Actively Recruiting
Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial
Led by Roxanne Gal · Updated on 2026-05-12
246
Participants Needed
5
Research Sites
86 weeks
Total Duration
On this page
Sponsors
R
Roxanne Gal
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Rationale: With improvements in systemic tumour-directed treatments for primary tumours, survival rates for patients with bone metastases are improving. However, individual illness trajectories become less predictable and more vulnerable to adverse events from treatments, negatively impacting a patient's quality of life (QoL). Palliative care is aimed at reducing symptoms and improving QoL for patients with incurable diseases through early identification, thorough assessment, and effective management of physical, psychological, social, and spiritual challenges. Early integration of specialist palliative care into oncology care has shown to reduce symptom burden and potentially inappropriate end-of-life care, and to enhance QoL, yet it is often initiated late. Objective: The primary objective is to evaluate the satisfaction with care and QoL experienced by patients with bone metastases who are offered a consultation with the hospital palliative care consultation team (PCCT) when referred for palliative radiotherapy compared to patients who receive standard of care. Study design: A prospective, pragmatic, two-arm multicenter randomized controlled trial within the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT+) cohort that follows the Trials within Cohorts (TwiCs) design. Study population: Patients with bone metastases referred for palliative radiotherapy who have their treating physician in one of the participating centers and have not been in contact with the hospital PCCT before. Intervention: A consultation with the hospital PCCT within two weeks after inclusion in PRESENT+. In the standard of care control group, no consultation with the PCCT will be scheduled. They may have a consultation during follow-up if referring physicians may consider a consultation appropriate, or when patients themselves feel they want a referral. Main study parameters/endpoints: Satisfaction with care (affective behavior) four weeks after inclusion in PRESENT+.
CONDITIONS
Official Title
Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided broad informed consent for the PRESENT+ study including questionnaires and randomization
- Have a treating physician at one of the study sites: UMC Utrecht, Radboudumc, or LUMC
You will not qualify if you...
- Unable to understand the study objective in Dutch
- Have cognitive impairment or dementia
- Have had previous contact with the hospital palliative care consultation team
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Meander MC
Amersfoort, Netherlands
Actively Recruiting
2
Groene Hart Ziekenhuis
Gouda, Netherlands
Actively Recruiting
3
Alrijne Ziekenhuis
Leiden, Netherlands
Actively Recruiting
4
LUMC
Leiden, Netherlands
Actively Recruiting
5
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
Research Team
R
Roxanne Gal, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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