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In EPAAC the aim was to provide a framework for identifying and sharing information, capacity and expertise in cancer prevention and control. Each country should be supported in their work of developing national cancer plans, and it is an aim to reduce inequalities in cancer screening, treatment and palliative care.
EPAAC was launched by the EU in 2009, and is a joint action with the aim of supporting European countries in their efforts to prevent and control cancer.
The work in EPAAC is performed by over 90 collaborating partners. The EAPC, NTNU, and the Norwegian directorate of health are contributing in work package 7, objective 1.2: To improve treatment, symptom assessment and follow-up of palliative care through a standardised assessment methodology (PRO) and evidence based guidelines.
Two experts meetings have been arranged related to the EPAAC deliverables, both in Milan, Italy. The first in January 2012 and the second in May 2013.
PRC contributed with a report on assessment methods and guidelines for symptom management, regarding the symptoms pain, depression and cachexia.
At the EPAAC Open Forum in Ljubljana in November 2013, the EPAAC publication, Boosting Innovation and Cooperation in European Cancer Control: Key Findings from the European Partnership for Action Against Cancer was launched. The publication is available on the EPAAC website.
In February 2014, EPAAC was officially completed, and a new EU Joint Action in Comprehensive Cancer Control was launched, CANCON (2014-2017).
In June 2013, a "Spotlight on" article was published in Cancer World, the magazine of European School of Oncology (ESO), addressing the following questions regarding EPAAC: Did EPAAC deliver on its aim of helping EU member states improve the way they organise and deliver cancer prevention, screening and care? What are the implications for collaborating over cancer in the future? Read the article here(PDF).
Full title: RCT comparing the analgesic efficacy of 4 therapeutic strategies based on 4 different major opioids (fentanyl, oxycodone, buprenorphine vs morphine) in cancer patients with moderate/severe pain.
PI: Oscar Corli (C.E.R.P., Istituto di Ricerche Farmacologiche Mario Negri, Milano): oscar.corli@marionegri.it
Aim To compare of the analgesic efficacy of 4 treatment strategies based on 4 different strong opioids administered by randomization during a 4 week follow-up period.
Background Strong opioids, although formally part the 3rd step of WHO analgesic ladder, not always yield identical clinical effects (analgesia and side effects).
Primary objective
The comparison of the analgesic efficacy of 4 treatment strategies based on 4 different strong opioids (oral morphine as oral oxycodone, transdermal fentanyl and buprenorphine)
Administered by randomization during a 4 week follow-up period
In patients with moderate to severe pain due to the cancer
By using a NRS 0 to 10, measured at each visit as the average pain of the previous 24 hours.
Methods Prospective, open label, multicenter, phase IV, superiority, 4 arms, RCT. The study population is constituted by patients with advanced cancer either for presence of metastasis or substantial local progression.
Results Forty-four centres participated in the trial and recruited 520 patients.
Blood and tissue biomarkers for early detection, diagnosis, staging, surveillance and prediction of therapeutic response.
Background: In the future, we expect that biomarkers in blood, tumour- or normal tissue will be important tools for identifying patients at risk for lung cancer. Furthermore, we expect that such biomarkers will be the basis for individualizing treatment in order to increase efficacy and reduce toxicity from the therapy.
Aim: The objective of the lung cancer biobank is to collect clinical data (e.g. patient characteristics, response to therapy, disease- and symptom development, health related quality of life), tumour tissue, samples of normal lung tissue and blood samples on all patients who undergo examinations on suspicion of lung cancer.
Patients: Almost all patients diagnosed with lung cancer at St. Olavs Hospital, Trondheim University Hospital are included.
Status: In 2015, 69 patients were included in the lung cancer biobank, and the total number of included patients is 729.The material in the biobank is currently used in an international study of genetic predisposition for cachexia, a PhD project regarding miRNA in lung cancer and studies of the role of quantification and characterization of circulating cell free tumour DNA in the diagnosis and classification of lung cancer.
Collected data: Clinical data, tumour tissue, samples of normal lung tissue and blood samples.
CANCON stands for "Development of the European Guide on Quality Improvement in Comprehensive Cancer Control".
Composed of 27 associated partners from across Europe, CANCON will build on the achievements from the previous European Partnership for Action Against Cancer (EPAAC) initiated i 2009. The objective of CANCON is to develop a European guide on quality improvement in comprehensive cancer control that will address various aspects of coordinated and integrated cancer control.
CANCON aims to contribute to improvements in overall cancer control through quality based cancer screening programmes, better integration of cancer care, community-based cancer care approaches and providing concerted efforts in all aspects of survivorship, including palliative care. These key elements will be combined with other relevant aspects of cancer control to form a European Guide on Quality Improvement in Comprehensive Cancer Control. Additionally, these activities will be supplemented by discussion of member states on key cancer control topics in a platform for member states cooperation, which will deliver position papers to be used by member states in shaping their national policies. For all areas, methodology will be developed: first, to assess good practice, and second, to develop methods for quality improvement.
The core work packages in CANCON are:
WP 4: Guide Coordination
WP 5: Platform for Member states' cooperation
WP 6: Integrated cancer care
WP 7: Community-level cancer control
WP 8: Survivorship & Rehabilitation
WP 9: Screening
PRC are involved in WP 6, 7 and 8 (which are also linked together).
During the year 2015, WP6 team has successfully held three group meetings in Ljubljana, Berlin,and Prague. Following is the summary report on what has been agreed upon in 2015:
Cancer networks There are several sorts of cancer networks in Europe: Some are national, and some are cross-border or even Europe-wide; some are specific for a certain type of tumour (e.g. breast cancer),and some are specific for rare tumours; some are structured around an existing Comprehensive Cancer Center in a hub-spokes arrangement; some are more research-orientated, some are more service-orientated. In terms of Integrated Cancer Control it is clearly important to provide on one hand the best possible care to a cancer patient; on the other hand, to provide access to all cancer patients. For these reasons this chapter of the CANCON guide is focused on a type ofnetwork that we call Comprehensive Cancer Care Network (CCCN). After much debate, it has been agreed that, in order to pursue its mission to understand, to treat and to prevent cancer at best for all those living in a certain geographic region, a CCCN must operate through multidisciplinary management teams, must have common management protocols and must have a structured common governance. The core of the chapter will be a description of how a CCCN must be planned and designed; what should be its structure; how it should operate in order not only to optimize the care of cancer patients, but also to ensure and enforce high quality; as well as creating and exploiting opportunities for research. The Guide has identified equity as a major goal in cancer control: it is clear from the above that a CCCN, by offering and favouring access to the same standard of care to all, implies equity in its own very definition. In order to reconcile principles with reality, the chapter will also include findings from a pilot study of a CCCN that is being developed in the Czech Republic.
The project is a Marie Curie Initial Training Network programme financed through the EU 7th FP. It will run from 2010 to 2014.
EURO IMPACT will train 12 full-time early stage researchers and 4 experienced researchers via an international research and training programme. The first training days were arranged in Brussels in July 2011.
To meet the societal challenges accompanying the dramatic increase of patients facing the need for good palliative care in the forthcoming decades, there is an urgent need for enhanced collaborative research training in palliative care. EURO IMPACT aims to develop a multidisciplinary, multiprofessional and intersectorial educational and research training framework in Europe, aimed at monitoring the quality of palliative care in Europe.
The project was coordinated by the End-of-Life Care Research Group at Vrije Universiteit Brussel,Belgium. PIs are Luc Deliens and Lieve Van den Block.
IMPACT is a research project funded by the European Commission's 7th Framework programme. The overall aims are to identify relevant strategies to improve palliative care in dementia and cancer and to monitor factors that contribute to successful implementation of these strategies.
The IMPACT project is coordinated from Nijmegen, Netherlands and consists of 6 work packages(WP).
The first WP concerns the overall coordination of the project, whilst the main aims of the other five WPs, are the following:
WP2: To develop and apply an analytical framework in order to describe how palliative cancer and dementia care services address the needs of their patients.
WP3: To develop implementation strategies that can be used to enhance the quality of palliative cancer and dementia care. The focus will be on areas that have a potential for improvement as documented by quality indicators.
WP4: To test different implementation strategies in a pretest-intervention-posttest study involving a total of 40 home care services, nursing homes, hospitals and hospices in five countries: England, Germany, Italy, Norway and the Netherlands.
WP5: To determine the factors (barriers and facilitators) that influence the success of the selected implementation strategies and quality indicators in improving the organization and quality of palliative care.
WP6: To stimulate reorganization of palliative cancer and dementia care by disseminating the knowledge, results and tools developed within the project.
Professor Lukas Radbruch, Klinik für Palliativmedizin, Universitätsklinikum Bonn, is leading WP 4 Evaluation of the implementation of quality indicators. Professor Stein Kaasa, Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, is leading WP 5 Factors influencing implementation.
The aim of WP4 is to evaluate the effectiveness of implementation strategies used to improve services regarding palliative care. In 2013, 40 services in five countries in Europe have participated in a pretest-intervention-posttest study. First, a set of 23 quality indicators were used to assess the services regarding certain aspects of palliative care in their organization. Each service chose three aspects they would like to improve. Then, improvement strategies were tailored to each of the services. They have now been given a few months to implement the changes while being followed up by consultants working for IMPACT. Finally, in the beginning of 2014, each service will again be assessed using the quality indicators, to see if the improvement strategies have been effective in generating the wanted change.
The aim of WP 5 is to determine the factors (barriers and facilitators) that influence the success of the selected implementation strategies and quality indicators in improving the organization and quality of palliative care. To monitor this, an extensive process evaluation is being conducted at all participating sites during the intervention study.
The final IMPACT conference "Towards integration of palliative care in an age-friendly EU" took place in Brussels on 15 October 2014.
During this conference, a declaration was launched, with 10 recommendations for policy and decision makers in order to improve the quality of and access to palliative care in an age-friendlyEurope. These recommendations are based on recent scientific insights.
EPCCS is an international, multi-centre, prospective data collection with participating centres in Europe, Canada and Australia. The main study objectives are to:
gain a better understanding of the symptom prevalence and symptom variation over time in palliative cancer patients
further evaluate and validate the assessment and classification systems for pain, cachexia and other symptoms
gain knowledge about the organisation and delivery of palliative care within and across nations and institutions
continue the work towards a standardised assessment system to improve symptom management
Principal investigator: Marianne Jensen Hjermstad, assoc. professor Director PRC: Stein Kaasa, professor
The EPCCS is a joint venture between PRC and the EAPC Research Network, and has in part been financed by a grant from one of the Norwegian Health Care authorities.
Background Patients with advanced cancer experience multiple symptoms with fluctuating intensity and severity during the course of the disease. Pain, fatigue, nausea, dyspnoea, constipation, loss of appetite and depression are among the most common symptoms. The prevalence rates for these symptoms vary considerably across studies, and most studies have a cross-sectional design. There are few standardised tools for assessment and classification of symptoms, and there is a lack of agreed-upon, common criteria to describe the major characteristics of a palliative care cancer population.
Design This study is an international, multi-centre, prospective data collection.
Methods The study consists of two parts:
A one-time registration of organisation, delivery and resources for palliative care at each participating centre.
A descriptive, prospective registration of: a) medical and treatment data performed by the health care providers b) self-report of symptoms performed by the patients
1. Centre data: The registration of the centre data will be performed once, upon study start. This registration is the responsibility of the main study responsible at each site. This registration will be in English only and is performed directly on the web. 2. Patient data: All patients will be assessed every 4 (3-5) weeks for 3 months, or until death. The same set of variables will be registered at each assessment.
The registration consists of:
a) Medical and treatment data, registered by the physicians:
Basic data set of medical/clinical variables
Karnofsky Performance Status Scale
Mini-Mental State Examination – 4 item version
Edmonton Classification System for Cancer Pain (ECS-CP)
b) Self-report of symptoms by the patients:
Basic data set of socio-demographic data
Screening items on pain intensity, neuropathic and breakthrough pain, depression and food intake
Edmonton Symptom Assessment System, revised version (ESAS-r)
European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)
The registrations can be performed by laptop computers directly on the web or on paper, depending on the preferences of the centres.
Inclusion Patients who fulfil the inclusion criteria will be included on a consecutive basis. It is of the utmost importance that all patients who are seen by the participating palliative care service are registered, also those who are not included. This will provide a good overview of the patient mixat all participating sites.
Inclusion criteria
Exclusion criteria
1. Patient has a cancer diagnosis(radiological, histological, cytological oroperative 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 atleast once
1. Patients receiving anti-cancer treatment with 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
Patient inclusion: May 2011 – June 2014
Participating centres
Protocol for publications
All use of data will be decided by the study steering committee in collaboration with the project management group (PMG). The individual centres may get access to their own data, provided that this has been approved by the study steering committee and that publications/reports do not compromise publications of overall study results.
All proposals for publication will be subject to publication protocols that should be submitted to the study steering committee and the PMG for approval in order to avoid controversies and duplicate publications. When approved, the data-file will be accessible for the investigators.
To determine whether cancer patients requiring opioids for cancer pain are more satisfied with self-controlled administration of nasal fentanyl (NF) taken on demand than with standard by the clock administration of slow release opioid as pain medication.
Background The WHO pain ladder and the EAPC recommend opioids to be delivered continuously with the necessary dose for optimal pain control, assuming a stable "background pain". However, the concept of background pain has not been supported by subsequent studies, which suggests that cancer pain is highly variable. New nasal formulations of the opioid fentanyl are effective in treating cancer breakthrough pain. In this study we will test if this formulation contributes to better pain control and to reduced frequency of side effects.
A single centre safety – feasibility study of self-administered nasal fentanyl has been conducted for 10 days in 10 cancer patients requiring opioids, and the results suggest that treatment maybe well tolerated, safe and efficient. This study was published in Journal of Opioid Management in 2014.
Methods NFCP is an open, randomised, cross-over, therapeutic confirmatory, phase III study in which the recommended use of oral opioids around the clock will be compared with nasal fentanyl as needed. The primary outcomes are patient satisfaction and preference with treatment.
Patients
Eligible participants are cancer patients with pain >3 (NRS) in the need of opioids.
Status
A total of 108 patients will be recruited. The study re-opened for recruitment in Norway in 2014,and one patient is included.
Contact
To contribute to this study, please contact project manager Morten Thronæs (morten.thrones@ntnu.no).
The WHO analgesic ladder for cancer pain relief is widely accepted as the standard approach in cancer pain control. The foundations for the WHO analgesic ladder were first developed in the early 1980's and following initial use of this method, the guidelines were published in 1986.
Although the WHO ladder has been widely accepted, the need for step 2 of the ladder has been questioned. Research has shown that the second step (weak opioid) may not provide sufficient analgesia in cancer patients and it is safe to start a strong opioid in opioid naive patients.
Although there is some evidence suggesting step 2 of the WHO ladder is unnecessary and ineffective, there is currently insufficient evidence to support modification of the WHO ladder from a three step to a two step (non-opioid straight to strong opioid) approach.
A pilot study examining a novel two step approach versus the traditional three step approach of the WHO analgesic ladder showed that patients in the two step arm achieved pain control more quickly than those in the three step arm. In the three step arm hospital admissions were more common due to poor pain control. Following on from the pilot study, a definitive randomised trial can now be conducted comparing a two step approach (non-opioid analgesia:strong opioid) versus the standard three step approach (non-opioid analgesia:weak opioid:strong opioid).
Aims
Primary objective: to establish whether a two step approach to cancer pain relief can achieve stable pain control more quickly but without increased side-effects compared to the standard three step approach of the WHO analgesic ladder.
Secondary objective: to establish whether a two step approach to cancer pain relief has improved health economics compared to the standard three step approach of the WHO analgesic ladder.
Design
An open randomised parallel group trial comparing a two step approach for cancer pain relief with the standard three step approach of the WHO analgesic ladder in patients with cancer pain requiring step 2 analgesia (weak opioid).
Methods
The experimental intervention is a two step approach to analgesia where patients will immediately commence a strong opioid. The choice of strong opioid must be listed as an approved medication (morphine or oxycodone), while the initial dose and any increases will be determined by the local investigator with the rate of titration as per local practice.
The control intervention is the standard three step approach to analgesia where patients will commence a weak opioid first and if pain control is not achieved then they will commence a strong opioid. The choice of weak opioid must be listed as an approved medication (codeine ortramadol) and the maximum dose is standardised.
If the average pain score remains ≥4 (0-10 NRS), and in the opinion of the investigator meaningful pain improvement has not been achieved despite the maximum dose of weak opioid, then patients will commence a strong opioid. The choice of strong opioid must be listed as an approved medication while the initial dose and any increases will be determined by the local investigator with the rate of titration as per local practice.
The study will last for 20 days.
Data collection
Data will be recorded in case report forms. The registered data will consist of:
Demography (age, sex, race)
Performance status (Karnofsky)
Cancer characteristics (cancer type, metastases)
Average pain in last 24 hours
Worst pain in last 24 hours
Brief Pain Inventory
NCCN Distress Thermometer
Analgesic Use
Non-analgesic Medication
Opioid Toxicity and Side-effects Questionnaire
SF12
Status
A total of 153 patients have been recruited from 17 sites in Scotland, England, Israel,Mexico and Uganda. The study was closed for recruitment in March 2016, and analyses are ongoing.
Organisation
The TVT is coordinated by the University of Edinburgh, and the chief investigator is Marie Fallon,Professor, MD. Lucy Norris is the project manager.
Principal Investigators:
Barry Laird, MD, Glasgow, UK Stein Kaasa, Professor, MD, Trondheim, NO Augusto Caraceni, Professor, MD, Milan, IT Collette Reid, MD, Bristol, UK
ICBP is a unique and innovative global partnership of clinicians, academics and policymakers, and collaboration between Great Britain, Canada, Australia, Denmark, Sweden and Norway.
Aim:
to understand how and why cancer survival varies between countries/jurisdictions. NTNU, represented by the European Palliative Care Research Centre (PRC), participates in the partnership on behalf of the Norwegian Directorate of Health.
The ICBP work programme is looking specifically at four diagnoses: breast, colorectal, lung and ovarian cancer.
The ICBP works across 5 areas of research (modules). Each module looks at different aspects of cancer survival to identify possible reasons for differences between partners. The modules are as follows: 1. Epidemiology; 2. Population awareness and beliefs; 3. Beliefs, behaviours and systems in primary care; 4. Root cause of diagnosis and treatment delays; and 5. Analysis of short term mortality.
Module 1 has achieved one of its key aims: to produce a robust and comparable overview of cancer survival in the six diff erent ICBP countries. The first ICBP paper ‘Cancer survival in Australia, Canada, Denmark, Norway, Sweden and the UK, 1995-2007: the International Cancer Benchmarking Partnership’ was published by the medical journal Lancet online in December 2010 and in the print edition in January 2011. The paper compares survival from colorectal, lung, breast, and ovarian cancer in the six ICBP countries for patients diagnosed between 1995 and 2007. The results show that cancer survival has improved in all countries but that differences remain. Survival is higher in Australia, Canada, and Sweden, intermediate in Norway and lower in Denmark and the UK (England, Northern Ireland and Wales).
Module 2 of the International Cancer Benchmarking Partnership (ICBP) is exploring the attitudes and beliefs the general public has towards cancer. Module 2 has recently provided the first robust international comparison of population awareness and beliefs about cancer. The study suggested that international differences in cancer survival are not likely to be explained by differences in awareness and beliefs about cancer and cancer outcomes. The results showed that the public awareness of cancer symptoms and beliefs about cancer outcomes was similar internationally. All of the countries reported that around eight out of eleven cancer symptoms were recognized by members of the public. In all of the countries, people had positive beliefs about cancer with around nine out of ten people agreeing that ‘cancer can often be cured’ and seven out of ten disagreeing that ‘a diagnosis of cancer is a death sentence’.
The publication ‘Differences in cancer awareness and beliefs between Australia, Canada, Denmark,Norway, Sweden and the UK (the International Cancer Benchmarking Partnership): do they contribute to differences in cancer survival?’ you can find it on the British Journal of Cancer’s web page.
Module 3 was performed in Norway in spring 2013. This module looks specifically at the role of primary care in diagnosing cancer. A total of 232 Norwegian general practitioners responded on this web-based survey. The main result paper is currently under peer review and is expected to be published by summer 2015.
The work with Module 4 started up in 2013. Module 4 will provide the first robust international comparison of the time intervals from first symptom(s) until diagnosis and start of treatment of cancer patients. The aim of this module is to test the hypothesis that longer time intervals can contribute to poorer cancer outcomes. Data collection in Norway has been started since September 2014. In the 1st round of data collection, 1657 questionnaires were sent out to GPs,who will forward the questionnaires to patients involved. By February 2015, we have received 289 answers from invited patients. The response rates are 22% for breast cancer, 18% for colorectal cancer, 11% for lung cancer and 17% for ovarian cancer. In the 2nd round of data collection, 1792 questionnaires were sent out to GPs. By April 2015, we have now received 201 patient questionnaires. Data collection will approach to the end by summer 2015, and first publication is expected in 2016.
Module 5: The aim of this module is to examine the influence of co-morbidity on early death from lung cancer. The study population will consist of all individuals resident in Norway diagnosed with a first primary lung (ICD10 C33-32, excluding traches C33) in the study period. Data from 2009 until the most recent complete year of cancer registration will be requested so allowing 3-year survival to be assessed. PRC is in cooperation with Norwegian Cancer Registry for this project. Data collection from various national registries is ongoing, and we aim to have all data ready in late 2015. First publication is expected in 2016.
– A prospective, randomized, placebo controlled and double blind study
Corticosteroids are frequently used as adjuvant analgesics. The studies concerning corticosteroids and pain are small, show conflicting results, and have methodological deficiencies. We therefore wanted to perform a multicenter study designed to assess the analgesic properties of a commonly used dose of corticosteroid, Methylprednisolone 16 mg two times daily, for cancer pain in palliative patients.
The primary aim of this study was to evaluate the immediate analgesic effects of corticosteroids administrated for 7 days in palliative cancer patients with pain, and evaluate the tolerance of this medication.
The participants were patients with advanced cancer treated with opioids, and they were recruited from five palliative care units in Norway (n=47).
