PDF(Pubmed)
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 (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.
BACKGROUND: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128.
UNASSIGNED: PRR1-10.2196/55252.
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.
BACKGROUND: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128.
UNASSIGNED: PRR1-10.2196/55252.
摘要：
背景：晚期癌症显著影响患者和家庭照顾者的生活质量。当患者和护理人员同时作为二元支持时，每个人的幸福都得到了优化。家庭,Outlook,Communication,不确定性,症状管理(FOCUS)是一个二元的，在美国发展的心理教育干预，改善晚期癌症患者及其主要护理人员的健康和生活质量。最初,由护士亲自干预，FOCUS已被改编为自我管理的基于网络的欧洲交付干预。
目的：这项研究的目的是（1）使FOCUS适应澳大利亚环境（FOCUSau）；（2）评估FOCUSau相对于常规护理对照组在改善晚期癌症患者及其主要护理人员的情绪健康和自我效能方面的有效性；（3）比较干预组和对照组之间的医疗保健使用；（4）评估可接受性，可行性,和FOCUSau的可扩展性，以便为将来在澳大利亚医疗保健系统内实施干预措施提供信息。
方法：将在试验开始前调整重点，使用迭代的利益相关者反馈过程来创建FOCUSau。为了检查FOCUSau的功效和成本效益，并评估其可接受性，可行性,和可扩展性，我们将开展一项混合1型实施研究,包括一项3期(临床有效性)试验和一项观察性实施研究.参与者将包括18岁以上的癌症患者，能够访问互联网，并能够确定也可以与参与的主要支持人员或护理人员。样本量由每个臂中的173个二元组组成(即，总共346个二元组合）。将在完成随机化前的基线(T0);基线后12周的第一次随访(T1;N=346);以及基线后24周的第二次随访(T2)时收集患者-护理人员二元数据。
结果：该研究于2022年3月获得资助。2024年7月开始招聘。
结论：如果证明有效，这种干预措施将改善晚期癌症患者及其家庭护理人员的福祉，无论他们的位置或目前的医疗保健支持水平。
背景：ClinicalTrials.govNCT06082128;https://clinicaltrials.gov/study/NCT06082128。
■PRR1-10.2196/55252。
目的：这项研究的目的是（1）使FOCUS适应澳大利亚环境（FOCUSau）；（2）评估FOCUSau相对于常规护理对照组在改善晚期癌症患者及其主要护理人员的情绪健康和自我效能方面的有效性；（3）比较干预组和对照组之间的医疗保健使用；（4）评估可接受性，可行性,和FOCUSau的可扩展性，以便为将来在澳大利亚医疗保健系统内实施干预措施提供信息。
方法：将在试验开始前调整重点，使用迭代的利益相关者反馈过程来创建FOCUSau。为了检查FOCUSau的功效和成本效益，并评估其可接受性，可行性,和可扩展性，我们将开展一项混合1型实施研究,包括一项3期(临床有效性)试验和一项观察性实施研究.参与者将包括18岁以上的癌症患者，能够访问互联网，并能够确定也可以与参与的主要支持人员或护理人员。样本量由每个臂中的173个二元组组成(即，总共346个二元组合）。将在完成随机化前的基线(T0);基线后12周的第一次随访(T1;N=346);以及基线后24周的第二次随访(T2)时收集患者-护理人员二元数据。
结果：该研究于2022年3月获得资助。2024年7月开始招聘。
结论：如果证明有效，这种干预措施将改善晚期癌症患者及其家庭护理人员的福祉，无论他们的位置或目前的医疗保健支持水平。
背景：ClinicalTrials.govNCT06082128;https://clinicaltrials.gov/study/NCT06082128。
■PRR1-10.2196/55252。
