NCT06805396RecruitingPhase 2
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 · Last updated 12 May 2026
Brief summary (registry, in English)
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+.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- First submitted
- 20 Jan 2025
- Start date
- 2 Jun 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Roxanne Gal
- Diseases
- Childhood cancers
- NCT number
- NCT06805396
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 246
- From 2 Jun 2025 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- cognitive impairment or dementia, and
Other
- not able to understand the objective of the study (in Dutch),
- has been in contact with palliative care consultants of the hospital PCCT before.
Who the study is looking for
- broad informed consent for PRESENT+ (i.e., consent for filling out questionnaires at regular intervals and randomization into future intervention studies), and
- having their treating physician in the TIPZO-RT study site (UMC Utrecht, Radboudumc or LUMC).
Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meander MC Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Recruiting |
| Groene Hart Ziekenhuis Coordinator of this site? Confirm its status | Gouda | Netherlands | Recruiting |
| Alrijne Ziekenhuis Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| LUMC Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.