Clinical trial NCT06805396: Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: a Randomized Trial
Official title: Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: a Randomized Trial (TIPZO-RT Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Bone Metastases in Subjects with Advanced Cancer
Radiotherapy
Keywords: Palliative Care
Bone Metastases
Radiotherapy
Advanced Cancer
Quality of Life
Quality of Care
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Radboud University Medical Center
First posted: 2025-02-03
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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+.


Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction with care
timeFrame: 4 weeks after the start of radiotherapy
Secondary outcomes:
measure: Symptom burden
timeFrame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks
measure: Pain
timeFrame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months, and the BPI also after 2 and 6 weeks
measure: Quality of Life
timeFrame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months
measure: Other satisfaction with care outcomes
timeFrame: Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months
measure: Overall survival
timeFrame: Max. two years
measure: Palliative care utilization
timeFrame: Through study completion, about 2 years
measure: Palliative care utilization
timeFrame: Through study completion
measure: Palliative care utilization
timeFrame: Up to two years
Other outcomes:
measure: Patient experiences and choices
timeFrame: Through study completion, about 2 years
Locations:
Study officials:
affiliation: Leiden University Medical Center
name: Yvette M. van der Linden
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive Cancer Centre The Netherlands
name: Natasja Raijmakers
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: Anouk van Oss
role: PRINCIPAL_INVESTIGATOR
References: