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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

  • Anna Thit JohnsenEmail author
  • Morten Aagaard Petersen
  • Per Sjøgren
  • Lise Pedersen
  • Mette Asbjoern Neergaard
  • Anette Damkier
  • Christian Gluud
  • Peter Fayers
  • Jane Lindschou
  • Annette S. Strömgren
  • Jan Bjoern Nielsen
  • Irene J. Higginson
  • Mogens Groenvold
Original Article

Abstract

Background

Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.

Objective

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).

Methods

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.

Results

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).

Conclusion

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.

Trial registration

NCT01348048

Keywords

Neoplasms Palliative care Patient satisfaction Randomized clinical trial Quality of life Depression 

Notes

Acknowledgements

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.

Authors’ contribution

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.

Funding

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.

Disclaimer

The funding bodies had no role in the design, conduct, analysis, or reporting of the trial.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Anna Thit Johnsen
    • 1
    • 2
    Email author
  • Morten Aagaard Petersen
    • 1
  • Per Sjøgren
    • 3
  • Lise Pedersen
    • 1
  • Mette Asbjoern Neergaard
    • 4
  • Anette Damkier
    • 5
  • Christian Gluud
    • 6
  • Peter Fayers
    • 7
    • 8
  • Jane Lindschou
    • 6
  • Annette S. Strömgren
    • 1
  • Jan Bjoern Nielsen
    • 9
  • Irene J. Higginson
    • 10
  • Mogens Groenvold
    • 1
    • 11
  1. 1.The Research Unit, Department of Palliative Medicine, Bispebjerg HospitalCopenhagen University HospitalCopenhagenDenmark
  2. 2.Department of PsychologyUniversity of Southern DenmarkOdenseDenmark
  3. 3.Department of Oncology, RigshospitaletCopenhagen University HospitalCopenhagenDenmark
  4. 4.Palliative Care Team, Department of OncologyAarhus University HospitalAarhusDenmark
  5. 5.Palliative Team FynOdense University HospitalOdenseDenmark
  6. 6.The Copenhagen Trial Unit, Centre for Clinical Intervention Research, RigshospitaletCopenhagen University HospitalCopenhagenDenmark
  7. 7.Institute of Applied Health SciencesUniversity of Aberdeen Medical SchoolAberdeenUK
  8. 8.Department of Cancer Research and Molecular Medicine, Faculty of MedicineNorwegian University of Science and TechnologyTrondheimNorway
  9. 9.Palliative Team Herning, Herning HospitalHerningDenmark
  10. 10.King’s College LondonCicely Saunders Institute, Department of Palliative Care, Policy and RehabilitationLondonUK
  11. 11.Department of Public HealthUniversity of CopenhagenCopenhagenDenmark

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