Clinical trial · Interventional
FOCUSau: A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers
Improving the Wellbeing of People With Advanced Cancer and Their Family Carers: An Effectiveness Implementation Trial of an Australian Dyadic Digital Health Intervention (FOCUSau)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 1. adapt FOCUS to the Australian context and develop FOCUSau; 2. 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; 3. compare the type and costs of health service use by participants in the intervention and control group; and 4. 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: 1. at baseline (T0) after which the dyad will immediately be randomised to one of the study arms, 2. first follow-up at 12 weeks after baseline (T1) and, 3. second follow-up at 24 weeks after baseline (T2).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOCUSau | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Dyads in the control group will receive usual care only. Usual advanced cancer care is known to be heterogeneous. It is expected usual care to include care from specialists, doctors, nurses or other health care professionals that patients usually engage with.
- type
- EXPERIMENTAL
- label
- FOCUSau
- description
- Dyads in the FOCUSau arm will receive the web-based FOCUSau program in addition to usual care.
- interventionNames
- Behavioral: FOCUSau
Primary outcomes (2)
- measure
- Change in emotional wellbeing
- timeFrame
- T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient Inclusion Criteria: * 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. Patient Exclusion Criteria: \- 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).
References
Publications (1)
- DERIVEDHudson 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. 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). JMIR Res Protoc. 2024 Aug 13;13:e55252. doi: 10.2196/55252. PMID 39137414