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BMC Palliative Care
Published in: BMC Palliative Care 1/2013

Open Access 01-12-2013 | 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

Authors: Anna T Johnsen, Anette Damkier, Tove B Vejlgaard, Jane Lindschou, Per Sjøgren, Christian Gluud, Mette A Neergaard, Morten Aa Petersen, Lena E Lundorff, Lise Pedersen, Peter Fayers, Annette S Strömgren, Irene J Higginson, Mogens Groenvold

Published in: BMC Palliative Care | Issue 1/2013

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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
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Anna T Johnsen
Anette Damkier
Tove B Vejlgaard
Jane Lindschou
Per Sjøgren
Christian Gluud
Mette A Neergaard
Morten Aa Petersen
Lena E Lundorff
Lise Pedersen
Peter Fayers
Annette S Strömgren
Irene J Higginson
Mogens Groenvold
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Palliative Care / Issue 1/2013
Electronic ISSN: 1472-684X
DOI
https://doi.org/10.1186/1472-684X-12-37

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