%0 Journal Article
%@ 1929-0748
%I JMIR Publications
%V 13
%N 
%P e55252
%T 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)
%A Hudson,Peter
%A Francis,Jill
%A Cohen,Joachim
%A Kapp,Suzanne
%A De Abreu Lourenco,Richard
%A Beatty,Lisa
%A Gray,Kathleen
%A Jefford,Michael
%A Juraskova,Ilona
%A Northouse,Laurel
%A de Vleminck,Aline
%A Chang,Sungwon
%A Yates,Patsy
%A Athan,Sophy
%A Baptista,Shaira
%A Klaic,Marlena
%A Philip,Jennifer
%+ Centre for Palliative Care, c/o St Vincent’s Hospital and The University of Melbourne, 41 Victoria Parade, Fitzroy, Melbourne, VIC 3065, Australia, 61 394160000, phudson@unimelb.edu.au
%K advanced cancer
%K clinical trial
%K digital health intervention
%K palliative care
%K health economics
%K implementation science
%K wellbeing
%K well-being
%K cancer
%K family caregiver
%K family caregivers
%K caregivers
%K caregiver
%K digital health
%K quality of life
%K dyad
%K self-administered
%K web-based intervention
%K web-based
%K Australian
%K Australia
%K efficacy
%K cost-effectiveness
%K psychoeducation
%D 2024
%7 13.8.2024
%9 Protocol
%J JMIR Res Protoc
%G English
%X 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 
%R 10.2196/55252
%U https://www.researchprotocols.org/2024/1/e55252
%U https://doi.org/10.2196/55252