The European Palliative Care Cancer Symptom Study (EPCCS)

Cancer Clinical Trial

— EPCCS  

Official title:

The European Palliative Care Cancer Symptom Study (EPCCS). A Prospective Data Collection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362816
• Other study ID #: 2010/2945-3
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: August 1, 2016
• Start date: June 2011
• Est. completion date: October 2013

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ministry of Health and Care Services
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1739
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (20)

Lead Sponsor

Collaborator

Norwegian University of Science and Technology

Cantonal Hospital of St. Gallen, Flinders University, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Haukeland University Hospital, Hospital de San Lázaro, Hospital Universitario La Paz, Institut Català d'Oncologia, Kantonsspital Graubünden, Leeds Cancer Centre at St. James, Medical University of Graz, Oslo University Hospital, Rigshospitalet, Denmark, St George's, University of London, The Cleveland Clinic, Turku University Hospital, University Hospital, Ghent, University of Alberta, University of Edinburgh, University of Navarra

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Ekström M, Johnson MJ, Schiöler L, Kaasa S, Hjermstad MJ, Currow DC. Who experiences higher and increasing breathlessness in advanced cancer? The longitudinal EPCCS Study. Support Care Cancer. 2016 Apr 9. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cancer symptoms	assessment and classification system developed by the European Palliative Care Research Collaborative (EPCRC) / European Association for Palliative Care Research Network (EAPC RN)	up to 6 months	No