Trial Title:
FOCUSau: A Dyadic Digital Health Intervention to Improve the Wellbeing of People With Advanced Cancer and Their Carers
NCT ID:
NCT06082128
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Palliative care
End-of-life decision making
Supportive care
Psychoeducational intervention
Dyadic
Family caregiver
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
FOCUSau
Description:
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.
Arm group label:
FOCUSau
Other name:
Family involvement(F),Supporting outlook and meaning(O),Increasing Coping Effectiveness(C),Reducing Uncertainty(U),Symptom Management(S)
Other name:
FOCUSau (web-based intervention)
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).
Detailed description:
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:
The effectiveness of FOCUSau will be compared with the standard care (control group) for
each participant population (patients/carers) using significance level of alpha=0.025.
The hypotheses will be tested using a mixed model (per participant population) with the
T1 measurement values for emotional wellbeing and self-efficacy as primary outcomes.
These mixed models will be implemented using International Business Machines Corporation
(IBM) Statistical Package for the Social Sciences (SPSS) for Windows Version 27.0 and R
with recruitment centre treated as a random effect and randomisation group as predictor
variables. As per the fixed sequence (FS) procedure, the null hypotheses of the second
primary endpoint (self-efficacy) will only be tested if a significant result is found for
the first primary endpoint (emotional wellbeing). Additionally, other factors identified
in the literature will be incorporated as potentially predictive by including them as
covariates in the mixed models. Analyses on both 'intention-to-treat' and per-protocol
principles will be performed. To interpret the magnitude of the effects for the different
outcomes, effect sizes will be estimated (Cohen's d).
The data analysis will encompass all primary and secondary outcomes. Primary endpoints,
including emotional wellbeing and self-efficacy measured at T1, will be analysed first.
Following that, secondary endpoints, comprising outcomes measured at T1 that are not
primary endpoints, as well as all outcomes measured at T2 (occurring 24 weeks from T0),
will be assessed. This approach allows for a comprehensive evaluation, including the
examination of longer-term effects.
The robustness and validity of the results will be explored using sensitivity analyses by
varying the parameter inputs (including sensitivity to the use of values for missing
observations). The analysis will be conducted for the within trial period; the potential
to extrapolate results over the longer-term will be assessed based on the proportion of
patients alive at the end of follow-up.
The cost-effectiveness analysis will be reported as the mean costs of care per dyad in
each arm of the study. Costs applied to health care service use will be as per Australian
standard fees (e.g., via the Medicare Benefits Schedule). If a difference in outcomes is
observed, as hypothesised, the incremental cost effectiveness of FOCUSau compared with
control will be estimated in terms of the: (1) cost per additional patient with a
meaningful improvement in emotional wellbeing (as assessed using the EORTC QLQ-C30
emotional wellbeing scale); and separately, (2) cost per additional carer with a
meaningful change in self-efficacy (as assessed using the The Lewis´ Cancer self-efficacy
scale). The base case analysis of cost-effectiveness will be conducted from a health care
system perspective. Subsequent sensitivity analyses will modify the assessment of costs
to adopt a societal perspective to capture the impact of informal care costs, as well as
testing the robustness of the analysis results to variations in other parameter inputs.
Missing data for costs and outcomes will be described and summarised. Where missing data
can be regarded as missing at random, likelihood (interpolation) methods will be used for
analysis of those data as appropriate.
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Calvary Healthcare Kogarah
Address:
City:
Kogarah
Zip:
2217
Country:
Australia
Contact:
Last name:
Caitlin Sheehan
Phone:
0295533179
Email:
caitlin.sheehan@health.nsw.gov.au
Investigator:
Last name:
Caitlin Sheehan, Dr
Email:
Principal Investigator
Facility:
Name:
Mater Health Service
Address:
City:
Kangaroo Point
Zip:
4169
Country:
Australia
Contact:
Last name:
Karyn Foster
Phone:
0731633884
Email:
karyn.foster@mater.org.au
Investigator:
Last name:
Phillip Good, Prof
Email:
Principal Investigator
Facility:
Name:
Northern Adelaide Palliative Service
Address:
City:
Modbury
Zip:
5092
Country:
Australia
Contact:
Last name:
Kerri Grant
Phone:
0406181984
Email:
kerri.grant@sa.gov.au
Investigator:
Last name:
Kerri Grant
Email:
Principal Investigator
Facility:
Name:
Barwoon Health Mckellar Centre
Address:
City:
Geelong
Zip:
3215
Country:
Australia
Contact:
Last name:
Anna Dowd
Phone:
0342155700
Email:
anna.dowd@barwoonhealth.org.au
Investigator:
Last name:
Peter Eastman
Email:
Principal Investigator
Facility:
Name:
St Vincents Hospital
Address:
City:
Melbourne
Zip:
3010
Country:
Australia
Contact:
Last name:
Jennifer Weil
Email:
jennifer.weil@svha.org.au
Investigator:
Last name:
Peter Hudson, Prof
Email:
Principal Investigator
Start date:
December 2023
Completion date:
August 2025
Lead sponsor:
Agency:
University of Melbourne
Agency class:
Other
Collaborator:
Agency:
St Vincent's Hospital Melbourne
Agency class:
Other
Collaborator:
Agency:
University of Technology, Sydney
Agency class:
Other
Collaborator:
Agency:
National Health and Medical Research Council, Australia
Agency class:
Other
Collaborator:
Agency:
University of Sydney
Agency class:
Other
Collaborator:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Collaborator:
Agency:
Vrije Universiteit Brussel
Agency class:
Other
Collaborator:
Agency:
Flinders University
Agency class:
Other
Collaborator:
Agency:
Queensland University of Technology
Agency class:
Other
Collaborator:
Agency:
University of Michigan
Agency class:
Other
Source:
University of Melbourne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082128
