Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1050 participants
INTERVENTIONAL
2024-06-01
2027-08-31
Brief Summary
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The main hypothesis for the study is: that fewer people in the intervention arm of the study will require hospital re admission than those having usual care.
Participants will be asked to fill in questionnaires regarding their quality of care and quality of life.
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Detailed Description
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The goals of the overarching research project are as follows:
1. To develop, implement and evaluate a transitional palliative cancer care intervention, with an intervention (the Pal-Cycles intervention) that aims for a smooth transition from the hospital to community-based care in the final months of life.
2. Adaptation of the transitional palliative cancer care intervention for patients with advanced cancer for its implementation in seven European countries within the project.
3. Training of oncologists in identifying patients with palliative care needs, establishing collaboratively comprehensive treatment and care plans, delivering patient-centred communication around discharge planning, advance care planning, and end-of-life care.
4. A clinical trial using a stepped wedge design will be implemented in fourteen care settingsacross seven European countries.
5. An implementation support intervention will guide the implementation of the clinical trial in all settings and will investigate barriers and opportunities for implementation and provide tailormade solutions where needed.
6. Dissemination of project results.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
The design will start by an initial period in which all clusters e.g. different hospital sites, are part of the control group in which the patients receive care as usual. Subsequently, groups of clusters are exposed to the intervention at regular intervals (steps) until all clusters patients in all clusters have received care as defined in the intervention. The decision about which group of clusters will receive the intervention at which point in time is decided by randomization
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Pal-Cycles Intervention
The patients in the intervention arm will be exposed to the Pal-Cycles intervention.
A transitional palliative care intervention
The Pal-Cycles intervention starts just before the care transition from curative oncology care to palliative care with a goals of care conversation between a hospital care provider and the patient. The conversation will be recorded in a summary of treatment and care form which will be completed by a hospital based clinician based on the key elements of the conversation with the patient and the treatment and care plan. Afterwards a (digital) copy of the form is given to the patient and another copy is sent to the general practitioner in combination with the discharge letter.
Care as usual
The patients included in this intervention will be given care as usual.
No interventions assigned to this group
Interventions
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A transitional palliative care intervention
The Pal-Cycles intervention starts just before the care transition from curative oncology care to palliative care with a goals of care conversation between a hospital care provider and the patient. The conversation will be recorded in a summary of treatment and care form which will be completed by a hospital based clinician based on the key elements of the conversation with the patient and the treatment and care plan. Afterwards a (digital) copy of the form is given to the patient and another copy is sent to the general practitioner in combination with the discharge letter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with advanced cancer
* Patients that are expected to develop or already may have palliative care needs
* Patients who are in transition from curative (hospital) to palliative care (community care)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Lancaster University
OTHER
University Hospital, Bonn
OTHER
University of Navarra
OTHER
University in Zielona Góra
OTHER
University of Pecs
OTHER
European Association for Palliative Care (EAPC)
UNKNOWN
Universidade Católica Portuguesa
OTHER
Hospice Villa Speranza
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeroen Hasselaar
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center (Radboudumc)
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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101057243
Identifier Type: -
Identifier Source: org_study_id
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