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

Roxanne Gal

Status and phase: Not yet enrolling; Phase 2

Conditions: Bone Metastases in Subjects with Advanced Cancer; Radiotherapy

Treatments: Behavioral: Palliative Care Consult

Study type: Interventional

Funder types: Other

Identifiers

NCT06805396

25U-0028

Details and patient eligibility

About

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+.

Enrollment: 246 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 2 patient groups

Palliative care consultation

Experimental group

Description:

Timely referral to the palliative care consult team.

Treatment:

Behavioral: Palliative Care Consult

Control

No Intervention group

Description:

Patients will not be informed about the trial and will receive standard of care.