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. Johnsen* (Corresponding Author), 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

*Corresponding author for this work

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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.

Original languageEnglish
Article number37
Number of pages6
JournalBMC Palliative Care
Volume12
Issue number1
DOIs
Publication statusPublished - 24 Oct 2013

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Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Johnsen, A. T., Damkier, A., Vejlgaard, T. B., Lindschou, J., Sjøgren, P., Gluud, C., Neergaard, M. A., Petersen, M. A., Lundorff, L. E., Pedersen, L., Fayers, P., Strömgren, A. S., Higginson, I. J., & Groenvold, M. (2013). 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, 12(1), [37]. https://doi.org/10.1186/1472-684X-12-37