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Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)
Anna Thit Johnsen1, Morten Aagaard Petersen, Christian Gluud
1The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg Hospital 20D, Bispebjerg Bakke 23, Copenhagen NV DK-2400, Denmark. anna.thit.johnsen@regionh.dk.
Trials
|September 27, 2014
Summary
This study details the statistical analysis plan for the Danish Palliative Care Trial (DanPaCT), investigating early specialized palliative care (SPC) for metastatic cancer patients. The trial aims to assess the impact of early SPC on patient needs and outcomes.
Area of Science:
- Oncology
- Palliative Care
- Clinical Trials
Background:
- Advanced cancer patients experience significant symptoms and unmet needs.
- Early referral to specialized palliative care (SPC) may improve patient outcomes.
- The Danish Palliative Care Trial (DanPaCT) investigates the benefits of early SPC for metastatic cancer patients.
Purpose of the Study:
- To present a detailed statistical analysis plan (SAP) for the DanPaCT clinical trial.
- To prevent outcome reporting bias, selective reporting, and data-driven results.
- To outline the methodology for analyzing primary and secondary outcomes.
Main Methods:
- DanPaCT is a multicenter, parallel-group, superiority clinical trial with 1:1 randomization.
- The primary outcome is the change in a patient-individualized 'primary need' score (EORTC QLQ-C30).
- Secondary outcomes include individual symptom scales and survival; analyses involve multiple imputation and sensitivity analyses.
Main Results:
- The primary data collection for DanPaCT is complete.
- The SAP details statistical models, significance levels, and blinding procedures.
- Discussion includes handling of missing data, multiplicity, and bias.
Conclusions:
- Few trials have investigated the effects of early SPC.
- DanPaCT is pioneering in its investigation of screening-based early SPC for diverse metastatic cancer diagnoses.
- The SAP ensures rigorous analysis of trial data to inform clinical practice.
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