Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
The trial is a randomised, clinical, multicenter trial including 6 Danish SPC-centres. The
basic principle is that patients with palliative needs (see inclusion criteria) are
identified at oncological departments and randomised to either (i) standard treatment plus
SPC (intervention group) or (ii) standard treatment (control group).
Patients will be identified by the following procedure: A) Each week a research nurse
reviews the medical records of consecutive patients seen in oncological out-patients clinic.
B) Eligible patients are asked to fill out a questionnaire (the screening) that investigates
symptoms and problems. The patients are told that their questionnaire will be evaluated and
that the research nurse will contact some of the patients later on with information about a
RCT. C) Those patients who report at least one palliative need in the questionnaire (see
inclusion criteria) and have four additional symptoms are contacted by the research nurse
who provide the patients with written and verbal information about the RCT. D) Patients who
give informed consent are randomised.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need
The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale score that constitutes the primary need. The primary need can be a need related to the following: physical function, role function, emotional function, pain, shortness of breath, lack of appetite and nausea/vomiting.
Baseline, 3 weeks and 8 weeks
Mogens Groenvold, MD, PhD, DMSc
Department of Palliative Medicine, Bispebjerg Hospital
Denmark: The Regional Committee on Biomedical Research Ethics