Actively Recruiting

Phase 2
All Genders
NCT06805396

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial | DecenTrialz