Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau).

Hudson, P; Francis, J; Cohen, J; Kapp, S; De Abreu Lourenco, R; Beatty, L; Gray, K; Jefford, M; Juraskova, I; Northouse, L; de Vleminck, A; Chang, S; Yates, P; Athan, S; Baptista, S; Klaic, M; Philip, J

Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau).

Hudson, P Francis, J Cohen, J Kapp, S De Abreu Lourenco, R

Beatty, L Gray, K Jefford, M Juraskova, I Northouse, L de Vleminck, A Chang, S

Yates, P Athan, S Baptista, S Klaic, M Philip, J

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Publisher:: JMIR PUBLICATIONS, INC
Publication Type:: Journal Article
Citation:: JMIR Res Protoc, 2024, 13, pp. e55252
Issue Date:: 2024-08-13

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Field	Value	Language
dc.contributor.author	Hudson, P
dc.contributor.author	Francis, J
dc.contributor.author	Cohen, J
dc.contributor.author	Kapp, S
dc.contributor.author	De Abreu Lourenco, R https://orcid.org/0000-0002-5978-8774
dc.contributor.author	Beatty, L
dc.contributor.author	Gray, K
dc.contributor.author	Jefford, M
dc.contributor.author	Juraskova, I
dc.contributor.author	Northouse, L
dc.contributor.author	de Vleminck, A
dc.contributor.author	Chang, S https://orcid.org/0000-0003-0723-3192
dc.contributor.author	Yates, P
dc.contributor.author	Athan, S
dc.contributor.author	Baptista, S
dc.contributor.author	Klaic, M
dc.contributor.author	Philip, J
dc.date.accessioned	2024-12-13T05:35:06Z
dc.date.available	2024-05-21
dc.date.available	2024-12-13T05:35:06Z
dc.date.issued	2024-08-13
dc.identifier.citation	JMIR Res Protoc, 2024, 13, pp. e55252
dc.identifier.issn	1929-0748
dc.identifier.issn	1929-0748
dc.identifier.uri	http://hdl.handle.net/10453/182529
dc.description.abstract	BACKGROUND: Advanced cancer significantly impacts patients' and family caregivers' quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery. OBJECTIVE: The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system. METHODS: FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points-baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline. RESULTS: The study was funded in March 2022. Recruitment commenced in July 2024. CONCLUSIONS: If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support. TRIAL REGISTRATION: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55252.
dc.format	Electronic
dc.language	eng
dc.publisher	JMIR PUBLICATIONS, INC
dc.relation.ispartof	JMIR Res Protoc
dc.relation.isbasedon	10.2196/55252
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services
dc.subject.classification	4203 Health services and systems
dc.subject.classification	4206 Public health
dc.subject.mesh	Humans
dc.subject.mesh	Caregivers
dc.subject.mesh	Neoplasms
dc.subject.mesh	Quality of Life
dc.subject.mesh	Australia
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Digital Health
dc.subject.mesh	Humans
dc.subject.mesh	Neoplasms
dc.subject.mesh	Quality of Life
dc.subject.mesh	Middle Aged
dc.subject.mesh	Caregivers
dc.subject.mesh	Australia
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Digital Health
dc.subject.mesh	Humans
dc.subject.mesh	Caregivers
dc.subject.mesh	Neoplasms
dc.subject.mesh	Quality of Life
dc.subject.mesh	Australia
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Digital Health
dc.title	Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau).
dc.type	Journal Article
utslib.citation.volume	13
utslib.location.activity	Canada
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
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/School of Public Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/INSIGHT: Institute for Innovative Solutions for Well-being and Health/Centre for Health Economics Research and Evaluation (CHERE)
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
pubs.organisational-group	University of Technology Sydney/UTS Groups/Centre for Health Technologies (CHT)
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	2024-12-13T05:35:04Z
pubs.publication-status	Published online
pubs.volume	13

Abstract:

BACKGROUND: Advanced cancer significantly impacts patients' and family caregivers' quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery. OBJECTIVE: The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system. METHODS: FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points-baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline. RESULTS: The study was funded in March 2022. Recruitment commenced in July 2024. CONCLUSIONS: If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support. TRIAL REGISTRATION: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55252.

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http://hdl.handle.net/10453/182529