Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study).

Green, A; Newton, RU; Smith, DP; Tuffaha, H; Galvão, DA; Heathcote, P; Patel, MI; Christie, D; Egger, S; Sara, SA; Heneka, N; Chambers, SK; Dunn, J

Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study).

Green, A

Newton, RU Smith, DP Tuffaha, H Galvão, DA Heathcote, P Patel, MI Christie, D Egger, S Sara, SA Heneka, N

Chambers, SK Dunn, J

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Publisher:: BMJ PUBLISHING GROUP
Publication Type:: Journal Article
Citation:: BMJ Open, 2024, 14, (3), pp. e084412
Issue Date:: 2024-03-23

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Field	Value	Language
dc.contributor.author	Green, A https://orcid.org/0000-0002-7541-3665
dc.contributor.author	Newton, RU
dc.contributor.author	Smith, DP
dc.contributor.author	Tuffaha, H
dc.contributor.author	Galvão, DA
dc.contributor.author	Heathcote, P
dc.contributor.author	Patel, MI
dc.contributor.author	Christie, D
dc.contributor.author	Egger, S
dc.contributor.author	Sara, SA
dc.contributor.author	Heneka, N https://orcid.org/0000-0001-8102-1871
dc.contributor.author	Chambers, SK
dc.contributor.author	Dunn, J
dc.date.accessioned	2024-08-06T03:20:11Z
dc.date.available	2024-02-20
dc.date.available	2024-08-06T03:20:11Z
dc.date.issued	2024-03-23
dc.identifier.citation	BMJ Open, 2024, 14, (3), pp. e084412
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/180107
dc.description.abstract	INTRODUCTION: Androgen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care needs. An essential part of quality cancer care is survivorship care. To date, an optimal effective approach to survivorship care for men with prostate cancer on ADT has not been described. This protocol describes a randomised trial of tele-based nurse-led survivorship that addresses this knowledge gap: (1) determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life (HR-QoL) in men with prostate cancer undergoing ADT and (2) evaluate PCEssentials implementation strategies and outcomes, including cost-effectiveness, compared with usual care. METHODS AND ANALYSIS: This is an effectiveness-implementation hybrid (type 1) trial with participants randomised to one of two arms: (1) minimally enhanced usual care and (2) nurse-led prostate cancer survivorship essentials (PCEssentials) delivered over four tele-based sessions, with a booster session 5 months after session 1. Eligible participants are Australian men with prostate cancer commencing ADT and expected to be on ADT for a minimum of 12 months. Participants are followed up at 3, 6 and 12 months postrecruitment. Primary outcomes are HR-QoL and self-efficacy. Secondary outcomes are psychological distress, insomnia, fatigue and physical activity. A concurrent process evaluation with participants and study stakeholders will be undertaken to determine effectiveness of delivery of PCEssentials. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Metro South Health HREC (HREC/2021/QMS/79429). All participants are required to provide written informed consent. Outcomes of this trial will be published in peer-reviewed journals. The findings will be presented at conferences and meetings, local hospital departments, participating organisations/clinical services, and university seminars, and communicated at community and consumer-led forums. TRIAL REGISTRATION NUMBER: ACTRN12622000025730.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ PUBLISHING GROUP
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2024-084412
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.classification	52 Psychology
dc.subject.mesh	Male
dc.subject.mesh	Humans
dc.subject.mesh	Prostatic Neoplasms
dc.subject.mesh	Quality of Life
dc.subject.mesh	Androgen Antagonists
dc.subject.mesh	Androgens
dc.subject.mesh	Prostate
dc.subject.mesh	Survivorship
dc.subject.mesh	Cancer Survivors
dc.subject.mesh	Nurse's Role
dc.subject.mesh	Australia
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Prostate
dc.subject.mesh	Humans
dc.subject.mesh	Prostatic Neoplasms
dc.subject.mesh	Androgen Antagonists
dc.subject.mesh	Androgens
dc.subject.mesh	Nurse's Role
dc.subject.mesh	Quality of Life
dc.subject.mesh	Australia
dc.subject.mesh	Male
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Cancer Survivors
dc.subject.mesh	Survivorship
dc.subject.mesh	Male
dc.subject.mesh	Humans
dc.subject.mesh	Prostatic Neoplasms
dc.subject.mesh	Quality of Life
dc.subject.mesh	Androgen Antagonists
dc.subject.mesh	Androgens
dc.subject.mesh	Prostate
dc.subject.mesh	Survivorship
dc.subject.mesh	Cancer Survivors
dc.subject.mesh	Nurse's Role
dc.subject.mesh	Australia
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.title	Prostate Cancer Survivorship Essentials for men with prostate cancer on androgen deprivation therapy: protocol for a randomised controlled trial of a tele-based nurse-led survivorship care intervention (PCEssentials Hormone Therapy Study).
dc.type	Journal Article
utslib.citation.volume	14
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health 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/Faculty of Health/IMPACCT
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
dc.date.updated	2024-08-06T03:20:10Z
pubs.issue	3
pubs.publication-status	Published online
pubs.volume	14
utslib.citation.issue	3

Abstract:

INTRODUCTION: Androgen deprivation therapy (ADT) is commonly used to treat men with locally advanced or metastatic prostate cancer. Men receiving ADT experience numerous side effects and frequently report unmet supportive care needs. An essential part of quality cancer care is survivorship care. To date, an optimal effective approach to survivorship care for men with prostate cancer on ADT has not been described. This protocol describes a randomised trial of tele-based nurse-led survivorship that addresses this knowledge gap: (1) determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life (HR-QoL) in men with prostate cancer undergoing ADT and (2) evaluate PCEssentials implementation strategies and outcomes, including cost-effectiveness, compared with usual care. METHODS AND ANALYSIS: This is an effectiveness-implementation hybrid (type 1) trial with participants randomised to one of two arms: (1) minimally enhanced usual care and (2) nurse-led prostate cancer survivorship essentials (PCEssentials) delivered over four tele-based sessions, with a booster session 5 months after session 1. Eligible participants are Australian men with prostate cancer commencing ADT and expected to be on ADT for a minimum of 12 months. Participants are followed up at 3, 6 and 12 months postrecruitment. Primary outcomes are HR-QoL and self-efficacy. Secondary outcomes are psychological distress, insomnia, fatigue and physical activity. A concurrent process evaluation with participants and study stakeholders will be undertaken to determine effectiveness of delivery of PCEssentials. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Metro South Health HREC (HREC/2021/QMS/79429). All participants are required to provide written informed consent. Outcomes of this trial will be published in peer-reviewed journals. The findings will be presented at conferences and meetings, local hospital departments, participating organisations/clinical services, and university seminars, and communicated at community and consumer-led forums. TRIAL REGISTRATION NUMBER: ACTRN12622000025730.

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