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

Phase 2

Not yet recruiting

• Conditions: Bone Metastases in Subjects with Advanced Cancer; Radiotherapy

• Registration Number: NCT06805396
• Lead Sponsor: Roxanne Gal

Brief 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 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+.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Study Start: 2025-04-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 246

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Satisfaction with care	4 weeks after the start of radiotherapy	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.

Secondary Outcome Measures

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