%0 Journal Article
%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 P
%A Francis J
%A Cohen J
%A Kapp S
%A De Abreu Lourenco R
%A Beatty L
%A Gray K
%A Jefford M
%A Juraskova I
%A Northouse L
%A de Vleminck A
%A Chang S
%A Yates P
%A Athan S
%A Baptista S
%A Klaic M
%A Philip J
%J JMIR Res Protoc
%V 13
%N 0
%D 2024 Aug 13
%M 39137414
暂无%R 10.2196/55252
%X <B>BACKGROUND: </B>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.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>The study was funded in March 2022. Recruitment commenced in July 2024.<BR><B>CONCLUSIONS: </B>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.<BR><B>BACKGROUND: </B>ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128.<BR><B>UNASSIGNED: </B>PRR1-10.2196/55252.