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Open Access 01-12-2014 | Update

Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)

Authors: Anna Thit Johnsen, Morten Aagaard Petersen, Christian Gluud, Jane Lindschou, Peter Fayers, Per Sjøgren, Lise Pedersen, Mette Asbjoern Neergaard, Tove Bahn Vejlgaard, Anette Damkier, Jan Bjoern Nielsen, Annette S Strömgren, Irene J Higginson, Mogens Groenvold

Published in: Trials | Issue 1/2014

Abstract

Background

Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialized palliative care (SPC) could offer improvements. The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer will benefit from being referred to ‘early SPC’. DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization. The planned sample size was 300 patients. The primary data collection for DanPaCT is finished. To prevent outcome reporting bias, selective reporting, and data-driven results, we present a detailed statistical analysis plan (SAP) for DanPaCT here.

Results

This SAP provides detailed descriptions of the statistical analyses of the primary and secondary outcomes in DanPaCT. The primary outcome is the change in the patient’s ‘primary need’. The ‘primary need’ is a patient-individualised outcome representing the score of the symptom or problem that had the highest intensity out of seven at baseline assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Secondary outcomes are the seven scales that are represented in the primary outcome, but each scale evaluated individually for all patients, and survival. The detailed description includes chosen significance levels, models for multiple imputations, sensitivity analyses and blinding. In addition, we discuss the patient-individualized primary outcome, blinding, missing data, multiplicity and the risk of bias.

Conclusions

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 metastatic cancer from a broad spectrum of cancer diagnosis.

Trial registration

Clinicaltrials.gov identifier: NCT01348048 (May 2011).

Available only for authorised users

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Title: Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)
Authors: Anna Thit Johnsen
Morten Aagaard Petersen
Christian Gluud
Jane Lindschou
Peter Fayers
Per Sjøgren
Lise Pedersen
Mette Asbjoern Neergaard
Tove Bahn Vejlgaard
Anette Damkier
Jan Bjoern Nielsen
Annette S Strömgren
Irene J Higginson
Mogens Groenvold
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-15-376

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)

Abstract

Background

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Results

Conclusions

Trial registration

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