TY  - JOUR
AU  - Hudson, Peter
AU  - Francis, Jill
AU  - Cohen, Joachim
AU  - Kapp, Suzanne
AU  - De Abreu Lourenco, Richard
AU  - Beatty, Lisa
AU  - Gray, Kathleen
AU  - Jefford, Michael
AU  - Juraskova, Ilona
AU  - Northouse, Laurel
AU  - de Vleminck, Aline
AU  - Chang, Sungwon
AU  - Yates, Patsy
AU  - Athan, Sophy
AU  - Baptista, Shaira
AU  - Klaic, Marlena
AU  - Philip, Jennifer
PY  - 2024
DA  - 2024/8/13
TI  - 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)
JO  - JMIR Res Protoc
SP  - e55252
VL  - 13
KW  - advanced cancer
KW  - clinical trial
KW  - digital health intervention
KW  - palliative care
KW  - health economics
KW  - implementation science
KW  - wellbeing
KW  - well-being
KW  - cancer
KW  - family caregiver
KW  - family caregivers
KW  - caregivers
KW  - caregiver
KW  - digital health
KW  - quality of life
KW  - dyad
KW  - self-administered
KW  - web-based intervention
KW  - web-based
KW  - Australian
KW  - Australia
KW  - efficacy
KW  - cost-effectiveness
KW  - psychoeducation
AB  - 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 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2024/1/e55252
UR  - https://doi.org/10.2196/55252
DO  - 10.2196/55252
ID  - info:doi/10.2196/55252
ER  -