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)
- Author(s)
- Hudson, P; Francis, J; Cohen, J; Kapp, S; De Abreu Lourenco, R; Beatty, L; Gray, K; Jefford, M; Juraskova, I; Northouse, L; de Vleminck, A; Chang, S; Yates, P; Athan, S; Baptista, S; Klaic, M; Philip, J;
- Journal Title
- JMIR Research Protocols
- Publication Type
- Research article
- 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 (T(0)) completed prerandomization; first follow-up (T(1); N=346) at 12 weeks post baseline; and second follow-up (T(2)) 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.
- Publisher
- JMIR Publications
- Keywords
- Humans; *Caregivers/psychology; *Neoplasms/therapy/psychology/nursing; *Quality of Life/psychology; Australia; Female; Male; Middle Aged; Digital Health; Australian; advanced cancer; cancer; caregiver; caregivers; clinical trial; cost-effectiveness; 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
- Department(s)
- Health Services Research; Medical Oncology; Australian Cancer Survivorship Centre
- Publisher's Version
- https://doi.org/10.2196/55252
- Open Access at Publisher's Site
https://doi.org/10.2196/55252- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2024-09-12 06:44:25
Last Modified: 2024-09-12 06:49:54