Palliative Care Yields Cancer Wellbeing Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,050
- Locations
- 2
- Primary Endpoint
- The difference in number of readmissions into hospital between the patients in the intervention arm and controle arm
Study Overview
Brief 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:
- 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.
- Adaptation of the transitional palliative cancer care intervention for patients with advanced cancer for its implementation in seven European countries within the project.
- 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.
- A clinical trial using a stepped wedge design will be implemented in fourteen care settingsacross seven European countries.
- 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.
- Dissemination of project results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Care as usual
The patients included in this intervention will be given care as usual.
Pal-Cycles Intervention
The patients in the intervention arm will be exposed to the Pal-Cycles intervention.
Intervention: A transitional palliative care intervention (Procedure)
Outcomes
Primary Outcomes
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.
The primary outcome of this research project will be the difference between the readmission rate from the control group and the intervention group. This was chosen based on the presumption that if the communication between healthcare professionals improves, the transition to home will be better and patients will be less likely to require hospital care. Another advantage is that it is a feasible and often well documented outcome measure which can be retrieved across multiple sites in multiple countries. A second advantage especially relevant for studies concerned with palliative care patients is that it can be measured early, as many patients die (of unrelated causes) during the study. By measuring early measurement compliance can be ensured.
Secondary Outcomes
- The Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline, 30 days and 90 days after baseline.)
- Place and date of death(90 days after the end of the study or after death.)
- Caregiver Network Analysis(30 days after baseline)
- Demographic characteristics patients(Baseline.)
- The Consultation and Rational Empathy measure (The CARE measure)(14 days after baseline)
- Referrals to palliative care services(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(90 days after the end of the study or after death.)
- Demographic characteristics relative(14 days after baseline.)
- European Organization for Research and Treatment for Cancer Quality of Life Questionnaire C30(Baseline, 30 days and 90 days after baseline.)
- FAMCARE(14 days after baseline)
- Presence of Advance decisions to refuse treatment (ADRTs) and Advance care plans (ACPs) as referred to in the hospital medical records.(90 days after the end of the study or after death.)