NCT06259136

Palliative Care Yields Cancer Wellbeing Support

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,050 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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 copy is sent to the general practitioner in combination with the discharge letter.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-10-01
• Completion: 2027-08-01
• First posted: 2024-02-14
• Last updated: 2025-07-28

Locations

1 site across 1 country: Netherlands