A Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction (DanPaCT)
Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||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|
- 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
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Specialised palliative care (SPC) group
Patients continue with their standard treatment (typically they receive treatment in one or more hospitals departments and from their GP). In addition, they are offered a consultation in the SPC out-patient clinic (or at home if the patient cannot attend the hospital) as soon as possible and no more than one week after randomization. If possible, each patient will have at least two contacts to the SPC in the trial period.
Other: Specialised palliative care (SPC)
The interventions given by the SPC centres follow the the WHO and the EAPC guidelines for palliative care. It is not possible in advance to describe the interventions more specifically as these will be adjusted to each particular patient. As part of the study the medical records of all patients in the intervention group will be reviewed with the purpose of describing the interventions given for the different symptoms and problems.
No Intervention: Standard care group
Patients continue with their standard treatment. They are instructed to contact either their GP or their hospital department if they feel that additional treatment or care is needed.
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.
|Contact: Mogens Groenvold, MD, PhD, DMScemail@example.com|
|Contact: Anna T Johnsen, psychologist, PhDfirstname.lastname@example.org|
|The Palliative Team, Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Mette A Neergaard, MD, Ph.D. 8949 4670 email@example.com|
|Sub-Investigator: Mette A Neergaard, MD, PhD|
|Department of Palliative Medicine, Bispebjerg Hospital||Recruiting|
|Copenhagen, Denmark, 2400|
|Contact: Lise Pedersen, MD, DMSc 004535312305 firstname.lastname@example.org|
|Sub-Investigator: Lise Pedersen, MD, DMSc|
|Section of Acute Pain Management and Palliative Medicine, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Per Sjøgren, MD, DMSc 3545 7384 email@example.com|
|Sub-Investigator: Per Sjøgren, MD, DMSc|
|Palliative Team Fyn, Odense University hospital||Completed|
|Nyborg, Denmark, 5800|
|Palliative Team Vejle||Recruiting|
|Vejle, Denmark, 7100|
|Contact: Tove B Vejlgaard, MD 7640 1600 Tove.Vejlgaard@slb.regionsyddanmark.dk|
|Sub-Investigator: Tove Vejlgaard, MD|
|Principal Investigator:||Mogens Groenvold, MD, PhD, DMSc||Department of Palliative Medicine, Bispebjerg Hospital|