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

Официальное название

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

Обзор

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+.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Satisfaction with care [Срок оценки: 4 weeks after the start of radiotherapy]

Вторичные конечные точки (8)

• Symptom burden [Срок оценки: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks]
• Pain [Срок оценки: 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 [Срок оценки: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months]
• Other satisfaction with care outcomes [Срок оценки: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months]
• Overall survival [Срок оценки: Max. two years]
• Palliative care utilization [Срок оценки: Through study completion, about 2 years]
• Palliative care utilization [Срок оценки: Through study completion]
• Palliative care utilization [Срок оценки: Up to two years]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Нидерланды · 5 центров

• Meander MC — Amersfoort
• Groene Hart Ziekenhuis — Gouda
• Alrijne Ziekenhuis — Leiden
• LUMC — Leiden
• Radboudumc — Nijmegen

Публикации

• 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

Идентификаторы

NCT: NCT06805396 · 25U-0028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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