Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palliative Care Consult.
- Who it may be relevant to
- Registry conditions: Bone Metastases in Subjects With Advanced Cancer, Radiotherapy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial (TIPZO-RT Trial)
Overview
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+.
Interventions
- 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) goal
Primary outcome measures
- Satisfaction with care [Time frame: 4 weeks after the start of radiotherapy]
Secondary outcome measures (8)
- Symptom burden [Time frame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks]
- Pain [Time frame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks]
- Quality of Life [Time frame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months]
- Other satisfaction with care outcomes [Time frame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months]
- Overall survival [Time frame: Max. two years]
- Palliative care utilization [Time frame: Through study completion, about 2 years]
- Palliative care utilization [Time frame: Through study completion]
- Palliative care utilization [Time frame: Up to two years]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- not able to understand the objective of the study (in Dutch),
- cognitive impairment or dementia, and
- has been in contact with palliative care consultants of the hospital PCCT before.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Netherlands · 5 centers
- Meander MC — Amersfoort
- Groene Hart Ziekenhuis — Gouda
- Alrijne Ziekenhuis — Leiden
- LUMC — Leiden
- Radboudumc — Nijmegen
Publications
- van 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.034979 PMID 42172282
Identifiers
NCT: NCT06805396 · 25U-0028