Storr Liver Centre, Westmead Hospital, WSLHD, Westmead Institute for Medical Researchand, University of Sydney, Westmead, Australia.
Royal North Shore Hospital, St Leonards, Australia.
Trials. 2024 Nov 7;25(1):743. doi: 10.1186/s13063-024-08603-x.
Integration of symptom and palliative care for people with advanced cancer is established in many tumour types, but its role in people with hepatocellular carcinoma (HCC) has not been clearly defined. This study aims to evaluate the clinical and cost effectiveness of an intervention involving a suite of strategies designed to assess and treat palliative care symptoms and needs in adult outpatients with HCC attending four New South Wales (NSW) metropolitan tertiary hospitals.
This trial will use a pragmatic cluster-based randomised-controlled design, with ambulatory HCC services as the clusters. HCC patients will be recruited if they have Barcelona Clinical Liver Cancer (BCLC) stage A disease with active tumour or a current or prior diagnosis of BCLC stage B or C disease regardless of tumour activity. Patients with BCLC stage D disease will be excluded as palliative care is the standard of care (SOC) in this group. Cluster sites will be randomised to the study intervention or control where patients are managed according to SOC. All participants will complete the liver-specific Edmonton Symptom Assessment Scale (ESAS) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at regular ambulatory clinic appointments. At intervention sites, patients scoring ≥ 5 on any liver-specific ESAS symptom will be referred to palliative care physicians for consultation. The primary clinical outcome will be improvement in all symptoms scored ≥ 5 on the liver-specific ESAS by 50% within 3 months and the primary implementation outcome will recording the liver-specific ESAS in ≥ 80% of all participants attending clinic appointments. Caregivers of patients enrolled in the trial will be invited to perform Carer Support Needs Assessment Tool at each appointment.
This trial will inform if earlier palliative care involvement significantly reduces the symptom burden associated with HCC. If found to be effective, earlier implementation of palliative care consultation should be included in HCC treatment guidelines.
ACTRN12623000010695. Registered on September 1, 2023.
在许多肿瘤类型中，已经确立了将症状和姑息治疗整合到晚期癌症患者中的方法，但在肝细胞癌（HCC）患者中的作用尚未明确。本研究旨在评估一项干预措施的临床和成本效益，该干预措施包括一系列旨在评估和治疗在新南威尔士州（NSW）四家大都市三级医院就诊的成年 HCC 门诊患者姑息治疗症状和需求的策略。
本试验将采用实用的基于群组的随机对照设计，以门诊 HCC 服务为群组。如果患者具有巴塞罗那临床肝癌（BCLC）分期 A 疾病且有活动性肿瘤，或当前或既往诊断为 BCLC 分期 B 或 C 疾病，无论肿瘤活性如何，都将招募 HCC 患者。将排除 BCLC 分期 D 疾病的患者，因为姑息治疗是该组的标准治疗（SOC）。群组站点将被随机分配到研究干预或对照中，其中患者根据 SOC 进行管理。所有参与者将在常规门诊预约时完成肝脏特异性埃德蒙顿症状评估量表（ESAS）和欧洲癌症研究与治疗组织生活质量问卷。在干预站点，如果任何肝脏特异性 ESAS 症状评分≥5 的患者将被转介给姑息治疗医生进行咨询。主要临床结局是在 3 个月内所有肝脏特异性 ESAS 评分≥5 的症状改善 50%，主要实施结局是在所有参加门诊预约的患者中记录≥80%的肝脏特异性 ESAS。试验中纳入的患者的照顾者将被邀请在每次预约时使用照顾者支持需求评估工具。
本试验将确定更早的姑息治疗介入是否能显著减轻 HCC 相关的症状负担。如果被证明有效，姑息治疗咨询的早期实施应纳入 HCC 治疗指南。
ACTRN12623000010695。于 2023 年 9 月 1 日注册。
