A Phase 2 interventional study of Palliative Care Consult in Bone Metastases in Subjects With Advanced Cancer and Radiotherapy, sponsored by Roxanne Gal. Recruiting at 5 sites in Netherlands. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Roxanne Gal · Phase 2, Interventional, and Supportive care
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+.
This is the only study on the registry with Roxanne Gal as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Timely referral to the palliative care consult team.
Behavioral: Palliative Care Consult
Patients will not be informed about the trial and will receive standard of care.
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.
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.
Time frame: 4 weeks after the start of radiotherapy
Symptom burden
Symptom burden including physical, psychological, social and spiritual symptoms (Utrecht Symptom Diary (USD-)4D)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to two years
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.
Time frame: Through study completion, about 2 years
Plan to share: Undecided
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