Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial (TIPZO-RT Trial)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 246
- 试验地点
- 5
- 主要终点
- Satisfaction with care
研究概览
简要总结
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+.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Patients allocated to the control arm are not aware that they are part of this trial/the control arm.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Control
Patients will not be informed about the trial and will receive standard of care.
Palliative care consultation
Timely referral to the palliative care consult team.
干预措施: Palliative Care Consult (Behavioral)
结局指标
主要结局
Satisfaction with care
时间窗: 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.
次要结局
- 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)
- Palliative care utilization(Up to two years)
- Other satisfaction with care outcomes(Baseline (start radiotherapy), after 4 and 8 weeks, and 3 and 6 months)
- Overall survival(Max. two years)
- Palliative care utilization(Through study completion, about 2 years)
- Palliative care utilization(Through study completion)
研究者
Roxanne Gal
dr.
UMC Utrecht