Anna Thit Johnsen1,2, Morten Aagaard Petersen3, Per Sjøgren4, Lise Pedersen3, Mette Asbjoern Neergaard5, Anette Damkier6, Christian Gluud7, Peter Fayers8,9, Jane Lindschou7, Annette S Strömgren3, Jan Bjoern Nielsen10, Irene J Higginson11, Mogens Groenvold3,12. 1. The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. atjohnsen@health.sdu.dk. 2. Department of Psychology, University of Southern Denmark, Campusvej 55, Odense, Denmark. atjohnsen@health.sdu.dk. 3. The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark. 4. Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 5. Palliative Care Team, Department of Oncology, Aarhus University Hospital, Aarhus, Denmark. 6. Palliative Team Fyn, Odense University Hospital, Odense, Denmark. 7. The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. 8. Institute of Applied Health Sciences, University of Aberdeen Medical School, Aberdeen, Scotland, UK. 9. Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway. 10. Palliative Team Herning, Herning Hospital, Herning, Denmark. 11. King's College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK. 12. Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
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 ofCancer 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 earlyspecialized 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.
RCT Entities:
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.
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