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A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol
BACKGROUND: Current international consensus is that ‘early’ referral to palliative care services improves cancer patient and family carer outcomes; however, in practice, these referrals are not routine. Uncertainty about the ‘best time’ to refer has been highlighted as contributing to care variation...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417202/ https://www.ncbi.nlm.nih.gov/pubmed/30915228 http://dx.doi.org/10.1186/s40814-019-0424-7 |
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author | Philip, Jennifer Collins, Anna Le, Brian Sundararajan, Vijaya Brand, Caroline Hanson, Susan Emery, Jon Hudson, Peter Mileshkin, Linda Ganiatsas, Soula |
author_facet | Philip, Jennifer Collins, Anna Le, Brian Sundararajan, Vijaya Brand, Caroline Hanson, Susan Emery, Jon Hudson, Peter Mileshkin, Linda Ganiatsas, Soula |
author_sort | Philip, Jennifer |
collection | PubMed |
description | BACKGROUND: Current international consensus is that ‘early’ referral to palliative care services improves cancer patient and family carer outcomes; however, in practice, these referrals are not routine. Uncertainty about the ‘best time’ to refer has been highlighted as contributing to care variation. Previous work has identified clear disease-specific transition points in the cancer illness which heralded subsequent poor prognosis (less than 6 months) and which, we contest, represent times when palliative care should be routinely introduced as a standardised approach, if not already in place, to maximise patient and carer benefit. This protocol details a trial that will test the feasibility of a novel standardised outpatient model of early palliative care [Standardised Early Palliative Care (STEP Care)] for advanced cancer patients and their family carers, with referrals occurring at the defined disease-specific evidence-based transition points. The aims of this study are to (1) determine the feasibility of conducting a definitive phase 3 randomised trial, which evaluates effectiveness of STEP Care (compared to usual best practice cancer care) for patients with advanced breast or prostate cancer or high grade glioma; (2) examine preliminary efficacy of STEP Care on patient/family caregiver outcomes, including quality of life, mood, symptoms, illness understanding and overall survival; (3) document the impact of STEP Care on quality of end-of-life care; and (4) evaluate the timing of palliative care introduction according to patients, families and health care professionals. METHODS: Phase 2, multicenter, open-label, parallel-arm, randomised controlled trial (RCT) of STEP Care plus standard best practice cancer care versus standard best practice cancer care alone. DISCUSSION: The research will test the feasibility of standardised palliative care introduction based on illness transitions and provide guidance on subsequent development of phase 3 studies of integration. This will directly address the current uncertainty about palliative care timing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000534381. |
format | Online Article Text |
id | pubmed-6417202 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-64172022019-03-26 A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol Philip, Jennifer Collins, Anna Le, Brian Sundararajan, Vijaya Brand, Caroline Hanson, Susan Emery, Jon Hudson, Peter Mileshkin, Linda Ganiatsas, Soula Pilot Feasibility Stud Study Protocol BACKGROUND: Current international consensus is that ‘early’ referral to palliative care services improves cancer patient and family carer outcomes; however, in practice, these referrals are not routine. Uncertainty about the ‘best time’ to refer has been highlighted as contributing to care variation. Previous work has identified clear disease-specific transition points in the cancer illness which heralded subsequent poor prognosis (less than 6 months) and which, we contest, represent times when palliative care should be routinely introduced as a standardised approach, if not already in place, to maximise patient and carer benefit. This protocol details a trial that will test the feasibility of a novel standardised outpatient model of early palliative care [Standardised Early Palliative Care (STEP Care)] for advanced cancer patients and their family carers, with referrals occurring at the defined disease-specific evidence-based transition points. The aims of this study are to (1) determine the feasibility of conducting a definitive phase 3 randomised trial, which evaluates effectiveness of STEP Care (compared to usual best practice cancer care) for patients with advanced breast or prostate cancer or high grade glioma; (2) examine preliminary efficacy of STEP Care on patient/family caregiver outcomes, including quality of life, mood, symptoms, illness understanding and overall survival; (3) document the impact of STEP Care on quality of end-of-life care; and (4) evaluate the timing of palliative care introduction according to patients, families and health care professionals. METHODS: Phase 2, multicenter, open-label, parallel-arm, randomised controlled trial (RCT) of STEP Care plus standard best practice cancer care versus standard best practice cancer care alone. DISCUSSION: The research will test the feasibility of standardised palliative care introduction based on illness transitions and provide guidance on subsequent development of phase 3 studies of integration. This will directly address the current uncertainty about palliative care timing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000534381. BioMed Central 2019-03-14 /pmc/articles/PMC6417202/ /pubmed/30915228 http://dx.doi.org/10.1186/s40814-019-0424-7 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Philip, Jennifer Collins, Anna Le, Brian Sundararajan, Vijaya Brand, Caroline Hanson, Susan Emery, Jon Hudson, Peter Mileshkin, Linda Ganiatsas, Soula A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol |
title | A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol |
title_full | A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol |
title_fullStr | A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol |
title_full_unstemmed | A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol |
title_short | A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: a research protocol |
title_sort | randomised phase ii trial to examine feasibility of standardised, early palliative (step) care for patients with advanced cancer and their families [actrn12617000534381]: a research protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417202/ https://www.ncbi.nlm.nih.gov/pubmed/30915228 http://dx.doi.org/10.1186/s40814-019-0424-7 |
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