The European Palliative Care Cancer Symptom Study (EPCCS) (EPCCS)
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ClinicalTrials.gov Identifier: NCT01362816 |
Recruitment Status :
Completed
First Posted : May 30, 2011
Last Update Posted : August 2, 2016
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Sponsor:
Norwegian University of Science and Technology
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
Tracking Information | |||||||
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First Submitted Date | May 27, 2011 | ||||||
First Posted Date | May 30, 2011 | ||||||
Last Update Posted Date | August 2, 2016 | ||||||
Study Start Date | June 2011 | ||||||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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)
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Original Primary Outcome Measures | Not Provided | ||||||
Change History | |||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | The European Palliative Care Cancer Symptom Study (EPCCS) | ||||||
Official Title | The European Palliative Care Cancer Symptom Study (EPCCS). A Prospective Data Collection | ||||||
Brief 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) | ||||||
Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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 | ||||||
Condition | Cancer | ||||||
Intervention | Not Provided | ||||||
Study 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 |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
1739 | ||||||
Original Estimated Enrollment |
1200 | ||||||
Actual Study Completion Date | October 2013 | ||||||
Actual Primary Completion Date | October 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Norway | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT01362816 | ||||||
Other Study ID Numbers | 2010/2945-3 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Norwegian University of Science and Technology | ||||||
Study Sponsor | Norwegian University of Science and Technology | ||||||
Collaborators |
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Investigators |
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PRS Account | Norwegian University of Science and Technology | ||||||
Verification Date | July 2016 |