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Bone Metastases in Subjects With Advanced CancerPhase 2TIPZO-RTNCT06805396

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

A Phase 2 study testing Palliative Care Consult in people with Bone Metastases in Subjects With Advanced Cancer and Radiotherapy, run by Roxanne Gal at 5 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
What is being tested?
Palliative Care Consult
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
5 sitesNetherlands
Study dates
2 Jun 2025to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Roxanne Gal, PhD contact

+31887555555

R.Gal@umcutrecht.nl

5 sites in 1 country

Netherlands5 sites, 5 recruiting

  • Meander MC

    Amersfoort

    Roxanne Gal, 00-00000000, r.gal@umcutrecht.nl

    Recruiting

  • Groene Hart Ziekenhuis

    Gouda

    Anouk van Oss, 00-00000000, a.van_oss@lumc.nl

    Recruiting

  • Alrijne Ziekenhuis

    Leiden

    Anouk van Oss, 00-00000000, a.van_oss@lumc.nl

    Recruiting

  • LUMC

    Leiden

    Anouk van Oss, 00-00000000, a.van_oss@lumc.nl

    Recruiting

  • Radboudumc

    Nijmegen

    Anouk van Oss, 00-00000000, a.van_oss@lumc.nl

    Recruiting

Other trials in Netherlands

About this study

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)

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.

Read more

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+.

Being tested
Palliative Care Consult
Keywords
Palliative Care, Bone Metastases, Radiotherapy, Advanced Cancer, Quality of Life, Quality of Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palliative Care ConsultBehavioural

    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) goals of care to explore participants' values, preferences and needs (advance care planning), and 4) discussion about the needed follow-up of palliative care, and 5) care for caregivers. At baseline, patients receive a validated symptom questionnaire (Utrecht Symptom Diary (USD)-4D), which can be used as input for discussion during the consultation. If necessary, patients may have a follow up.

Study groups in NCT06805396
Study groupRoleWhat they receive
Palliative care consultationExperimentalTimely referral to the palliative care consult team.
Receives: Behavioral: Palliative Care Consult
ControlNo interventionPatients will not be informed about the trial and will receive standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfaction with care

    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.

    Measured: 4 weeks after the start of radiotherapy

Secondary outcomes (8)

  1. Symptom burden

    Symptom burden including physical, psychological, social and spiritual symptoms (Utrecht Symptom Diary (USD-)4D)

    Measured: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks

  2. Pain

    Pain as measured with the Brief Pain Inventory (BPI)

    Measured: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks

  3. Quality of Life

    QoL including physical and emotional functioning, and global QoL (EORTC QLQ-C15-PAL) and Painful Sites, Pain Characteristic, Functional Interference and Psychosocial Aspects (EORTC-QLQ-BM22)

    Measured: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months

  4. Other satisfaction with care outcomes

    Other satisfaction with care outcomes including information, coordination, and overall care (EORTC PATSAT-C33)

    Measured: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months

  5. Overall survival

    Overall survival with a maximum follow-up of two years

    Measured: Max. two years

  6. Palliative care utilization

    Palliative care utilization: within the intervention group, we will measure the number of patients that were allocated to the intervention group and accepted referral (now or later in the disease trajectory) to the PCCT.

    Measured: Through study completion, about 2 years

  7. Palliative care utilization

    Palliative care utilization: within the intervention group, we will measure reasons for refraining from referral to the PCCT, e.g. too early, they think that they are not palliative, they expect no benefit, prior referral to the PCCT.

    Measured: Through study completion

  8. Palliative care utilization

    Palliative care utilization within the both the intervention and control group until death or up to two years post-randomization.

    Measured: Up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start2 Jun 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial will be conducted according to the Trials within Cohorts (TwiCs) design. Patients who provided broad consent to participate in the prospective PRESENT bone metastases cohort study, and who are eligible to participate in TIPZO-RT, will be randomized to either the intervention or control arm. Patients allocated to the intervention arm will be informed about the intervention and asked informed to undergo the intervention, which they can accept or refuse. Patients allocated to the control arm will not be informed, and their data from the cohort will be used comparatively.
Masking
None (open label)
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06805396
Sponsor's protocol ID
25U-0028
Acronym
TIPZO-RT
Status last verified
May 2026
First submitted
20 Jan 2025
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.0349792. eCollection 2026.

    PubMed 42172282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palliative Care Consult in people with Bone Metastases in Subjects With Advanced Cancer and Radiotherapy, run by Roxanne Gal at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roxanne Gal, PhD (+31887555555, R.Gal@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfaction with care (time frame: 4 weeks after the start of radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06805396, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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