We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The European Palliative Care Cancer Symptom Study (EPCCS) (EPCCS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362816
First Posted: May 30, 2011
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rigshospitalet, Denmark
Oslo University Hospital
Medical University of Graz
University of Navarra
Hospital Universitario La Paz
Cantonal Hospital of St. Gallen
Institut Català d'Oncologia
University of Alberta
Flinders University
University Hospital, Ghent
The Cleveland Clinic
Hospital de San Lázaro
Haukeland University Hospital
Kantonsspital Graubünden
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
University of Edinburgh
Leeds Cancer Centre at St. James
Turku University Hospital
St George's, University of London
Information provided by (Responsible Party):
Norwegian University of Science and Technology
May 27, 2011
May 30, 2011
August 2, 2016
June 2011
October 2013   (Final data collection date for primary outcome measure)
change in cancer symptoms [ Time Frame: up to 6 months ]
assessment and classification system developed by the European Palliative Care Research Collaborative (EPCRC) / European Association for Palliative Care Research Network (EAPC RN)
Not Provided
Complete list of historical versions of study NCT01362816 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The European Palliative Care Cancer Symptom Study (EPCCS)
The European Palliative Care Cancer Symptom Study (EPCCS). A Prospective Data Collection
The rising incidence of cancer and the rapidly increasing number of people living longer with incurable disease, accentuates the need for optimal symptom management throughout the disease trajectory. Thanks to the medical and technological development, and the increased interest in palliative care research, palliative medicine has gradually become more evidence based. Patients with advanced cancer experience multiple symptoms at the time with fluctuating intensity and severity. Pain, fatigue, nausea/vomiting, dyspnea, loss of appetite and depression are among the most common and experienced by more than 50%. However, the prevalence rates of these symptoms vary considerably across studies, with a range from 35 to 90 % for pain as an example. These differences may in part be explained by different assessment tools, study methods and design and population characteristics. There is also lack of agreed-upon, common criteria to describe the main characteristics of a palliative care cancer population and few standardized tools for assessment and classification of symptoms exist. These shortcomings limit the possibility to design randomized controlled treatment trials in palliative care; the optimal way to improve clinical symptom management. To do this, a better understanding of how symptoms evolve and how they should be assessed and classified throughout the palliative care disease trajectory is important, supplemented with registrations of the treatment provided. The primary aim of this international research project the European Palliative Care Cancer Symptom study (EPCCS) is to extend the knowledge about and gain new insight in the prevalence and development of the most frequent cancer related symptoms during the course of disease, in a large sample of palliative care cancer patients. The clinical usefulness of the new assessment and classification system developed by the European Palliative Care Research Collaborative (EPCRC) / European Association for Palliative Care Research Network (EAPC RN) will be examined and data on the organization and delivery of palliative care at participating centers will be collected. The project also aims to further develop and consolidate international research collaboration through the European Palliative Care Research Centre (PRC). Taken together, these efforts will increase the understanding of the palliative disease trajectory and provide necessary knowledge and structure for future randomized controlled trials (RCTs)
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The popuation consists of patients with incurable cancers who are enrolled in a palliative care programme. They will be identified upon referral for non-curative cancer treatment/palliative care to the centre, department, out-patient clinic, daycare centre, hospice, or home-based care, depending on the palliaitve care organization model at the participating centres. Patients will be followed every 4 weeks (3-5) for at least 6 months, or until death
Cancer
Not Provided
Palliative care cancer patients

Inclusion criteria are:

Patient has a cancer diagnosis (radiological, histological, cytological or operative evidence), local, loco-regional or metastatic disease, defined as a palliative care patient; enrolled in a palliative care programme, age 18 years or older, able to provide written informed consent, able to complete the data collection tool, preferably without help, available for follow up registration


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1739
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient has a cancer diagnosis (radiological, histological, cytological or operative evidence)
  2. Local, loco-regional or metastatic disease
  3. Defined as a palliative care patient; enrolled in a palliative care programme
  4. Age 18 years or older
  5. Able to provide written informed consent
  6. Able to complete the data collection tool, preferably without help
  7. Available for follow up registration

Exclusion Criteria:

  1. Patients receiving anti-cancer treatment with a curative intent
  2. Patients who are unable to complete the registration due to language problems or severe physical problems
  3. Patients who have psychotic disorders or obvious cognitive impairment
  4. Patients who cannot come for regular follow-up visits, due to geographical or social reasons
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01362816
2010/2945-3
No
Not Provided
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • Rigshospitalet, Denmark
  • Oslo University Hospital
  • Medical University of Graz
  • University of Navarra
  • Hospital Universitario La Paz
  • Cantonal Hospital of St. Gallen
  • Institut Català d'Oncologia
  • University of Alberta
  • Flinders University
  • University Hospital, Ghent
  • The Cleveland Clinic
  • Hospital de San Lázaro
  • Haukeland University Hospital
  • Kantonsspital Graubünden
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • University of Edinburgh
  • Leeds Cancer Centre at St. James
  • Turku University Hospital
  • St George's, University of London
Principal Investigator: Stein Kaasa, Prof MD Norwegian University of Science and Technology
Principal Investigator: Marianne J Hjermstad, PhD Norwegian University of Science and Technology
Norwegian University of Science and Technology
July 2016