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

Research output: Contribution to journalArticle

9 Citations (Scopus)
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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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Standard of Care
Clinical Protocols
Palliative Care
Multicenter Studies
Randomized Controlled Trials
Neoplasms
Therapeutics
Anxiety
Depression
Random Allocation
Health Care Costs
Sample Size
Referral and Consultation
Quality of Life
Delivery of Health Care
Survival

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

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. / Johnsen, Anna T. (Corresponding Author); Damkier, Anette; Vejlgaard, Tove B.; Lindschou, Jane; Sjøgren, Per; Gluud, Christian; Neergaard, Mette A.; Petersen, Morten Aa; Lundorff, Lena E.; Pedersen, Lise; Fayers, Peter; Strömgren, Annette S.; Higginson, Irene J.; Groenvold, Mogens.

In: BMC Palliative Care, Vol. 12, No. 1, 37, 24.10.2013.

Research output: Contribution to journalArticle

Johnsen, AT, Damkier, A, Vejlgaard, TB, Lindschou, J, Sjøgren, P, Gluud, C, Neergaard, MA, Petersen, MA, Lundorff, LE, Pedersen, L, Fayers, P, Strömgren, AS, Higginson, IJ & 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, vol. 12, no. 1, 37. https://doi.org/10.1186/1472-684X-12-37
Johnsen, Anna T. ; Damkier, Anette ; Vejlgaard, Tove B. ; Lindschou, Jane ; Sjøgren, Per ; Gluud, Christian ; Neergaard, Mette A. ; Petersen, Morten Aa ; Lundorff, Lena E. ; Pedersen, Lise ; Fayers, Peter ; Strömgren, Annette S. ; Higginson, Irene J. ; Groenvold, Mogens. / 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. In: BMC Palliative Care. 2013 ; Vol. 12, No. 1.
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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.",
keywords = "Advanced cancer, Cost-effectiveness, End-of-life care, Needs assessment, Palliative care, Patient satisfaction, Quality of life, Randomised clinical trial, Study protocol",
author = "Johnsen, {Anna T.} and Anette Damkier and Vejlgaard, {Tove B.} and Jane Lindschou and Per Sj{\o}gren and Christian Gluud and Neergaard, {Mette A.} and Petersen, {Morten Aa} and Lundorff, {Lena E.} and Lise Pedersen and Peter Fayers and Str{\"o}mgren, {Annette S.} and Higginson, {Irene J.} and Mogens Groenvold",
note = "Funding This work was funded by The Danish foundation TrygFonden [journal number 7-10-0838A] and the Danish Cancer Society [journal number R16-A695]. Acknowledgements We wish to thank the following project nurses for collecting the data: Agnethe Fl{\o}e Nielsen and Sine J{\"u}rgensen Stamm Mikkelsen, Aarhus University Hospital; Lone Thorup R{\o}ge and Grethe Christensen, Herning Sygehus; Berit Schmidt Bigum and Kristina Olesen, Vejle Sygehus; Kirsten Rasmussen, Line Haslund and Merethe Martin, Odense University Hospital; and Katrine Eldrup, Helena Lindholm, Louise Christoffersen and Lisbeth Grave Bendixen, Copenhagen University Hospital (Rigshospitalet). Furthermore, we wish to thank the palliative care teams for participating in the trial. Last, but not least, we wish to thank the patients for their participation.",
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T1 - A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs

T2 - The Danish palliative care trial (DanPaCT) protocol

AU - Johnsen, Anna T.

AU - Damkier, Anette

AU - Vejlgaard, Tove B.

AU - Lindschou, Jane

AU - Sjøgren, Per

AU - Gluud, Christian

AU - Neergaard, Mette A.

AU - Petersen, Morten Aa

AU - Lundorff, Lena E.

AU - Pedersen, Lise

AU - Fayers, Peter

AU - Strömgren, Annette S.

AU - Higginson, Irene J.

AU - Groenvold, Mogens

N1 - Funding This work was funded by The Danish foundation TrygFonden [journal number 7-10-0838A] and the Danish Cancer Society [journal number R16-A695]. Acknowledgements We wish to thank the following project nurses for collecting the data: Agnethe Fløe Nielsen and Sine Jürgensen Stamm Mikkelsen, Aarhus University Hospital; Lone Thorup Røge and Grethe Christensen, Herning Sygehus; Berit Schmidt Bigum and Kristina Olesen, Vejle Sygehus; Kirsten Rasmussen, Line Haslund and Merethe Martin, Odense University Hospital; and Katrine Eldrup, Helena Lindholm, Louise Christoffersen and Lisbeth Grave Bendixen, Copenhagen University Hospital (Rigshospitalet). Furthermore, we wish to thank the palliative care teams for participating in the trial. Last, but not least, we wish to thank the patients for their participation.

PY - 2013/10/24

Y1 - 2013/10/24

N2 - 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.

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KW - Cost-effectiveness

KW - End-of-life care

KW - Needs assessment

KW - Palliative care

KW - Patient satisfaction

KW - Quality of life

KW - Randomised clinical trial

KW - Study protocol

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DO - 10.1186/1472-684X-12-37

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