A self-management psychoeducational eHealth program to support and empower people with advanced cancer and their family caregivers: Development using the scrum methodology

Goethem, Vincent Van; Dierickx, Sigrid; Matthys, Orphé; Northouse, Laurel; Lund, Line; Jordan, Catherine; Turola, Elena; Wel, Maaike van der; Scott, David A.; Harding, Richard; Deliens, Luc; Lapeire, Lore; Hudson, Peter; Vleminck, Aline De; Cohen, Joachim

doi:10.1016/j.invent.2023.100659

Cited by 2 publications

(1 citation statement)

References 39 publications

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“…The strong empirical base and utility of the FOCUS (USA) intervention have been acknowledged by the European Union (EU) through successful grant funding awarded to test European-adapted versions of both programs (in-person (FOCUS+) and digital (iFOCUS) in a Phase III trial, currently being conducted across six countries (England, Ireland, Belgium, Denmark, Netherlands and Italy) [39,40,41] .…”

Section: Focus Intervention Backgroundmentioning

confidence: 99%

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,

Francis,

Cohen

et al. 2024

JMIR Res Protoc

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Background: Advanced cancer significantly impacts patients' and family carers' quality of life. When patients and carers are supported concurrently as a dyad, the wellbeing of each person is optimised. FOCUS is a dyadic, psychoeducational intervention developed in the USA, shown to improve the wellbeing and Quality of Life (QoL) of patients with advanced cancer and their primary carers. Originally a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery.Objective: To: 1) adapt FOCUS to the Australian context (FOCUSau); 2) evaluate the effectiveness of FOCUSau in improving the emotional wellbeing and self-efficacy of patients with advanced cancer and their primary carer relative to a usual care control group, 3) compare health care utilisation between the intervention and control groups; and 4) assess the acceptability, feasibility and scalability of FOCUSau in order to inform future sustainable 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 the acceptability, feasibility and scalability we will use a pragmatic phase III hybrid effectiveness-implementation trial, with an integrated research design that includes a digital health evaluation. Participants will include patients with cancer who are over 18 years of age; able to access the internet and can identify a primary support person/carer who can be also approached for participation. Sample size: 173 dyads in each arm (i.e. 346 dyads in total). Patient-carer dyad data will be collected at three time points: baseline (T0) completed pre-randomisation, first follow-up (T1) at 12 weeks post-baseline; second follow-up (T2) at 24 weeks post-baseline.Results: Funded March 2022. Recruitment anticipated to commence by March 2024.Conclusions: If shown to be effective, this intervention will improve the wellbeing of patients with advanced cancer and their family carer, regardless of their location or current level of health care support. Clinical Trial: ClinicalTrials.gov on the 13th of

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Section: Focus Intervention Backgroundmentioning

confidence: 99%

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,

Francis,

Cohen

et al. 2024

JMIR Res Protoc

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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) (Preprint)

Hudson,

Francis,

Cohen

et al. 2023

Preprint

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BACKGROUND Advanced cancer significantly impacts patients' and family carers' quality of life. When patients and carers are supported concurrently as a dyad, the wellbeing of each person is optimised. FOCUS is a dyadic, psychoeducational intervention developed in the USA, shown to improve the wellbeing and Quality of Life (QoL) of patients with advanced cancer and their primary carers. Originally a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery. OBJECTIVE To: 1) adapt FOCUS to the Australian context (FOCUSau); 2) evaluate the effectiveness of FOCUSau in improving the emotional wellbeing and self-efficacy of patients with advanced cancer and their primary carer relative to a usual care control group, 3) compare health care utilisation between the intervention and control groups; and 4) assess the acceptability, feasibility and scalability of FOCUSau in order to inform future sustainable 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 the acceptability, feasibility and scalability we will use a pragmatic phase III hybrid effectiveness-implementation trial, with an integrated research design that includes a digital health evaluation. Participants will include patients with cancer who are over 18 years of age; able to access the internet and can identify a primary support person/carer who can be also approached for participation. Sample size: 173 dyads in each arm (i.e. 346 dyads in total). Patient-carer dyad data will be collected at three time points: baseline (T0) completed pre-randomisation, first follow-up (T1) at 12 weeks post-baseline; second follow-up (T2) at 24 weeks post-baseline. RESULTS Funded March 2022. Recruitment anticipated to commence by March 2024. CONCLUSIONS If shown to be effective, this intervention will improve the wellbeing of patients with advanced cancer and their family carer, regardless of their location or current level of health care support. CLINICALTRIAL ClinicalTrials.gov on the 13th of October 2023 (ID: NCT06082128)

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A self-management psychoeducational eHealth program to support and empower people with advanced cancer and their family caregivers: Development using the scrum methodology

Cited by 2 publications

References 39 publications

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)

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)

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) (Preprint)

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