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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
TRYG Foundation
Danish Cancer Society
Information provided by (Responsible Party):
Mogens Groenvold, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01348048
First received: May 2, 2011
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Other: Specialised palliative care (SPC)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: March 2018
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer stage 4 according to the TNM system (for patients with cancer in CNS inclusion criteria is: cancer grade three or four and no possibility of radical treatment)
  • At least 18 years
  • Live in the area of the participating hospitals
  • No contact with specialised palliative care within the previous year
  • At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
  • Four additional symptoms (defined as patients answering, on average, at least 'a little' in any of the 14 function or symptom scales in the EORTC QLQ-C30 questionnaire)
  • Written informed consent

Exclusion Criteria:

  • Do not understand Danish well enough to participate in the study
  • Are judged incapable of co-operating with the trial protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348048

Locations
Denmark
The Palliative Team, Aarhus University Hospital
Aarhus, Denmark, 8000
Department of Palliative Medicine, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Section of Acute Pain Management and Palliative Medicine, Rigshospitalet
Copenhagen, Denmark, 2100
Palliative Team Herning
Herning, Denmark, 7400
Palliative Team Fyn, Odense University hospital
Nyborg, Denmark, 5800
Palliative Team Vejle
Vejle, Denmark, 7100
Sponsors and Collaborators
Bispebjerg Hospital
TRYG Foundation
Danish Cancer Society
Investigators
Principal Investigator: Mogens Groenvold, MD, PhD, DMSc Department of Palliative Medicine, Bispebjerg Hospital
  More Information

Publications:
Responsible Party: Mogens Groenvold, MD, PhD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01348048     History of Changes
Other Study ID Numbers: DanPaCT2011
Study First Received: May 2, 2011
Last Updated: June 12, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Bispebjerg Hospital:
palliative care
end-of-life care
randomized clinical trial
quality of life
needs assessment
patient satisfaction
cost-effectiveness
Screening

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014