptability/utility of alternative routes of administration. The median number of episodes was 3/day. Forty-four percent patients reported incident-type pain, 39% spontaneous-type pain, and 17% a combination of these pains. The median duration was 60 min, and the median time to peak intensity was 15 min. Three percent patients reported "mild" pain, 37% "moderate" pain, and 60% "severe" pain. Ninety percent patients stated that the pain interfered with their daily activities. All patients were using opioids as rescue medication (mainly oral morphine/oxycodone), whilst 28% patients were using non-opioids, and 50% patients were using non-pharmacological interventions. Only 55% patients took rescue medication every time they experienced breakthrough pain. Sixty-five percent patients would definitely consider using an oral transmucosal product; patients from Denmark were less likely to answer positively, and a positive response was associated with previous use of the route for breakthrough pain. Seventy-three percent patients reported regular oral problems. Forty-two percent patients would definitely consider using an intranasal product, with 26% patients stating they would definitely not use such a preparation; patients from Denmark and Sweden were less likely to answer positively, and a positive response was associated with male gender, and previous use of the route. Forty-four percent patients reported regular nasal problems. Sixty percent patients would definitely consider using a subcutaneous product, and 44% patients would definitely consider using an intrapulmonary product.

[Specialised palliative medicine...why, where and how?]. / Specialiseret palliativ medicin...hvorfor, hvor og hvordan?

Palliative medicine is the medical part of total palliative care and has been a specialty of its own in United Kingdom since 1987. The development of palliative care has been slower in Denmark. The Danish Medical Association for Palliative Medicine was founded in 2001 and in 2003 initiated a theoretical specialist course in palliative medicine with participants from the 5 Nordic countries. Hospices and specialist palliative teams have been established but there is a great need for development of palliative care in hospitals and in the primary care, and a huge need for education and training of professionals, including doctors.

[Organisation and development of palliative care in Denmark]. / Organisering og udvikling af den palliative indsats i Danmark.

The development of palliative care started in England where St. Christopher's Hospice opened in 1967. In 1990 palliative care was defined by WHO for the first time. In Denmark development has been retarded and palliative care has not been given high priority by the national health authorities. The first hospice in Denmark opened in 1992, and national guidelines were published in 1999. However, the intentions of the guidelines have not been followed systematically. This article describes the development in Denmark and outlines perspectives on possible future directions.