Improving the Wellbeing of People With Advanced Cancer and Their Family Carers: An Effectiveness Implementation Trial of an Australian Dyadic Digital Health Intervention (FOCUSau)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 433
- 试验地点
- 10
- 主要终点
- Change in self-efficacy
研究概览
简要总结
FOCUS is a dyadic, psychoeducational intervention developed in the USA, shown to improve the wellbeing and quality of life (QoL) of patients with advanced cancer and their primary family carers. The intervention consists of five core components underpinning the FOCUS acronym:
(F) supporting Family involvement, (O) supporting Outlook and meaning, (C) increasing Coping effectiveness, (U) reducing Uncertainty, and (S) Symptom management. Originally a nurse-delivered in-person intervention, FOCUS has been translated into a self-administered web-based intervention as part of an European study.
The overall aim of this project is to determine the effectiveness and sustainability of a digital health intervention (FOCUSau) aimed at improving the wellbeing and self-efficacy of patients with advanced cancer and their primary support person/carer.
A primary support person/carer is an unpaid individual identified by the person with advanced cancer (not necessarily a partner or family member) who is providing them with physical, social or emotional support. Hereafter referred to as a "carer". The term "dyad" refers to the patient and primary support person/carer.
The project objectives are:
- adapt FOCUS to the Australian context and develop FOCUSau;
- examine the effectiveness of FOCUSau in improving the wellbeing (primary outcomes: QoL and self-efficacy) of patients with advanced cancer and their primary family carer;
- compare the type and costs of health service use by participants in the intervention and control group; and
- assess the acceptability, feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system.
A pragmatic phase III hybrid effectiveness-implementation trial with an integrated research design that includes digital health evaluation will be used in patients with advanced cancer and their primary support person/carer.
Data will be collected three times from patient-carer dyads:
- at baseline (T0) after which the dyad will immediately be randomised to one of the study arms,
- first follow-up at 12 weeks after baseline (T1) and,
- second follow-up at 24 weeks after baseline (T2).
详细描述
STUDY SETTING:
The patient-carer dyads will be recruited via two methods: (1) referral from hospitals or (2) self-referral. For method one, approximately six hospitals and/or cancer centres (metropolitan and regional) across Australia will be selected. For the self-referral recruitment method, patients who have been made aware of the project (but have not been officially screened by a clinician) may self-refer via a webform on the project website. These patients will be made aware via consumer/carer/cancer advocacy groups, or social media advertisement.
SAMPLE SIZE:
A pre-determined strict fixed sequence (FS) procedure defines prospectively hierarchical ordering of the primary endpoints; emotional wellbeing (1) and self-efficacy (2). Testing of null hypotheses proceeds according to their hierarchical order; that is, hypothesis 1 (H(1)0) is tested first at a significance level of 5%, and if H(1)0 is rejected then hypothesis 2 (H(2)0) is tested at the same significance level, otherwise H(2)0 is not tested at all. The strict FS approach has the highest power for testing the first hypothesis (outcome: emotional wellbeing) compared to the other methods, as it does not save any portion of alpha for testing later hypothesis. The reference mean value from The European Organization for Research and Treatment of Cancer (EORTC) for all cancer patients, stage III-IV is 71.5 (SD: 23.8). To maintain rigorous control over Type I errors due to multiple comparisons, the alpha level is set at 0.025 instead of the more common 0.05. This adjustment accounts for the multiple comparisons required in the study, including comparisons between a control group and two participant groups (patients and carers). Statistical power is set at 0.80. The expected difference between the control group and the intervention arm in the primary outcomes is 0.375 SD at T1 (12 weeks). With these parameters n=173 dyads are needed in each arm (i.e. 346 dyads in total). Anticipating a maximum 80% retention rate at T1 (USA FOCUS retention was 86%) approximately 433 dyads will need to be recruited. An enrolment rate of 55% of those eligible was achieved in prior digital health FOCUS study from 2014, however it is anticipated this will be higher for FOCUSau (estimating 70%) given the internet is much more widely available now and the digital recruitment approach; meaning that approximately 618 dyads who meet eligibility criteria will need to be identified. Evidence also suggests that recruitment rates can increase when a digital health intervention is offered.
DATA ANALYSIS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the intervention the dyads cannot be blinded to allocation. The research nurse/officers involved in the consenting process will not be blinded as they will facilitate the second videoconference to inform the dyads about their allocated group (intervention or control). As data collection will occur electronically (via the FOCUSau platform) the research team will be blinded to which trial group the dyads were randomised to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced cancer
- •Over 18 years of age
- •Able to comprehend written or spoken English
- •No visual, hearing, and/or cognitive impairment that would preclude participation
- •Able to commit to research participation requirements (including data collection and completion of the FOCUSau intervention if randomised to that group)
- •Able to access the internet (on desktop computer, laptop computer or tablet device)
- •Able to identify a primary support person/carer, who is an unpaid individual (not necessarily a partner or family member) who is providing physical, social or emotional support.
排除标准
- •Involvement in an advanced cancer non-drug trial that focuses on improving QoL
- •Family carer Inclusion Criteria:
- •Identified by the patient as their primary support person who is related to them biologically, legally or emotionally, and is willing to accept this support role
- •Aged over 18 years
- •No visual, hearing, and/or cognitive impairment that would preclude participation
- •Able to commit to research participation requirements
- •Able to access the internet
- •Dyad Inclusion Criteria:
- •Capacity to effectively utilise the internet (as determined through a short practical online exercise as part of the screening and consent process).
结局指标
主要结局
Change in self-efficacy
时间窗: T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
For patients and for carers: The Lewis´ Cancer self-efficacy scale
Change in emotional wellbeing
时间窗: T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
For patients and for carers: The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) 10 emotional function items
次要结局
- Change in patient quality of life(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in coping(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in appraisal of illness(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in ways of giving support(T0 (baseline) T1 (12 weeks) T2 (24 weeks))
- Change in carer quality of life(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in patient social wellbeing(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in patient overall health(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in dyadic coping(T0 (baseline) T1 (12 weeks) T2 (24 weeks))
- Change in patient social functioning(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in utilisation of healthcare and associated services(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Change in quality-adjusted life years(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))
- Patient level of functioning(T0 (baseline), T1 (12 weeks) and T2 (24 weeks))