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Open Access Study protocol

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

Anna T Johnsen1*, Anette Damkier2, Tove B Vejlgaard3, Jane Lindschou4, Per Sjøgren5, Christian Gluud4, Mette A Neergaard6, Morten Aa Petersen1, Lena E Lundorff7, Lise Pedersen1, Peter Fayers8, Annette S Strömgren9, Irene J Higginson10 and Mogens Groenvold111

Author Affiliations

1 Department of Palliative Medicine, The Research Unit, Bispebjerg Hospital 20D, Bispebjerg Bakke 23, DK-2400 Copenhagen, NV,Denmark

2 Palliative Team Fyn, Odense University Hospital, Odense, Denmark

3 Palliative Team Vejle, Vejle Hospital, Vejle, Denmark

4 Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

5 Department of Oncology, Section of Palliative Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

6 The Palliative Team, Aarhus University Hospital, Aarhus, Denmark

7 Palliative Team Herning, Herning Hospital, Herning, Denmark

8 Institute of Applied Health Sciences, University of Aberdeen Medical School, Foresterhill, Aberdeen, UK

9 Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

10 King’s College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK

11 Institute of Public Health, University of Copenhagen, Copenhagen, Denmark

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BMC Palliative Care 2013, 12:37  doi:10.1186/1472-684X-12-37

Published: 24 October 2013

Abstract

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

Keywords:
Palliative care; End-of-life care; Advanced cancer; Randomised clinical trial; Quality of life; Needs assessment; Patient satisfaction; Cost-effectiveness; Study protocol