Norwegian cancer researchers launch a project to improve care for cancer patients with a limited life expectancy

Europe has about 3.5 million new cancer cases per year, and the number is rising. Advances in treatment options have led to more patients getting cured and prolonged survival for those with incurable disease. However, a major concern in cancer care is the rapidly increasing complexity of treatment, which leads to escalating costs threatening the sustainability of the services. One important contributor to this scenario is the increasing use of chemotherapy during the patient’s last year of life – often without documented efficacy.

Patients receiving intensive oncologic treatment during their final months or weeks have a poorer quality of life than those who receive symptom-directed treatment. Indeed, recent studies show that introducing a palliative care approach at an early stage in patients with the incurable disease may improve their quality of life and even prolong survival.

PALLiON

In 2014, Norway’s four Regional Health Authorities announced a call for cross-regional research projects to strengthen clinical research and health services research. The program was administered through the Research Council of Norway, and cancer research was one of the prioritized areas.

Against the backdrop described above, leading researchers in oncology and palliative care submitted a proposal to test the efficacy of an intervention integrating oncology and palliative care services for cancer patients with a life expectancy of less than one year – PALLiON. The proposal was highly ranked and received €3 million (25 million NOK) funding for a five-year project. PALLiON was the only cancer-related study to be funded within this call.

Collaborative effort

PALLiON is designed as a national, multi-centre, cluster-randomized trial. This means that the intervention is performed at an institutional level, with six hospitals forming the ‘active cluster’ in which the intervention takes place. Six matching hospitals constitute the ‘control cluster’. The 12 hospitals have been recruited from all health care regions in Norway and range from small, local hospitals to large university clinics. A total of 550 patients who are receiving chemotherapy and have a life expectancy of less than one year will be included in the study.

PALLiON will be coordinated from Oslo University Hospital, with Professor Jon Håvard Loge as Principal Investigator. The Project Management group has members from the University Hospitals in Bergen, Trondheim, and Oslo, supported by a distinguished international reference group.

Complex intervention

The intervention to be tested in the PALLiON study consists of three parts: Systematic electronic assessment of symptoms, implementation of an integrated care pathway, and an educational program for oncologists and palliative care physicians.

Pain, fatigue, loss of appetite and other distressing symptoms are common in patients with advanced cancer. Lack of a systematic assessment has been identified as one of the barriers to effective symptom control. In PALLiON, symptoms will be frequently and systematically assessed by means of EIR, a computer program developed at the European Palliative Care Research Centre (PRC) at the Norwegian University of Science and Technology in Trondheim.

The integrated care pathway gives an outline of the patient pathway, integrating oncologic treatment, palliative care and end-of-life care, and hospital as well as community care. The aim of the pathway is to promote early integration of the palliative care approach, and to reduce the variability in clinical practice.

The educational program is tailored to the other elements of the intervention but puts the main emphasis on communication, prognostication and symptom management.

Project goals

Combined, the three elements of the intervention are expected to improve symptom management, improve quality of life for the patients and their families, and empower them to play an active part in decision-making. We also hypothesize that the intervention will lead to reduced hospital stays and increased use of community-based care in the final months of life. The main outcome measure of the project will be the proportion of patients treated with chemotherapy in the last three months of life.

The detailed study protocol is under preparation. This also includes assessment of all study sites at baseline. A study organization has been set up at Oslo University Hospital, and interdisciplinary teams are working on the different elements of the intervention. Local study coordinators and groups are being established at all project sites.

Inclusion of patients will start in September 2016.

 

Dagny Faksvåg Haugen

Lead Consultant, Head of Centre, Professor of Palliative Medicine

Regional Centre of Excellence for Palliative Care, Western Norway,

Haukeland University Hospital, and Department of Clinical Medicine, University of Bergen, Bergen, Norway

Tel: +47 55 97 58 31

dagny.haugen@helse-bergen.no

www.helse-bergen.no/palliasjon

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