Implementing palliative care in hepatocellular carcinoma ambulatory clinics-study protocol for Accelerated translational research in PRImary liver CAncer (APRICA) randomised controlled palliative care trial.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2024-11-07 DOI:10.1186/s13063-024-08603-x
Cameron Gofton, Anna Di Bartolomeo, Rose Boutros, Yvonne A Zurynski, Fiona Stafford-Bell, Kim Caldwell, Geoffrey McCaughan, Amany Zekry, Simone I Strasser, Miriam Levy, Caitlin Sheehan, Stephen Goodall, Jan Maree Davis, Linda Sheahan, Ken Liu, Sally Greenaway, Scott Davison, Thang Du Huynh, Zujaj Quadri, Meera Agar, Jacob George
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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ACTRN12623000010695. Registered on September 1, 2023.

在肝细胞癌非住院诊所实施姑息治疗--PRImary 肝癌加速转化研究(APRICA)随机对照姑息治疗试验的研究方案。
背景:为晚期癌症患者整合症状和姑息治疗已在许多肿瘤类型中得到确立,但其在肝细胞癌(HCC)患者中的作用尚未得到明确界定。本研究旨在评估一项干预措施的临床效果和成本效益,该干预措施涉及一整套策略,旨在评估和治疗在新南威尔士州(NSW)四家大都市三甲医院就诊的成年门诊肝细胞癌患者的姑息治疗症状和需求:该试验将采用基于群组的实用随机对照设计,以非住院HCC服务为群组。如果HCC患者患有巴塞罗那临床肝癌(BCLC)A期且肿瘤处于活动期,或目前或之前被诊断患有BCLC B期或C期疾病(无论肿瘤是否处于活动期),则将被招募。BCLCD期患者将被排除在外,因为姑息治疗是这类患者的标准治疗方法(SOC)。分组地点将被随机分配到研究干预或对照组,在对照组中,患者将按照 SOC 进行治疗。所有参与者将在定期门诊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。在干预地点,任何肝脏特异性 ESAS 症状得分≥ 5 分的患者将被转诊至姑息治疗医生处进行咨询。主要临床结果是在 3 个月内肝脏特异性 ESAS 评分≥5 分的所有症状改善 50%,主要实施结果是在所有参加门诊预约的参与者中记录肝脏特异性 ESAS 评分≥80% 的患者。参加试验的患者的护理人员将被邀请在每次就诊时执行护理人员支持需求评估工具:该试验将告知姑息关怀的早期参与是否能显著减轻与 HCC 相关的症状负担。如果发现有效,则应将姑息关怀咨询的提前实施纳入HCC治疗指南:试验注册:ACTRN12623000010695。注册日期:2023年9月1日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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