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NCT Number: NCT06805396

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

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+.

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Key information

Conditions

Bone Metastases in Subjects With Advanced Cancer Radiotherapy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Meander MC, Amersfoort, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Satisfaction with care

    Time frame: 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 outcomes

  1. Symptom burden

    Time frame: 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)

  2. Pain

    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 as measured with the Brief Pain Inventory (BPI)

  3. Quality of Life

    Time frame: 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)

  4. Other satisfaction with care outcomes

    Time frame: 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)

  5. Overall survival

    Time frame: Max. two years

    Overall survival with a maximum follow-up of two years

  6. Palliative care utilization

    Time frame: Through study completion, about 2 years

    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.

  7. Palliative care utilization

    Time frame: Through study completion

    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.

  8. Palliative care utilization

    Time frame: Up to two years

    Palliative care utilization within the both the intervention and control group until death or up to two years post-randomization.

Other outcomes

  1. Patient experiences and choices

    Time frame: Through study completion, about 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Roxanne Gal, PhD

CONTACT

[email protected]

+31887555555

Sponsors and collaborators

Lead sponsor

Roxanne Gal

Other

Collaborators

  • Alrijne Ziekenhuis Leiderdorp
  • Groene Hart Ziekenhuis
  • Leiden University Medical Center
  • Meander Medical Center
  • Radboud University Medical Center

Registry information

Official study title

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

Acronym: TIPZO-RT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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