Palliative Care Yields Cancer Wellbeing Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A transitional palliative care intervention.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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 co
Primary outcome measures
- The difference in number of readmissions into hospital between the patients in the intervention arm and controle arm [Time frame: 90 days after the end of the study or after death.]
Secondary outcome measures (11)
- Demographic characteristics relative [Time frame: 14 days after baseline.]
- European Organization for Research and Treatment for Cancer Quality of Life Questionnaire C30 [Time frame: Baseline, 30 days and 90 days after baseline.]
- The Functional Assessment of Cancer Therapy - General (FACT-G) [Time frame: Baseline, 30 days and 90 days after baseline.]
- The Consultation and Rational Empathy measure (The CARE measure) [Time frame: 14 days after baseline]
- Caregiver Network Analysis [Time frame: 30 days after baseline]
- FAMCARE [Time frame: 14 days after baseline]
- Place and date of death [Time frame: 90 days after the end of the study or after death.]
- Presence of Advance decisions to refuse treatment (ADRTs) and Advance care plans (ACPs) as referred to in the hospital medical records. [Time frame: 90 days after the end of the study or after death.]
- Referrals to palliative care services [Time frame: 90 days after the end of the study or after death.]
- Economic analysis to assess the consequences of the intervention on health outcomes and resource utilization [Time frame: 90 days after the end of the study or after death.]
- Demographic characteristics patients [Time frame: Baseline.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Netherlands · 1 center
- Radboudumc — Nijmegen
Publications
- Hooley R, Payne S, Brunsch H, Surges SM, Mosoiu D, Hurducas F, Hernandez-Marrero P, Pereira SM, Csikos A, Pozsgai E, Leppert W, Forycka-Ast M, van den Brand P, Hasselaar J, Preston N. Adapting a palliative care intervention for people with advanced cancer across seven European countries: the Pal-Cycles intervention. BMC Palliat Care. 2026 Jun 12;25(1):181. doi: 10.1186/s12904-026-02105-0. PMID 42332712
Identifiers
NCT: NCT06259136 · 101057243