Clinical trial NCT01362816: The European Palliative Care Cancer Symptom Study (EPCCS)
Official title: The European Palliative Care Cancer Symptom Study (EPCCS). A Prospective Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Oslo University Hospital
name: Medical University of Graz
name: University of Navarra
name: Hospital Universitario La Paz
name: Cantonal Hospital of St. Gallen
name: Institut Català d'Oncologia
name: University of Alberta
name: Flinders University
name: University Hospital, Ghent
name: The Cleveland Clinic
name: Hospital de San Lázaro
name: Haukeland University Hospital
name: Kantonsspital Graubünden
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: University of Edinburgh
name: Leeds Cancer Centre at St. James
name: Turku University Hospital
name: St George's, University of London
First posted: 2011-05-30
Enrollment: 1739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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)


Eligibility 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

Primary outcomes:
measure: change in cancer symptoms
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Stein Kaasa, Prof MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Marianne J Hjermstad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.