Palliative Care Yields Cancer Wellbeing Support

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.

• Demographic characteristics relative [Срок оценки: 14 days after baseline.]
• European Organization for Research and Treatment for Cancer Quality of Life Questionnaire C30 [Срок оценки: Baseline, 30 days and 90 days after baseline.]
• The Functional Assessment of Cancer Therapy - General (FACT-G) [Срок оценки: Baseline, 30 days and 90 days after baseline.]
• The Consultation and Rational Empathy measure (The CARE measure) [Срок оценки: 14 days after baseline]
• Caregiver Network Analysis [Срок оценки: 30 days after baseline]
• FAMCARE [Срок оценки: 14 days after baseline]
• Place and date of death [Срок оценки: 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. [Срок оценки: 90 days after the end of the study or after death.]
• Referrals to palliative care services [Срок оценки: 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 [Срок оценки: 90 days after the end of the study or after death.]
• Demographic characteristics patients [Срок оценки: Baseline.]