Advanced Incurable CancerIZERZONCT03237884
Romanian-Swiss Research Programme IZERZO
An observational study of Advanced Incurable Cancer, run by Cantonal Hospital of St. Gallen at 2 sites in 2 countries.
Trial summary
Palliative Care procedures should be integrated early in the course of disease of patients with advanced incurable cancer. With this study, where the investigators follow adult patients with incurable cancer over 6 months or until death (whatever occurs earlier), the investigators aim to identify patients' needs for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Incurable Cancer
- How many people
- 308 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2013to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced, incurable cancer patients, adult, without cognitive impairment, with a minimal symptom burden (defined threshold on IPOS)
Who may be able to join
- stage IV cancer
- over 18 years
- minimal symptom burden in IPOS (at least 3 symptoms over or equal 2)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 1, 2, 3
Who cannot join
- cognitively impaired
- prognosis less than 1 month according to clinician
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Reality Map of Integrated Oncology and Palliative Care in Romanian and Swiss Cancer Centres
Palliative Care procedures should be integrated early in the course of disease of patients with advanced incurable cancer. With this study, where the investigators follow adult patients with incurable cancer over 6 months or until death (whatever occurs earlier), the investigators aim to identify patients' needs for Palliative Care interventions (like support in illness understanding and decision making, symptom management, concrete end-of-life preparation, and others) and their remembered delivery by health care professionals. The investigators also collect data on patients care (use of chemotherapy, intensive care in the last month of life) and quality of death and dying (assessed by post-death-interviews with bereaved relatives). The aim is to have a "reality map" on current integration of oncology and palliative care and to test if appropriate Palliative Care interventions predict a better outcome.
Read the detailed description
Background The integration of Palliative Care (PC) in routine oncological care remains challenging, particularly in resource-restricted, culturally diverse, and regulatory/legal disperse settings like Romania. The investigators aim to collect original data ("reality map") about the implementation of Key-Interventions Palliative-Cancer-Care (KI-PCC) and specific outcome quality indicators (QI). The investigators also hypothesize that both predefined cofactors and appropriately delivered KI-PCC will predict quality of care.
Aim The aim is to detect gaps in the care of advanced incurable cancer patients. Because in this setting there are no predefined structures, the investigators focus on interventions perceived by the patient.
Methods The investigators' target population are advanced incurable cancer patients in different care settings (oncology clinics, Palliative Care centers, and hospice, varying in size, location (rural, urban) and grade of specialization) representing the heterogeneity of care in Romania. The investigators characterize the population using demographic data (EAPC basic dataset amended by country specific data like family structures and income), and validated tools for patient needs (IPOS, EQ5D). Need for and perceived Key interventions of Palliative Cancer Care (KI-PCC), measured by nurse-patient-interaction, are assessed. These KI-PCC include illness understanding, symptom management, decision making, spirituality, end-of-life-preparation, and network/family support. Further, the investigators collect defined outcome quality indicators (QI) for the integration (quality of death and dying, symptoms, aggressive end-of-life-care, inappropriate anticancer care, ER-visits). In addition, known, associated cofactors (e.g. comorbidities, living situation) are measured. The data collection will be longitudinal with monthly follow-ups for at most six months or until death. Focus groups at each participating center explore local influencing factors both for KI-PCC and QI. Several steps of quality assurance (source data verification, expert reviews of anticancer treatment, etc.) are introduced.
The analysis has three elements. First, the investigators will describe the population. Second, the investigators will map the patient perceived KI-PCC and defined outcome QI. Third, if data show robust after international expert review, the investigators will test the hypothesis that appropriate KI-PCC predict quality of care, measured by QI.
Expected impact The investigators expect that their approach will identify gaps in the integration of oncology and palliative care in their specific settings, focusing, however, mainly on patient and proxy view and backed by available information from outcome QI. The conduct of this protocol might also directly have an influence on patient care.
This approach will allow the development of tailored interventions in a next step. The investigators' approach may also serve as a model to measure the integration of oncology and palliative care in various settings, focusing on interventions.
- Conditions
- Advanced Incurable Cancer
- Keywords
- Palliative Care, Oncology, advanced incurable cancer (any type), integration, development, palliative care interventions, process indicators, Romania
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
A composite endpoint, composed by the outcome indicators inappropriate anticancer care, repeated ER-admissions, high symptom burden (on IPOS), "aggressive" end-of-life-care, and bad quality of death and dying (QODD)
Measured: up to 6 months (or death, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Jan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Incurable CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian Strasser, MD ABHPM, Cantonal Hospital of St. Gallen
- Investigators
- Florian Strasser, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237884
- Sponsor's protocol ID
- EKSG 13/157
- Other IDs
- IZERZO_142226/1
- Acronym
- IZERZO
- Status last verified
- Jul 2017
- First submitted
- 25 Jun 2014
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reality Map of Integrated Oncology and Palliative Care in Romanian and Swiss Cancer Centres
- ClinicalTrials.gov ID
- NCT03237884
- Acronym / sponsor ID
- IZERZO / EKSG 13/157
- Conditions
- Advanced Incurable Cancer
- Keywords
- Palliative Care, Oncology, advanced incurable cancer (any type), integration, development, palliative care interventions, process indicators, Romania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palliative Care procedures should be integrated early in the course of disease of patients with advanced incurable cancer. With this study, where the investigators follow adult patients with incurable cancer over 6 months or until death (whatever occurs earlier), the investigators aim to identify patients' needs for Palliative Care interventions (like support in illness understanding and decision making, symptom management, concrete end-of-life preparation, and others) and their remembered delivery by health care professionals. The investigators also collect data on patients care (use of chemotherapy, intensive care in the last month of life) and quality of death and dying (assessed by post-death-interviews with bereaved relatives). The aim is to have a "reality map" on current integration of oncology and palliative care and to test if appropriate Palliative Care interventions predict a better outcome.
Detailed description
Background The integration of Palliative Care (PC) in routine oncological care remains challenging, particularly in resource-restricted, culturally diverse, and regulatory/legal disperse settings like Romania. The investigators aim to collect original data ("reality map") about the implementation of Key-Interventions Palliative-Cancer-Care (KI-PCC) and specific outcome quality indicators (QI). The investigators also hypothesize that both predefined cofactors and appropriately delivered KI-PCC will predict quality of care.
Aim The aim is to detect gaps in the care of advanced incurable cancer patients. Because in this setting there are no predefined structures, the investigators focus on interventions perceived by the patient.
Methods The investigators' target population are advanced incurable cancer patients in different care settings (oncology clinics, Palliative Care centers, and hospice, varying in size, location (rural, urban) and grade of specialization) representing the heterogeneity of care in Romania. The investigators characterize the population using demographic data (EAPC basic dataset amended by country specific data like family structures and income), and validated tools for patient needs (IPOS, EQ5D). Need for and perceived Key interventions of Palliative Cancer Care (KI-PCC), measured by nurse-patient-interaction, are assessed. These KI-PCC include illness understanding, symptom management, decision making, spirituality, end-of-life-preparation, and network/family support. Further, the investigators collect defined outcome quality indicators (QI) for the integration (quality of death and dying, symptoms, aggressive end-of-life-care, inappropriate anticancer care, ER-visits). In addition, known, associated cofactors (e.g. comorbidities, living situation) are measured. The data collection will be longitudinal with monthly follow-ups for at most six months or until death. Focus groups at each participating center explore local influencing factors both for KI-PCC and QI. Several steps of quality assurance (source data verification, expert reviews of anticancer treatment, etc.) are introduced.
The analysis has three elements. First, the investigators will describe the population. Second, the investigators will map the patient perceived KI-PCC and defined outcome QI. Third, if data show robust after international expert review, the investigators will test the hypothesis that appropriate KI-PCC predict quality of care, measured by QI.
Expected impact The investigators expect that their approach will identify gaps in the integration of oncology and palliative care in their specific settings, focusing, however, mainly on patient and proxy view and backed by available information from outcome QI. The conduct of this protocol might also directly have an influence on patient care.
This approach will allow the development of tailored interventions in a next step. The investigators' approach may also serve as a model to measure the integration of oncology and palliative care in various settings, focusing on interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced, incurable cancer patients, adult, without cognitive impairment, with a minimal symptom burden (defined threshold on IPOS)
Key inclusion criteria (4 listed)
- stage IV cancer
- over 18 years
- minimal symptom burden in IPOS (at least 3 symptoms over or equal 2)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 1, 2, 3
Key exclusion criteria (2 listed)
- cognitively impaired
- prognosis less than 1 month according to clinician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite Endpoint
Time frame: up to 6 months (or death, whichever occurs first)
A composite endpoint, composed by the outcome indicators inappropriate anticancer care, repeated ER-admissions, high symptom burden (on IPOS), "aggressive" end-of-life-care, and bad quality of death and dying (QODD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Strasser, MD principal investigator
Cantonal Hospital of St. Gallen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Incurable Cancer, run by Cantonal Hospital of St. Gallen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint (time frame: up to 6 months (or death, whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.