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

NCT06805396 | Not Yet Recruiting Phase 2

• 1 other identifier: 25U-0028
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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+.

Conditions

Bone Metastases in Subjects with Advanced Cancer; Radiotherapy

Keywords

Palliative Care; Bone Metastases; Radiotherapy; Advanced Cancer; Quality of Life; Quality of Care

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks after the start of radiotherapy

Secondary Outcomes (8)

• Symptom burden

  Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks

• Pain

  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

  Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months

• Other satisfaction with care outcomes

  Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months

• Overall survival

  Max. two years

Other Outcomes (1)

• Patient experiences and choices

  Through study completion, about 2 years

Study Arms (2)

Palliative care consultation

EXPERIMENTAL

Timely referral to the palliative care consult team.

Behavioral: Palliative Care Consult

Control

NO INTERVENTION

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

Interventions

Palliative Care Consult BEHAVIORAL

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.

Palliative care consultation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roxanne Gal: lead
• Leiden University Medical Center: collaborator
• Radboud University Medical Center: collaborator

Study Officials

• Yvette M. van der Linden

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Natasja Raijmakers

  Comprehensive Cancer Centre The Netherlands

  PRINCIPAL INVESTIGATOR

• Anouk van Oss

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roxanne Gal, PhD

CONTACT

+31887555555; R.Gal@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients allocated to the control arm are not aware that they are part of this trial/the control arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dr.

Model Details: The trial will be conducted according to the Trials within Cohorts (TwiCs) design. Patients who provided broad consent to participate in the prospective PRESENT bone metastases cohort study, and who are eligible to participate in TIPZO-RT, will be randomized to either the intervention or control arm. Patients allocated to the intervention arm will be informed about the intervention and asked informed to undergo the intervention, which they can accept or refuse. Patients allocated to the control arm will not be informed, and their data from the cohort will be used comparatively.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-01