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)

doi:10.2196/55252

. 2024 Aug 13:13:e55252.

doi: 10.2196/55252.

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)

Peter Hudson^{1

2}, Jill Francis^{3

4

5}, Joachim Cohen², Suzanne Kapp³, Richard De Abreu Lourenco⁶, Lisa Beatty⁷, Kathleen Gray⁸, Michael Jefford^{4

9}, Ilona Juraskova¹⁰, Laurel Northouse¹¹, Aline de Vleminck², Sungwon Chang¹², Patsy Yates¹³, Sophy Athan¹⁴, Shaira Baptista^{3

15}, Marlena Klaic³, Jennifer Philip¹⁶

Affiliations

¹ Centre for Palliative Care, c/o St Vincent's Hospital and The University of Melbourne, Melbourne, Australia.
² End of Life Care Research Group, Vrije Universiteit Brussel, Brussels, Belgium.
³ Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia.
⁴ Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia.
⁵ Centre for Implementation Research, Ottawa Hospital Research, Ottawa, ON, Canada.
⁶ Centre for Health Economics Research and Evaluation (CHERE), University of Technology Sydney, Sydney, Australia.
⁷ College of Education, Psychology and Social Work, Flinders Institute for Mental Health and Wellbeing, Flinders University, Adelaide, Australia.
⁸ Centre for Digital Transformation of Health, The University of Melbourne, Melbourne, Australia.
⁹ Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
¹⁰ Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia.
¹¹ School of Nursing, University of Michigan, Ann Arbor, MI, United States.
¹² Faculty of Health, Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), University of Technology Sydney, Sydney, Australia.
¹³ Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Queensland, Australia.
¹⁴ Cancer Consumer Advisory Committee, Victorian Comprehensive Cancer Centre Alliance, Melbourne, Australia.
¹⁵ School of Public Health and Preventative Medicine, Monash University, Melbourne, Australia.
¹⁶ St. Vincent's Hospital and the Victorian Comprehensive Cancer Centre, The University of Melbourne, Melbourne, Australia.

PMID: 39137414
PMCID: PMC11350297
DOI: 10.2196/55252

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)

Peter Hudson et al. JMIR Res Protoc. 2024.

. 2024 Aug 13:13:e55252.

doi: 10.2196/55252.

Authors

Affiliations

¹ Centre for Palliative Care, c/o St Vincent's Hospital and The University of Melbourne, Melbourne, Australia.
² End of Life Care Research Group, Vrije Universiteit Brussel, Brussels, Belgium.
³ Melbourne School of Health Sciences, The University of Melbourne, Melbourne, Australia.
⁴ Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Australia.
⁵ Centre for Implementation Research, Ottawa Hospital Research, Ottawa, ON, Canada.
⁶ Centre for Health Economics Research and Evaluation (CHERE), University of Technology Sydney, Sydney, Australia.
⁷ College of Education, Psychology and Social Work, Flinders Institute for Mental Health and Wellbeing, Flinders University, Adelaide, Australia.
⁸ Centre for Digital Transformation of Health, The University of Melbourne, Melbourne, Australia.
⁹ Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
¹⁰ Faculty of Science, School of Psychology, University of Sydney, Sydney, Australia.
¹¹ School of Nursing, University of Michigan, Ann Arbor, MI, United States.
¹² Faculty of Health, Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT), University of Technology Sydney, Sydney, Australia.
¹³ Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Queensland, Australia.
¹⁴ Cancer Consumer Advisory Committee, Victorian Comprehensive Cancer Centre Alliance, Melbourne, Australia.
¹⁵ School of Public Health and Preventative Medicine, Monash University, Melbourne, Australia.
¹⁶ St. Vincent's Hospital and the Victorian Comprehensive Cancer Centre, The University of Melbourne, Melbourne, Australia.

PMID: 39137414
PMCID: PMC11350297
DOI: 10.2196/55252

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.

Keywords: Australia; Australian; advanced cancer; cancer; caregiver; caregivers; clinical trial; cost-effectiveness; digital health; digital health intervention; dyad; efficacy; family caregiver; family caregivers; health economics; implementation science; palliative care; psychoeducation; quality of life; self-administered; web-based; web-based intervention; well-being; wellbeing.

©Peter Hudson, Jill Francis, Joachim Cohen, Suzanne Kapp, Richard De Abreu Lourenco, Lisa Beatty, Kathleen Gray, Michael Jefford, Ilona Juraskova, Laurel Northouse, Aline de Vleminck, Sungwon Chang, Patsy Yates, Sophy Athan, Shaira Baptista, Marlena Klaic, Jennifer Philip. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.08.2024.

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Conflict of interest statement

Conflicts of Interest: None declared.

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References

1. Wang H, Yue H, Wang Z, Lu M, Feng D. The relationship between patient-family caregiver congruence/incongruence in acceptance of illness and family caregivers' anticipatory grief. Psychooncology. 2023;32(5):751–759. doi: 10.1002/pon.6121. - DOI - PubMed
1. Deloitte Access Economics. Deloitte Access Economics Pty Ltd; 2015. [2024-06-15]. The economic value of informal care in Australia in 2015. https://www.carersaustralia.com.au/wp-content/uploads/2020/07/access-eco... .
1. Palliative Care Australia National palliative care standards. 5th edition. Palliative Care Australia. 2018. [2024-06-15]. https://palliativecare.org.au/wp-content/uploads/dlm_uploads/2018/11/Pal... .
1. Australian Government Department of Health . National Palliative Care Strategy. Canberra: Department of Health and Aged Care; 2018.
1. Hudson P, Remedios C, Zordan R, Thomas K, Clifton D, Crewdson M, Hall C, Trauer T, Bolleter A, Clarke DM, Bauld C. Guidelines for the psychosocial and bereavement support of family caregivers of palliative care patients. J Palliat Med. 2012;15(6):696–702. doi: 10.1089/jpm.2011.0466. https://europepmc.org/abstract/MED/22385026 - DOI - PMC - PubMed

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[1] Wang H, Yue H, Wang Z, Lu M, Feng D. The relationship between patient-family caregiver congruence/incongruence in acceptance of illness and family caregivers' anticipatory grief. Psychooncology. 2023;32(5):751–759. doi: 10.1002/pon.6121. - DOI - PubMed

[2] Wang H, Yue H, Wang Z, Lu M, Feng D. The relationship between patient-family caregiver congruence/incongruence in acceptance of illness and family caregivers' anticipatory grief. Psychooncology. 2023;32(5):751–759. doi: 10.1002/pon.6121. - DOI - PubMed

[3] Deloitte Access Economics. Deloitte Access Economics Pty Ltd; 2015. [2024-06-15]. The economic value of informal care in Australia in 2015. https://www.carersaustralia.com.au/wp-content/uploads/2020/07/access-eco... .

[4] Deloitte Access Economics. Deloitte Access Economics Pty Ltd; 2015. [2024-06-15]. The economic value of informal care in Australia in 2015. https://www.carersaustralia.com.au/wp-content/uploads/2020/07/access-eco... .

[5] Palliative Care Australia National palliative care standards. 5th edition. Palliative Care Australia. 2018. [2024-06-15]. https://palliativecare.org.au/wp-content/uploads/dlm_uploads/2018/11/Pal... .

[6] Palliative Care Australia National palliative care standards. 5th edition. Palliative Care Australia. 2018. [2024-06-15]. https://palliativecare.org.au/wp-content/uploads/dlm_uploads/2018/11/Pal... .

[7] Australian Government Department of Health . National Palliative Care Strategy. Canberra: Department of Health and Aged Care; 2018.

[8] Australian Government Department of Health . National Palliative Care Strategy. Canberra: Department of Health and Aged Care; 2018.

[9] Hudson P, Remedios C, Zordan R, Thomas K, Clifton D, Crewdson M, Hall C, Trauer T, Bolleter A, Clarke DM, Bauld C. Guidelines for the psychosocial and bereavement support of family caregivers of palliative care patients. J Palliat Med. 2012;15(6):696–702. doi: 10.1089/jpm.2011.0466. https://europepmc.org/abstract/MED/22385026 - DOI - PMC - PubMed

[10] Hudson P, Remedios C, Zordan R, Thomas K, Clifton D, Crewdson M, Hall C, Trauer T, Bolleter A, Clarke DM, Bauld C. Guidelines for the psychosocial and bereavement support of family caregivers of palliative care patients. J Palliat Med. 2012;15(6):696–702. doi: 10.1089/jpm.2011.0466. https://europepmc.org/abstract/MED/22385026 - DOI - PMC - PubMed

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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)

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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)

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