Palliative Care Yields Cancer Wellbeing Support

NCT06259136 | Recruiting

• 1 other identifier: 101057243
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Palliative care; Transitional care; End of life care

Outcome Measures

Primary Outcomes (1)

• The difference in number of readmissions into hospital between the patients in the intervention arm and controle arm

  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.

  90 days after the end of the study or after death.

Secondary Outcomes (11)

• 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.

• The Functional Assessment of Cancer Therapy - General (FACT-G)

  Baseline, 30 days and 90 days after baseline.

• The Consultation and Rational Empathy measure (The CARE measure)

  14 days after baseline

• Caregiver Network Analysis

  30 days after baseline

Study Arms (2)

Pal-Cycles Intervention

EXPERIMENTAL

The patients in the intervention arm will be exposed to the Pal-Cycles intervention.

Procedure: A transitional palliative care intervention

Care as usual

NO INTERVENTION

The patients included in this intervention will be given care as usual.

Interventions

A transitional palliative care intervention PROCEDURE

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.

Also known as: Pal-Cycles intervention

Pal-Cycles Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• People with cancer unable or unwilling to provide consent to participate in the study

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Lancaster University: collaborator
• University Hospital, Bonn: collaborator
• University of Navarra: collaborator
• University in Zielona Góra: collaborator
• University of Pecs: collaborator
• European Association for Palliative Care (EAPC): collaborator
• Universidade Católica Portuguesa: collaborator
• Hospice Villa Speranza: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeroen Hasselaar

  Radboud University Medical Center (Radboudumc)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pippa van den Brand, MSC

CONTACT

024 361 1111; pippa.vandenbrand@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be made available one year after the end of the study (2028) and will be available for 15 years.
• Access Criteria: If applicants would like access to the datafiles they will need to ask permission from the access committee formed by Radboudumc and the principal investigator. This committee will weigh each request on its objectives. Requests will be sent to a mailbox of the Radboudumc, to guarantee accessibility with the then appointed employees.

Locations

NL (1)