Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases in Subjects With Advanced Cancer | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative Care Consult | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Palliative care consultation
- description
- Timely referral to the palliative care consult team.
- interventionNames
- Behavioral: Palliative Care Consult
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients will not be informed about the trial and will receive standard of care.
Primary outcomes (1)
- measure
- Satisfaction with care
- timeFrame
- 4 weeks after the start of radiotherapy
- description
- Satisfaction with care is measured by the EORTC PATSAT-C33 - Affective behavior scale. The 33-item questionnaire includes three sections addressing the perceived quality of care provided by doctors, nurses/radiotherapy technicians, and service/care organization. Participants are asked to rate their experience for each item on a five-point Likert scale (poor to excellent). For this study, we use the 4-item affective behavior scale from the "nurses and radiotherapy technicians" section. Instead of rating "nurses and radiotherapy technicians", we ask the participants to rate the care from "healthcare providers" in the hospital to broadly assess patient satisfaction.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. broad informed consent for PRESENT+ (i.e., consent for filling out questionnaires at regular intervals and randomization into future intervention studies), and 2. having their treating physician in the TIPZO-RT study site (UMC Utrecht, Radboudumc or LUMC). Exclusion Criteria: 1. not able to understand the objective of the study (in Dutch), 2. cognitive impairment or dementia, and 3. has been in contact with palliative care consultants of the hospital PCCT before.
References
Publications (1)
- DERIVEDvan Oss A, van der Velden JM, Verkooijen HM, van Jaarsveld R, Hesselmann GM, Kuip EJM, Westhoff PG, Raijmakers NJH, van der Linden YM, Gal R. 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. PLoS One. 2026 May 22;21(5):e0349792. doi: 10.1371/journal.pone.0349792. eCollection 2026. PMID 42172282