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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06082128
Registration number
NCT06082128
Ethics application status
Date submitted
20/09/2023
Date registered
13/10/2023
Titles & IDs
Public title
FOCUSau: A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers
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Scientific title
Improving the Wellbeing of People With Advanced Cancer and Their Family Carers: An Effectiveness Implementation Trial of an Australian Dyadic Digital Health Intervention (FOCUSau)
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Secondary ID [1]
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APP2006170
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Secondary ID [2]
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84479
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Universal Trial Number (UTN)
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Trial acronym
FOCUSau
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - FOCUSau
No intervention: Usual care - 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.
Experimental: FOCUSau - Dyads in the FOCUSau arm will receive the web-based FOCUSau program in addition to usual care.
BEHAVIORAL: FOCUSau
FOCUSau is a self-administered web-based intervention and completed autonomously via the internet by the dyad. Delivery encompasses the completion of four prescribed consecutive FOCUSau sessions (with three weeks between each session) over a period of 12 weeks.
The sessions are completed simultaneously by the patient and family carer, together at a computer. The intervention sessions can be completed at any time within the 12-week timeframe. Participants receive tailored individual and dyadic messages according to the information provided at study enrollment and their responses to questions within the sessions. Dyads are also provided with an online personal workbook containing the results of interactive exercises completed during the internet sessions. Any information sheets that the dyad indicated as 'of interest to them' during the internet sessions are included as a hyperlink in their personal workbook which also contains evidence-based local advanced cancer related resources.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in emotional wellbeing
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Assessment method [1]
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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
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Timepoint [1]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Primary outcome [2]
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Change in self-efficacy
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Assessment method [2]
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For patients and for carers: The Lewis´ Cancer self-efficacy scale
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Timepoint [2]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [1]
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Change in patient quality of life
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Assessment method [1]
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For patients: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL)
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Timepoint [1]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [2]
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Change in carer quality of life
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Assessment method [2]
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For carers: The Caregiver Quality of Life Index-Cancer (CQOLC)
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Timepoint [2]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [3]
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Change in patient social wellbeing
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Assessment method [3]
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For patients: social wellbeing scale from Functional Assessment of Cancer Therapy - General (FACT-G)
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Timepoint [3]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [4]
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Change in patient social functioning
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Assessment method [4]
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Two social functioning items from The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
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Timepoint [4]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [5]
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Change in patient overall health
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Assessment method [5]
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Two items about overall health from The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
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Timepoint [5]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [6]
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Change in appraisal of illness
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Assessment method [6]
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For patients and for carers: Benefits of Illness Scale
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Timepoint [6]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [7]
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Change in coping
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Assessment method [7]
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For patients and for carers: A shortened version of Brief Cope
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Timepoint [7]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [8]
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Change in ways of giving support
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Assessment method [8]
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For patients and for caregivers: The five items 'Active engagement scale' from the ´Ways of giving support questionnaire´
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Timepoint [8]
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T0 (baseline) T1 (12 weeks) T2 (24 weeks)
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Secondary outcome [9]
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Change in dyadic coping
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Assessment method [9]
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For patients and for caregivers: Three scales from the 'Dyadic Coping Inventory': 'Stress communication by oneself', 'Stress communication by partner' and 'Evaluation of dyadic coping'
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Timepoint [9]
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T0 (baseline) T1 (12 weeks) T2 (24 weeks)
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Secondary outcome [10]
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Patient level of functioning
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Assessment method [10]
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Modified version of Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment
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Timepoint [10]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [11]
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Change in utilisation of healthcare and associated services
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Assessment method [11]
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For patients and for caregivers: Client Service Receipt Inventory (CSRI)
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Timepoint [11]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Secondary outcome [12]
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Change in quality-adjusted life years
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Assessment method [12]
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For patients and for caregivers: EuroQoL EQ-5D-5L
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Timepoint [12]
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T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
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Eligibility
Key inclusion criteria
Patient
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/12/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2025
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Actual
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Sample size
Target
433
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Calvary Healthcare Kogarah - Kogarah
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Recruitment hospital [2]
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Mater Health Service - Kangaroo Point
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Recruitment hospital [3]
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Northern Adelaide Palliative Service - Modbury
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Recruitment hospital [4]
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Barwoon Health Mckellar Centre - Geelong
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Recruitment hospital [5]
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St Vincents Hospital - Melbourne
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4169 - Kangaroo Point
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Recruitment postcode(s) [3]
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5092 - Modbury
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Recruitment postcode(s) [4]
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3215 - Geelong
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Recruitment postcode(s) [5]
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3010 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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St Vincent's Hospital Melbourne
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Technology, Sydney
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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National Health and Medical Research Council, Australia
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Sydney
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Peter MacCallum Cancer Centre, Australia
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Vrije Universiteit Brussel
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Flinders University
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Queensland University of Technology
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Address [8]
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Country [8]
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Other collaborator category [9]
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Other
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Name [9]
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University of Michigan
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Address [9]
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Country [9]
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT06082128
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter Hudson, PhD
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Address
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The University of Melbourne and St Vincents Hospital Melbourne
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Shaira Baptista, PhD
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Address
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Phone
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+61394160000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Results will be published in peer-reviewed, international journals. Local and International conference presentations are anticipated. Opportunities for sharing the study results via media will be sought (e.g., social media platforms such as Twitter).
An option will be provided to participants to receive a plain language summary of the study results. We will use this plain language summary to provide the study results to relevant consumer networks including the Victorian Comprehensive Cancer Centre and Cancer Voices Australia.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06082128