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Trial Title:
Palliative Care Yields Cancer Wellbeing Support
NCT ID:
NCT06259136
Condition:
Cancer
Conditions: Keywords:
Palliative care
Transitional care
End of life care
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
For this study a cross-sectional stepped wedge clustered clinical trial will be
conducted.
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
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
A transitional palliative care intervention
Description:
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.
Arm group label:
Pal-Cycles Intervention
Other name:
Pal-Cycles intervention
Summary:
The goal of this study is to evaluate the effectiveness of a programme for transitional
palliative cancer care (Pal-Cycles) in seven countries (the Netherlands, Germany, United
Kingdom, Hungary, Poland, Romania and Portugal) and its consequent effects on the number
of readmissions into hospital.
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.
Detailed description:
The study described in this protocol, a stepped wedge clinical trial, is part of a larger
research project named: The Palliative Care Yields Cancer Wellbeing Support Programme
(Pal-Cycles). The aim is to test and evaluate the implementation of the Pal-Cycles
intervention, by implementing it in 14 care setting across seven European countries (the
Netherlands, Germany, United Kingdom, Poland, Hungary, Romania and Portugal.) The primary
focus of the evaluation will be on measuring the effect of the Pal Cycles intervention
using the number of patients being readmitted into hospital after they had transferred to
community care in comparison with patients receiving usual care. Additional relevant
outcomes will also be gathered and analysed such as: the patient's quality of life, the
experience from the family carer and the experience from the healthcare professional.
Finally, an economic analysis will be embedded in the stepped wedge design.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged 18 years or above
- 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:
- People with cancer unable or unwilling to provide consent to participate in the
study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525GA
Country:
Netherlands
Contact:
Last name:
Pippa J. van den Brand, Msc
Phone:
+31 0643478851
Email:
pippa.vandenbrand@radboudumc.nl
Contact backup:
Last name:
Ian Koper, PhD
Email:
ian.koper@radboudumc.nl
Start date:
March 2024
Completion date:
August 2027
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Lancaster University
Agency class:
Other
Collaborator:
Agency:
University Hospital, Bonn
Agency class:
Other
Collaborator:
Agency:
University of Navarra
Agency class:
Other
Collaborator:
Agency:
University in Zielona Góra
Agency class:
Other
Collaborator:
Agency:
University of Pecs
Agency class:
Other
Collaborator:
Agency:
European Association for Palliative Care (EAPC)
Agency class:
Other
Collaborator:
Agency:
Universidade Católica Portuguesa
Agency class:
Other
Collaborator:
Agency:
Hospice Villa Speranza
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06259136
