背景:高达70%的被诊断患有上消化道(GI)或肝胆胆(HPB)癌症的人生活质量(QoL)大幅下降,包括高痛苦水平,疼痛,疲劳,睡眠障碍,减肥和吞咽困难。对于患有上消化道或HPB癌症的成年人,很少有倡导团体和支持系统(即胰腺,肝脏,胃,胆管和食道)及其看护者,在线支持性护理计划可能是支持该患者组和护理人员的另一种具有成本效益的机制.iCare是一个自我导向的,互动式,提供信息的在线程序,资源,以及从病情治疗阶段开始向患者及其护理人员提供的心理套餐。iCare的诞生和发展是由消费者推动的,倡导团体,政府和卫生专业人员。这项研究的目的是确定iCare的可行性和可接受性,在入学后3个月和6个月检查与健康相关的QoL和照顾者负担的初步疗效,以及iCare的潜在成本效益,从健康和社会的角度来看,对于患者和看护者来说。
方法:一项II期随机对照试验。总的来说,新诊断为上消化道或HPB癌症的162人将通过上消化道癌症登记处招募,在线广告,或医院诊所。患者和护理人员将被随机分配(1:1)到iCare计划或常规护理。参与者评估将在注册时进行,三个月和六个月后。主要结果是i)可行性,按资格衡量,招募,反应和流失率,和ii)可接受性,按与iCare的参与度衡量(登录频率,使用iCare所花费的时间,以及在干预期内使用功能)。次要结果是患者的QoL变化和未满足的需求,和照顾者的负担,未满足的需求和QoL。将拟合线性混合模型以获得次要结果的疗效和变异性的初步估计。经济分析将包括成本后果分析,将所有结果与成本进行比较。
结论:iCare提供了一种潜在的支持性护理模式来改善QoL,上消化道或HPB癌症患者及其照顾者未满足的需求和疾病负担。
■ACTRN12623001185651。该协议反映了2023年4月26日的版本#1。
BACKGROUND: Up to 70% of people diagnosed with upper gastrointestinal (GI) tract or hepato-pancreato-biliary (HPB) cancers experience substantial reductions in quality of life (QoL), including high distress levels, pain, fatigue, sleep disturbances, weight loss and difficulty swallowing. With few advocacy groups and support systems for adults with upper GI or HPB cancers (i.e. pancreas, liver, stomach, bile duct and oesophageal) and their carers, online supportive care programs may represent an alternate cost-effective mechanism to support this patient group and carers. iCare is a self-directed, interactive, online program that provides information, resources, and psychological packages to patients and their carers from the treatment phase of their condition. The inception and development of iCare has been driven by consumers, advocacy groups, government and health professionals. The aims of this
study are to determine the feasibility and acceptability of iCare, examine preliminary efficacy on health-related QoL and carer burden at 3- and 6-months post enrolment, and the potential cost-effectiveness of iCare, from health and societal perspectives, for both patients and carers.
METHODS: A Phase II randomised controlled
trial. Overall, 162 people with newly diagnosed upper GI or HPB cancers and 162 carers will be recruited via the Upper GI Cancer Registry, online advertisements, or hospital clinics. Patients and carers will be randomly allocated (1:1) to the iCare program or usual care. Participant assessments will be at enrolment, 3- and 6-months later. The primary outcomes are i) feasibility, measured by eligibility, recruitment, response and attrition rates, and ii) acceptability, measured by engagement with iCare (frequency of logins, time spent using iCare, and use of features over the intervention period). Secondary outcomes are patient changes in QoL and unmet needs, and carer burden, unmet needs and QoL. Linear mixed models will be fitted to obtain preliminary estimates of efficacy and variability for secondary outcomes. The economic analysis will include a cost-consequences analysis where all outcomes will be compared with costs.
CONCLUSIONS: iCare provides a potential model of supportive care to improve QoL, unmet needs and burden of disease among people living with upper GI or HPB cancers and their carers.
UNASSIGNED: ACTRN12623001185651. This protocol reflects Version #1 26 April 2023.