Centre for Palliative Care, c/o St Vincent's Hospital and The University of Melbourne, Melbourne, Australia.
End of Life Care Research Group, Vrije Universiteit Brussel, Brussels, Belgium.
JMIR Res Protoc. 2024 Aug 13;13:e55252. doi: 10.2196/55252.
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.
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.
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) completed prerandomization; first follow-up (T; N=346) at 12 weeks post baseline; and second follow-up (T) at 24 weeks post baseline.
The study was funded in March 2022. Recruitment commenced in July 2024.
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.
ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55252.
晚期癌症严重影响患者及其家庭照顾者的生活质量。当患者和照顾者作为一个对子得到支持时，每个人的幸福感都会得到优化。家庭、展望、沟通、不确定性、症状管理（FOCUS）是一种在美国开发的、针对双体的心理教育干预措施，已被证明可改善晚期癌症患者及其主要照顾者的幸福感和生活质量。最初，FOCUS 是一种由护士提供的面对面干预措施，现已改编为适用于欧洲的自我管理网络干预措施。
本研究的目的是：（1）将 FOCUS 适应澳大利亚环境（FOCUSau）；（2）评估 FOCUSau 对改善晚期癌症患者及其主要照顾者的情绪健康和自我效能的有效性，与常规护理对照组相比；（3）比较干预组和对照组之间的医疗保健使用情况；（4）评估 FOCUSau 的可接受性、可行性和可扩展性，以便为该干预措施在澳大利亚医疗保健系统中的可持续实施提供信息。
在试验开始前，将使用迭代利益相关者反馈过程来创建 FOCUSau。为了检验 FOCUSau 的疗效和成本效益，并评估其可接受性、可行性和可扩展性，我们将进行一项混合类型 1 实施研究，包括一项 3 期（临床效果）试验和一项观察性实施研究。参与者将包括年龄大于 18 岁、能够访问互联网、并且能够识别主要支持人员或护理人员的癌症患者。样本量由每组 173 对（即总共 346 对）组成。患者-照顾者对数据将在 3 个时间点收集：基线（T）完成预随机化；第一次随访（T1；N=346）在基线后 12 周；和第二次随访（T2）在基线后 24 周。
该研究于 2022 年 3 月获得资金。招募于 2024 年 7 月开始。
如果被证明有效，该干预措施将改善晚期癌症患者及其家庭照顾者的幸福感，无论他们的位置或当前的医疗保健支持水平如何。
ClinicalTrials.gov NCT06082128；https://clinicaltrials.gov/study/NCT06082128。
国际注册报告标识符（IRRID）：PRR1-10.2196/55252。
