Clinical trial NCT06259136: Palliative Care Yields Cancer Wellbeing Support
Official title: Palliative Care Yields Cancer Wellbeing Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Palliative care
Transitional care
End of life care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Lancaster University
name: University Hospital, Bonn
name: University of Navarra
name: University in Zielona Góra
name: University of Pecs
name: European Association for Palliative Care (EAPC)
name: Universidade Católica Portuguesa
name: Hospice Villa Speranza
First posted: 2024-02-14
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: For this study a cross-sectional stepped wedge clustered clinical trial will be conducted.

The design will start by an initial period in which all clusters e.g. different hospital sites, are part of the control group in which the patients receive care as usual. Subsequently, groups of clusters are exposed to the intervention at regular intervals (steps) until all clusters patients in all clusters have received care as defined in the intervention. The decision about which group of clusters will receive the intervention at which point in time is decided by randomization
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: The difference in number of readmissions into hospital between the patients in the intervention arm and controle arm
timeFrame: 90 days after the end of the study or after death.
Secondary outcomes:
measure: Demographic characteristics relative
timeFrame: 14 days after baseline.
measure: European Organization for Research and Treatment for Cancer Quality of Life Questionnaire C30
timeFrame: Baseline, 30 days and 90 days after baseline.
measure: The Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Baseline, 30 days and 90 days after baseline.
measure: The Consultation and Rational Empathy measure (The CARE measure)
timeFrame: 14 days after baseline
measure: Caregiver Network Analysis
timeFrame: 30 days after baseline
measure: FAMCARE
timeFrame: 14 days after baseline
measure: Place and date of death
timeFrame: 90 days after the end of the study or after death.
measure: Presence of Advance decisions to refuse treatment (ADRTs) and Advance care plans (ACPs) as referred to in the hospital medical records.
timeFrame: 90 days after the end of the study or after death.
measure: Referrals to palliative care services
timeFrame: 90 days after the end of the study or after death.
measure: Economic analysis to assess the consequences of the intervention on health outcomes and resource utilization
timeFrame: 90 days after the end of the study or after death.
measure: Demographic characteristics patients
timeFrame: Baseline.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center (Radboudumc)
name: Jeroen Hasselaar
role: PRINCIPAL_INVESTIGATOR
References: