Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial (TIPZO-RT)

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.

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+.

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy; Bone Metastases in Subjects With Advanced Cancer
• Intervention / Treatment: Behavioral: Palliative Care Consult

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Roxanne Gal, PhD; Phone Number: +31887555555; Email: R.Gal@umcutrecht.nl

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • Recruiting
    • Meander MC
    • Contact: Roxanne Gal; Phone Number: 00-00000000; Email: r.gal@umcutrecht.nl
  • Gouda, Netherlands
    • Recruiting
    • Groene Hart Ziekenhuis
    • Contact: Anouk van Oss; Phone Number: 00-00000000; Email: a.van_oss@lumc.nl
  • Leiden, Netherlands
    • Recruiting
    • LUMC
    • Contact: Anouk van Oss; Phone Number: 00-00000000; Email: a.van_oss@lumc.nl
  • Leiden, Netherlands
    • Recruiting
    • Alrijne Ziekenhuis
    • Contact: Anouk van Oss; Phone Number: 00-00000000; Email: a.van_oss@lumc.nl
  • Nijmegen, Netherlands
    • Recruiting
    • Radboudumc
    • Contact: Anouk van Oss; Phone Number: 00-00000000; Email: a.van_oss@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palliative care consultation; Timely referral to the palliative care consult team.	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) 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.
No Intervention: Control; Patients will not be informed about the trial and will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks after the start of radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden	Symptom burden including physical, psychological, social and spiritual symptoms (Utrecht Symptom Diary (USD-)4D)	Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks
Pain	Pain as measured with the Brief Pain Inventory (BPI)	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	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)	Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months
Other satisfaction with care outcomes	Other satisfaction with care outcomes including information, coordination, and overall care (EORTC PATSAT-C33)	Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months
Overall survival	Overall survival with a maximum follow-up of two years	Max. two years
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.	Through study completion, about 2 years
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.	Through study completion
Palliative care utilization	Palliative care utilization within the both the intervention and control group until death or up to two years post-randomization.	Up to two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experiences and choices	Semi-structured in-depth interviews with patients randomized to the intervention arm will be performed to obtain insight into patient experiences and choices regarding their consultations with the PCCT.	Through study completion, about 2 years

Collaborators and Investigators

• Sponsor: Roxanne Gal
• Collaborators: Radboud University Medical Center; Leiden University Medical Center; Groene Hart Ziekenhuis; Alrijne Ziekenhuis Leiderdorp; Meander Medical Center
• Investigators: Principal Investigator: Yvette M. van der Linden, Leiden University Medical Center; Principal Investigator: Natasja Raijmakers, Comprehensive Cancer Centre The Netherlands; Principal Investigator: Anouk van Oss, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Radiotherapy; Palliative Care; Advanced Cancer; Quality of Care; Bone Metastases
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Hematologic Diseases; Neoplastic Processes; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: 25U-0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No