The European Palliative Care Cancer Symptom Study (EPCCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Norwegian University of Science and Technology
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01362816
First received: May 27, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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)


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The European Palliative Care Cancer Symptom Study (EPCCS). A Prospective Data Collection

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • change in cancer symptoms [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    assessment and classification system developed by the European Palliative Care Research Collaborative (EPCRC) / European Association for Palliative Care Research Network (EAPC RN)


Estimated Enrollment: 1200
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT01362816

Contacts
Contact: Marianne Jensen Hjermstad +47 23026828 m.j.hjermstad@medisin.uio.no
Contact: Stein Kaasa +47 72826486 stein.kaasa@ntnu.no

Locations
Norway
Norwegian University of Science and Technology Recruiting
Trondheim, Norway, 7491
Contact: Marianne Jensen Hjermstad    +47 23026828    m.j.hjermstad@medisin.uio.no   
Contact: Stein Kaasa    +47 72826486    stein.kaasa@ntnu.no   
Sponsors and Collaborators
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
Investigators
Principal Investigator: Stein Kaasa, Professor MD Norwegian University of Science and Technology
Principal Investigator: Marianne J Hjermstad, Senior researcher/PhD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01362816     History of Changes
Other Study ID Numbers: 2010/2945-3
Study First Received: May 27, 2011
Last Updated: April 16, 2014
Health Authority: Norway: Ministry of Health and Care Services

ClinicalTrials.gov processed this record on August 26, 2014