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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need

Outcome Description:

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.

Outcome Time Frame:

Baseline, 3 weeks and 8 weeks

Safety Issue:

No

Principal Investigator

Mogens Groenvold, MD, PhD, DMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Palliative Medicine, Bispebjerg Hospital

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

DanPaCT2011

NCT ID:

NCT01348048

Start Date:

May 2011

Completion Date:

November 2017

Related Keywords:

  • Metastatic Cancer
  • palliative care
  • end-of-life care
  • randomized clinical trial
  • quality of life
  • needs assessment
  • patient satisfaction
  • cost-effectiveness
  • Screening
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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