Palliative Care Yields Cancer Wellbeing Support (Pal-Cycles): Evaluating a Transitional Palliative Care Intervention to Reduce Readmissions for Patients with Advanced Cancer and palliative care needs — An International Stepped-Wedge Randomized Clinical Trial Protocol

Background Palliative care in combination with or after oncological treatment has been found to increase the quality of life and quality of care for patients with advanced cancer. This often means change in goals of care, sometimes along with a change of healthcare provider or place of care. These types of changes are frequently referred to as care transitions. Ensuring continuity of care during these types of transitions is crucial, yet previous research has shown that essential information is not always effectively communicated. Sometimes, this leads to avoidable hospital readmissions, which may cause distress and decreases the quality of life for patients in the last phase of life. This study aims to evaluate the effectiveness of a transitional palliative care intervention in reducing hospital readmissions. Methods This study will employ a stepped wedge cluster randomized controlled trial (RCT) design conducted across 14 settings in seven European countries. (Germany, Hungary, the Netherlands, Poland, Portugal, Romania and the United Kingdom). Over a 25 months recruitment-period, 1,050 patients with advanced cancer and if possible, a relative will be enrolled. Patients will be followed for 90 days after inclusion. The primary outcome is the number of hospital readmissions, with secondary outcomes being quality of life and quality of care. Once data collection is complete, a multilevel regression analysis will compare outcomes between the control and intervention groups within each setting, accounting for the hierarchical structure of the data. Discussion The study results will determine the effectiveness of the Pal-Cycles intervention in decreasing the number of readmissions to hospital, and increasing the quality of life and the quality of care for patients with advanced cancer. Trial Registration number: ClinicalTrials.gov ID: NCT06259136, 2025-07-28, Study Details | NCT06259136 | Palliative Care Yields Cancer Wellbeing Support | ClinicalTrials.gov