The European Palliative Care Cancer Symptom Study (EPCCS)

NCT ID: NCT01362816

Last Updated: 2016-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1739 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role collaborator

University of Navarra

OTHER

Sponsor Role collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

Institut Català d'Oncologia

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Flinders University

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Hospital de San Lázaro

UNKNOWN

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

Kantonsspital Graubünden

OTHER

Sponsor Role collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role collaborator

Leeds Cancer Centre at St. James

UNKNOWN

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stein Kaasa, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Marianne J Hjermstad, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Norwegian University of Science and Technology

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Ekstrom M, Johnson MJ, Schioler L, Kaasa S, Hjermstad MJ, Currow DC. Who experiences higher and increasing breathlessness in advanced cancer? The longitudinal EPCCS Study. Support Care Cancer. 2016 Sep;24(9):3803-11. doi: 10.1007/s00520-016-3207-1. Epub 2016 Apr 9.

Reference Type RESULT
PMID: 27061408 (View on PubMed)

Ekstrom MP, Palmqvist S, Currow DC, Sjogren P, Kurita GP, Jakobsen G, Kaasa S, Hjermstad M. Mild to Moderate Cognitive Impairment Does Not Affect the Ability to Self-Report Important Symptoms in Patients With Cancer: A Prospective Longitudinal Multinational Study (EPCCS). J Pain Symptom Manage. 2020 Aug;60(2):346-354.e2. doi: 10.1016/j.jpainsymman.2020.03.007. Epub 2020 Mar 14.

Reference Type DERIVED
PMID: 32179133 (View on PubMed)

Vagnildhaug OM, Brunelli C, Hjermstad MJ, Strasser F, Baracos V, Wilcock A, Nabal M, Kaasa S, Laird B, Solheim TS. A prospective study examining cachexia predictors in patients with incurable cancer. BMC Palliat Care. 2019 Jun 4;18(1):46. doi: 10.1186/s12904-019-0429-2.

Reference Type DERIVED
PMID: 31164115 (View on PubMed)

Boland JW, Allgar V, Boland EG, Kaasa S, Hjermstad MJ, Johnson MJ. Predictors and trajectory of performance status in patients with advanced cancer: A secondary data analysis of the international European Palliative Care Cancer Symptom study. Palliat Med. 2019 Feb;33(2):206-212. doi: 10.1177/0269216318811011. Epub 2018 Nov 8.

Reference Type DERIVED
PMID: 30404572 (View on PubMed)

Habberstad R, Hjermstad MJ, Brunelli C, Kaasa S, Bennett MI, Pardon K, Klepstad P. Which factors can aid clinicians to identify a risk of pain during the following month in patients with bone metastases? A longitudinal analyses. Support Care Cancer. 2019 Apr;27(4):1335-1343. doi: 10.1007/s00520-018-4405-9. Epub 2018 Aug 13.

Reference Type DERIVED
PMID: 30105665 (View on PubMed)

Paque K, Elseviers M, Vander Stichele R, Pardon K, Hjermstad MJ, Kaasa S, Dilles T, De Laat M, Van Belle S, Christiaens T, Deliens L. Changes in medication use in a cohort of patients with advanced cancer: The international multicentre prospective European Palliative Care Cancer Symptom study. Palliat Med. 2018 Apr;32(4):775-785. doi: 10.1177/0269216317746843. Epub 2017 Dec 15.

Reference Type DERIVED
PMID: 29243546 (View on PubMed)

Hjermstad MJ, Aass N, Aielli F, Bennett M, Brunelli C, Caraceni A, Cavanna L, Fassbender K, Feio M, Haugen DF, Jakobsen G, Laird B, Lohre ET, Martinez M, Nabal M, Noguera-Tejedor A, Pardon K, Pigni A, Piva L, Porta-Sales J, Rizzi F, Rondini E, Sjogren P, Strasser F, Turriziani A, Kaasa S; European Palliative Care Cancer Symptom study (EPCCS). Characteristics of the case mix, organisation and delivery in cancer palliative care: a challenge for good-quality research. BMJ Support Palliat Care. 2018 Dec;8(4):456-467. doi: 10.1136/bmjspcare-2015-000997. Epub 2016 May 31.

Reference Type DERIVED
PMID: 27246166 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010/2945-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.