Early palliative care consultation for people with bone metastases referred for radiotherapy
Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial (TIPZO-RT Trial)
This trial will test if offering an early hospital palliative care consultation improves quality of life and satisfaction for adults with advanced cancer and bone metastases who are referred for palliative radiotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 5 sites (Amersfoort and 4 other locations) |
| Trial ID | NCT06805396 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 2 trial offers patients referred for palliative radiotherapy for bone metastases a consultation with the hospital palliative care consultation team (PCCT) versus usual care. Participants are enrolled at participating Dutch centers and provide broad consent for regular questionnaires (PRESENT+) and randomization. The primary outcomes are patient-reported satisfaction with care and quality of life measured over time. Key exclusions are inability to understand Dutch, cognitive impairment, or prior contact with the hospital PCCT.
Who should consider this trial
Good fit: Adults with advanced cancer and bone metastases referred for palliative radiotherapy at a participating Dutch center who can understand Dutch and have given broad consent for questionnaires are ideal candidates.
Not a fit: Patients who cannot understand Dutch, have cognitive impairment, have already had contact with hospital palliative care consultants, or are treated outside the participating centers are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, timely palliative care consultations could reduce symptom burden, improve quality of life, and increase patient satisfaction with care.
How similar studies have performed: Other randomized oncology trials of early specialist palliative care have shown reduced symptom burden and improved quality of life, but randomized data specifically for patients referred for palliative radiotherapy to bone are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Amersfoort and 4 other locations
- Meander MC — Amersfoort, Netherlands (Recruiting)
- Groene Hart Ziekenhuis — Gouda, Netherlands (Recruiting)
- Alrijne Ziekenhuis — Leiden, Netherlands (Recruiting)
- Lumc — Leiden, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Yvette M. van der Linden — Leiden University Medical Center
- Study coordinator: Roxanne Gal, PhD
- Email: R.Gal@umcutrecht.nl
- Phone: +31887555555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.