A Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction (DanPaCT)

• Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need [ Time Frame: Baseline, 3 weeks and 8 weeks ] [ Designated as safety issue: No ]
  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.
  
  

• Patients reported symptoms and problems according to the EORTC QLQ-C30 [ Time Frame: Baseline, 3 weeks and 8 weeks ] [ Designated as safety issue: No ]
  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 all the symptoms and problems measured by the EORTC QLQ-C30 and for anxiety and depression measured by the The Hospital Anxiety and Depression Scale (HAD scale)
  
  
• Survival [ Time Frame: From the start of the trial to minimum three months after the end of the intervention. ] [ Designated as safety issue: No ]
  Survival.
  
  
• Economical consequences [ Time Frame: From the start of the trial to minimum three months after the end of the intervention. ] [ Designated as safety issue: No ]
  Economical consequences measured as the expenses to health care services (treatments, hospitalisation, outpatient visits, emergency room visits, and visits with the general practitioner).
  
  
• Patient reported Satisfaction with services provided by the health care system measured with the questionnaire FAMCARE-p16 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  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) in the patients' evaluation of treatment and care provided by the health care system measured by the FAMCARE-p16 and four additional items developed for this trial
  
  

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.