NCT06805396

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

Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: a Randomized Trial (TIPZO-RT Trial)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Roxanne Gal · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

• Bone Metastases in Subjects with Advanced Cancer
• Radiotherapy

Interventions

Type	Name	Description
BEHAVIORAL	Palliative Care Consult	Patients receive a regular consult (30-45 min) with the hospital palliative care consult team (PCCT) that is tailored to the preferences and needs of the individual patient. The following topics can be discussed: 1) physical symptoms, and, where appropriate, followed by recommendations for symptom management and transfer of handovers to the treating care team, 2) psychological, social and spiritual distress, followed by provision of counseling or referral to another specialist if needed, 3) goals of care to explore participants' values, preferences and needs (advance care planning), and 4) discussion about the needed follow-up of palliative care, and 5) care for caregivers. At baseline, patients receive a validated symptom questionnaire (Utrecht Symptom Diary (USD)-4D), which can be used as input for discussion during the consultation. If necessary, patients may have a follow up.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-08-31
• Completion: 2026-09-30
• First posted: 2025-02-03
• Last updated: 2025-03-26