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

Gofton, C; Di Bartolomeo, A; Boutros, R; Zurynski, YA; Stafford-Bell, F; Caldwell, K; McCaughan, G; Zekry, A; Strasser, SI; Levy, M; Sheehan, C; Goodall, S; Davis, JM; Sheahan, L; Liu, K; Greenaway, S; Davison, S; Du Huynh, T; Quadri, Z; Agar, M; George, J

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

Gofton, C Di Bartolomeo, A Boutros, R Zurynski, YA Stafford-Bell, F Caldwell, K McCaughan, G Zekry, A Strasser, SI Levy, M Sheehan, C Goodall, S Davis, JM Sheahan, L Liu, K Greenaway, S Davison, S Du Huynh, T Quadri, Z Agar, M

George, J

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Publisher:: Springer Nature
Publication Type:: Journal Article
Citation:: Trials, 2024, 25, (1), pp. 743
Issue Date:: 2024-11-07

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Field	Value	Language
dc.contributor.author	Gofton, C
dc.contributor.author	Di Bartolomeo, A
dc.contributor.author	Boutros, R
dc.contributor.author	Zurynski, YA
dc.contributor.author	Stafford-Bell, F
dc.contributor.author	Caldwell, K
dc.contributor.author	McCaughan, G
dc.contributor.author	Zekry, A
dc.contributor.author	Strasser, SI
dc.contributor.author	Levy, M
dc.contributor.author	Sheehan, C
dc.contributor.author	Goodall, S
dc.contributor.author	Davis, JM
dc.contributor.author	Sheahan, L
dc.contributor.author	Liu, K
dc.contributor.author	Greenaway, S
dc.contributor.author	Davison, S
dc.contributor.author	Du Huynh, T
dc.contributor.author	Quadri, Z
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.contributor.author	George, J
dc.date.accessioned	2024-11-19T03:12:19Z
dc.date.available	2024-10-30
dc.date.available	2024-11-19T03:12:19Z
dc.date.issued	2024-11-07
dc.identifier.citation	Trials, 2024, 25, (1), pp. 743
dc.identifier.issn	1745-6215
dc.identifier.issn	1745-6215
dc.identifier.uri	http://hdl.handle.net/10453/181977
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	Springer Nature
dc.relation.ispartof	Trials
dc.relation.isbasedon	10.1186/s13063-024-08603-x
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
dc.subject.classification	Cardiovascular System & Hematology
dc.subject.classification	General & Internal Medicine
dc.subject.classification	3202 Clinical sciences
dc.subject.classification	4202 Epidemiology
dc.subject.classification	4203 Health services and systems
dc.subject.mesh	Humans
dc.subject.mesh	Palliative Care
dc.subject.mesh	Liver Neoplasms
dc.subject.mesh	Carcinoma, Hepatocellular
dc.subject.mesh	Quality of Life
dc.subject.mesh	Pragmatic Clinical Trials as Topic
dc.subject.mesh	New South Wales
dc.subject.mesh	Translational Research, Biomedical
dc.subject.mesh	Cost-Benefit Analysis
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Ambulatory Care Facilities
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Humans
dc.subject.mesh	Carcinoma, Hepatocellular
dc.subject.mesh	Liver Neoplasms
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Palliative Care
dc.subject.mesh	Quality of Life
dc.subject.mesh	Ambulatory Care Facilities
dc.subject.mesh	Cost-Benefit Analysis
dc.subject.mesh	New South Wales
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Pragmatic Clinical Trials as Topic
dc.subject.mesh	Translational Research, Biomedical
dc.subject.mesh	Humans
dc.subject.mesh	Palliative Care
dc.subject.mesh	Liver Neoplasms
dc.subject.mesh	Carcinoma, Hepatocellular
dc.subject.mesh	Quality of Life
dc.subject.mesh	Pragmatic Clinical Trials as Topic
dc.subject.mesh	New South Wales
dc.subject.mesh	Translational Research, Biomedical
dc.subject.mesh	Cost-Benefit Analysis
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Ambulatory Care Facilities
dc.subject.mesh	Treatment Outcome
dc.title	Implementing palliative care in hepatocellular carcinoma ambulatory clinics-study protocol for Accelerated translational research in PRImary liver CAncer (APRICA) randomised controlled palliative care trial.
dc.type	Journal Article
utslib.citation.volume	25
utslib.location.activity	England
utslib.for	1102 Cardiorespiratory Medicine and Haematology
utslib.for	1103 Clinical Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT)
pubs.organisational-group	University of Technology Sydney/UTS Groups/INSIGHT: Institute for Innovative Solutions for Well-being and Health
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.date.updated	2024-11-19T03:12:17Z
pubs.issue	1
pubs.publication-status	Published online
pubs.volume	25
utslib.citation.issue	1

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.

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http://hdl.handle.net/10453/181977