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

BMC Palliative Care

Study Protocol

Jane Lindschou¹  Christian Gluud¹  Annette S Strömgren²  Per Sjøgren³  Morten Aa Petersen⁴  Lise Pedersen⁴  Anna T Johnsen⁴  Mogens Groenvold⁵  Peter Fayers⁶  Irene J Higginson⁷  Anette Damkier⁸  Lena E Lundorff⁹  Tove B Vejlgaard^1,10  Mette A Neergaard^1,11 

[1] Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark;Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark;Department of Oncology, Section of Palliative Medicine, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark;Department of Palliative Medicine, The Research Unit, Bispebjerg Hospital 20D, Bispebjerg Bakke 23, DK-2400, Copenhagen, NV, Denmark;Department of Palliative Medicine, The Research Unit, Bispebjerg Hospital 20D, Bispebjerg Bakke 23, DK-2400, Copenhagen, NV, Denmark;Institute of Public Health, University of Copenhagen, Copenhagen, Denmark;Institute of Applied Health Sciences, University of Aberdeen Medical School, Foresterhill, Aberdeen, UK;King’s College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK;Palliative Team Fyn, Odense University Hospital, Odense, Denmark;Palliative Team Herning, Herning Hospital, Herning, Denmark;Palliative Team Vejle, Vejle Hospital, Vejle, Denmark;The Palliative Team, Aarhus University Hospital, Aarhus, Denmark;

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

DOI  :  10.1186/1472-684X-12-37

 received in 2013-09-24, accepted in 2013-10-15,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundAdvanced 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/DesignDanPaCT 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.DiscussionOnly 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 registrationCurrent controlled Trials NCT01348048

【 授权许可】

CC BY   
© Johnsen et al.; licensee BioMed Central Ltd. 2013