Exploratory analyses of the Danish Palliative Care Trial (DanPaCT): a randomized trial of early specialized palliative care plus standard care versus standard care in advanced cancer patients
Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.
To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).
We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.
In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item ‘overall satisfaction with the help received from the health care system’ with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).
In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.
KeywordsNeoplasms Palliative care Patient satisfaction Randomized clinical trial Quality of life Depression
We wish to thank patients who participated in the project, the staff involved in the trial, and the students who sent out the questionnaires, entered and compared all data, helped with data management, and made material blind to the investigators: Nicla Rohde Christensen, Ellen Lundorff, Marc Klee Olsen, Charlotte Lund Rasmussen, and Nete Skjødt.
ATJ, MAP, CG, JL, PF, PS, LP, MAN, TBV, AD, IJH, and MG took part in designing the trial and ATJ drafted the protocol. MAP, CG, JL, and PF contributed with special competence in randomized clinical trials and/or statistical analysis, and ATJ, PS, LP, MAN, TBV, AD, IJH, and MG with special competence in palliative care. PS, LP, MAN, TBV, AD, JBN, and MG were clinical investigators and in charge of the data collection, and ASS helped collect data. ATJ was postdoc on the study and project coordinator, did the data management, and made the analysis for this study in collaboration with MAP. MG was principal investigator and received the funding for the trial. ATJ drafted the paper and all authors read, amended, and approved the final manuscript.
This work was funded by the Tryg Foundation (journal numbers 7-10-0838A and 7-12-0754) and the Danish Cancer Society (journal numbers R16-A695 and R114-A7232-14-S3).
Compliance with ethical standards
The protocol was approved by the Ethics Committee for the Capital Region, Denmark (journal number H-3-2010-144), and the Danish Data Protection Agency (journal number BBH-2011-05), and registered at www.clinicaltrials.gov (NCT01348048; https://clinicaltrials.gov/ct2/show/NCT01348048?term=01348048&rank=1; registered May 2011).
Conflict of interest
The authors declare that they have no competing interests.
The funding bodies had no role in the design, conduct, analysis, or reporting of the trial.
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