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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
Date last updated
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
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)
Secondary ID [1] 0 0
APP2006170
Secondary ID [2] 0 0
84479
Universal Trial Number (UTN)
Trial acronym
FOCUSau
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in emotional wellbeing
Timepoint [1] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Primary outcome [2] 0 0
Change in self-efficacy
Timepoint [2] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [1] 0 0
Change in patient quality of life
Timepoint [1] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [2] 0 0
Change in carer quality of life
Timepoint [2] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [3] 0 0
Change in patient social wellbeing
Timepoint [3] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [4] 0 0
Change in patient social functioning
Timepoint [4] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [5] 0 0
Change in patient overall health
Timepoint [5] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [6] 0 0
Change in appraisal of illness
Timepoint [6] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [7] 0 0
Change in coping
Timepoint [7] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [8] 0 0
Change in ways of giving support
Timepoint [8] 0 0
T0 (baseline) T1 (12 weeks) T2 (24 weeks)
Secondary outcome [9] 0 0
Change in dyadic coping
Timepoint [9] 0 0
T0 (baseline) T1 (12 weeks) T2 (24 weeks)
Secondary outcome [10] 0 0
Patient level of functioning
Timepoint [10] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [11] 0 0
Change in utilisation of healthcare and associated services
Timepoint [11] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)
Secondary outcome [12] 0 0
Change in quality-adjusted life years
Timepoint [12] 0 0
T0 (baseline), T1 (12 weeks) and T2 (24 weeks)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
433
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Healthcare Kogarah - Kogarah
Recruitment hospital [2] 0 0
Mater Health Service - Kangaroo Point
Recruitment hospital [3] 0 0
Northern Adelaide Palliative Service - Modbury
Recruitment hospital [4] 0 0
Barwoon Health Mckellar Centre - Geelong
Recruitment hospital [5] 0 0
St Vincents Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4169 - Kangaroo Point
Recruitment postcode(s) [3] 0 0
5092 - Modbury
Recruitment postcode(s) [4] 0 0
3215 - Geelong
Recruitment postcode(s) [5] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Technology, Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Sydney
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Peter MacCallum Cancer Centre, Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Vrije Universiteit Brussel
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Flinders University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Queensland University of Technology
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
University of Michigan
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT06082128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Hudson, PhD
Address 0 0
The University of Melbourne and St Vincents Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shaira Baptista, PhD
Address 0 0
Country 0 0
Phone 0 0
+61394160000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06082128