Research AppraisalRandomised Controlled Trial

Timely Integration of specialist palliative care into oncology care for patients receiving radiotherapy for bone metastases: A study protocol for the TIPZO-RT Randomized Controlled Trial

PloS onevan Oss, Anouk, van der Velden, Joanne M, Verkooijen, Helena M et al.DOI

Clinical Snapshot

65CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — PopulationPatients with advanced cancer referred for radiotherapy for symptomatic bone metastases
I — InterventionSystematic offer of palliative care consultation team (PCCT) consultation
C — ComparatorUsual care without systematic palliative care consultation offer
O — OutcomesPrimary: patient satisfaction with care (EORTC PATSAT-C33). Secondary: symptom burden, quality of life, overall survival, palliative care utilization

Bottom Line

The TIPZO-RT trial protocol describes a pragmatic randomised controlled trial evaluating systematic palliative care consultation for patients receiving radiotherapy for bone metastases. Using an innovative Trials within Cohorts design, the study aims to determine whether proactive palliative care integration improves patient satisfaction compared to usual care. While the protocol demonstrates methodological rigour with comprehensive outcome measurement, the inability to blind participants and providers introduces potential bias. The pragmatic design enhances real-world applicability, particularly relevant for Australian cancer centres seeking evidence-based approaches to palliative care integration. The study addresses a critical gap in optimal timing of specialist palliative care referral, with potential implications for healthcare policy and clinical practice guidelines. Results will inform systematic approaches to palliative care integration in oncology settings, though generalisability may be limited by single-centre design.

Evidence: Moderate

Key Findings

  • P Value: Not yet determined - protocol stage

  • Effect Size: Not yet determined - protocol stage

  • Primary Outcome: Patient satisfaction with care measured by EORTC PATSAT-C33 at 4 weeks

  • Nnt Or Sensitivity: Not yet determined - protocol stage

  • Confidence Interval: Not yet determined - protocol stage

Clinical Application

Requires established palliative care consultation teams and systematic referral processes Relevant to Australian cancer centres with palliative care teams. Aligns with Cancer Australia guidelines for integrated palliative care. May inform Medicare Benefits Schedule considerations for palliative care consultations Patients with advanced cancer and bone metastases requiring palliative radiotherapy in tertiary care settings

Abstract

BACKGROUND: Patients living with advanced cancer often benefit from palliative care. Timely referral to specialist palliative care improves quality of life and reduces potentially inappropriate end-of-life care. Despite these benefits, specialist palliative care is frequently introduced late and inconsistently. This study evaluates whether systematically offering a consultation with the hospital palliative care consultation team (PCCT) to all patients referred for radiotherapy for symptomatic bone metastases improves satisfaction with care. PATIENTS AND METHODS: The Timely Integration of Palliative Care in Oncology care for patients referred for palliative RadioTherapy (TIPZO-RT) trial follows the Trials within Cohorts design and is embedded within the PRospective Evaluation of interventional StudiEs on boNe meTastases (PRESENT+) cohort. Following cohort enrollment, 246 patients will be randomized (1:1) to either the intervention or control group. Patients in the intervention group are offered a PCCT consultation, which they may accept or refrain from. Patients in the control group are not informed about the trial and continue to receive usual care. After four weeks, patient satisfaction with care (affective behavior, EORTC Satisfaction with Cancer Care core questionnaire (EORTC PATSAT-C33)) will be compared between the groups. Secondary outcomes include symptom burden, quality of life, overall survival, and palliative care utilization. Additionally, in the intervention group, patients' experiences with the consultation are evaluated. DISCUSSION: Integrating palliative care into oncological care for patients with advanced cancer is essential to deliver comprehensive, patient-centered care that addresses physical, psychosocial and spiritual needs. This pragmatic study may provide evidence to support timely integration of specialist palliative care for all patients with bone metastases who may benefit from specialist palliative care. Using the Trials within Cohorts design, this study generates real-world evidence on the acceptance or need for a consultation with the PCCT, while minimizing disappointment or response bias, as patients in the control group are not informed. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT06805396. Registered on 25-03-2025.

References

  1. 1.van Oss, A., van der Velden, J. M., Verkooijen, H. M., van Jaarsveld, R., Hesselmann, G. M., Kuip, E. J. M., Westhoff, P. G., Raijmakers, N. J. H., van der Linden, Y. M., & Gal, R. (2026). Timely Integration of specialist palliative care into oncology care for patients receiving radiotherapy for bone metastases: A study protocol for the TIPZO-RT Randomized Controlled Trial. PLoS One. https://doi.org/10.1371/journal.pone.0349792
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