NCT06805396: TIPZO-RT

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

Not yet recruiting Phase 2 Last updated 26 March 2025

What this trial tests

Phase 2 trial testing Palliative Care Consult in Bone Metastases in Subjects with Advanced Cancer in 246 participants. Not yet recruiting.

Timeline

1 April 2025

Primary endpoint
31 August 2026

30 September 2026

Quick facts

Lead sponsor	Roxanne Gal
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	246
Start date	1 April 2025
Primary completion	31 August 2026
Estimated completion	30 September 2026

Drugs / interventions tested

• Palliative Care Consult

Conditions studied

• Bone Metastases in Subjects with Advanced Cancer — all drugs for Bone Metastases in Subjects with Advanced Cancer →
• Radiotherapy — all drugs for Radiotherapy →

Sponsor

Roxanne Gal

Who can join

Eligibility, any sex, with Bone Metastases in Subjects with Advanced Cancer or Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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+.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Timely Integration of specialist palliative care into oncology care for patients receiving radiotherapy for bone metastases: A study procotol for the TIPZO-RT Randomized Controlled Trial.
   van Oss A, van der Velden JM, Verkooijen HM, van Jaarsveld R, et al · · 2026 · PMID 42172282 · DOI 10.1371/journal.pone.0349792