Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001185651
Ethics application status
Approved
Date submitted
24/08/2023
Date registered
16/11/2023
Date last updated
19/11/2023
Date data sharing statement initially provided
16/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
iCare - a self-directed, interactive online program for people living with upper gastrointestinal or hepato-pancreato-biliary cancers and their carers
Scientific title
iCare – A self-directed, interactive online program to improve health and wellbeing for people living with upper gastrointestinal or hepato-pancreato-biliary cancers, and their informal carers: a Phase II randomised controlled trial
Secondary ID [1] 310456 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 331247 0
Liver cancer 331248 0
Bile duct cancer 331249 0
Pancreatic cancer 331250 0
Stomach cancer 331251 0
Condition category
Condition code
Cancer 328006 328006 0 0
Biliary tree (gall bladder and bile duct)
Cancer 328007 328007 0 0
Liver
Cancer 328008 328008 0 0
Oesophageal (gullet)
Cancer 328009 328009 0 0
Stomach
Cancer 328010 328010 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The iCare program comprises two system pathways (patient or carer). The relevant pathway will be identified at login stage. Similar to our previous work, the pathways will provide information, support and resources with a facility to identify and record medical symptoms.

Participants will have access to an interactive program, organised around 10 modules, with versions for patients diagnosed with upper GI cancers and their carers. Each time a patient accesses the portal, they provide information on their current physical needs and an algorithm directs them to relevant information on the website. iCare provides a system for triaging patient symptoms, with patients receiving recommended management strategies and carers alerted to patient symptoms and recommendations for follow up. Following on from our previous research, participants reporting, and carers observing, severe symptoms, will receive tailored information about when to seek medical assistance.

The modules in iCare are organised into broad topic such as cancer information, nutrition, exercise, wellbeing, survivorship etc. These topics have been developed in our previous research with patient and carer consumers. Within each module is a compilation of relevant existing resources provided by evidence-based organisations; including; videos, podcasts and written information. The program is fully flexible allowing participants to seek information from the modules most relevant to their needs over the 3-month intervention period. Participants can access the modules as many times as they like. There is no prescribed amount of time needed to use each module, participants can spend the amount of time desired locating resources and reading information to meet their needs.
Using embedded tracking software, we will observe natural use of the program over 3-months by collecting frequent and number of logins and duration of use.

Based on the findings of our previous work, a medical symptom tracking calendar and carer emotional states, will be incorporated to enhance carers’ ability to monitor patient medical symptoms and their own emotional response. Patients and carers will receive an email message each week that will direct them to resources available within the portal; this approach has been successfully trialled by our team.
Intervention code [1] 326855 0
Behaviour
Intervention code [2] 326856 0
Lifestyle
Comparator / control treatment
Participants will receive, at baseline, information about support, including recommendations to use services, such as Pancare Foundation and the Cancer Council Victoria (CCV) cancer support line. At the end of the data collection period (6 months post baseline), participants will be offered access to iCare for their ongoing use.
Control group
Active

Outcomes
Primary outcome [1] 335870 0
Feasibility and acceptability: will include system use data (eg usage patterns, log-in, pages viewed, amount of time spent per visit, number of days between first and last long-in, intervention dose, downloads, click-through and searching for information; use of ACT, mindfulness, symptom management and alerts, adherence rates), for both patients and carers, overall uptake of iCare and use over time. This will include summarising the Google analytic reports in the intervention group to determine engagement.
Timepoint [1] 335870 0
3-months post baseline
Secondary outcome [1] 425939 0
Quality of life (patients)
Functional Assessment of Cancer Therapy (FACT-G) is a 27-item questionnaire, designed to measure four domains of quality of life in people living with cancer and valid for all cancer types.

Timepoint [1] 425939 0
3 and 6-months post baseline
Secondary outcome [2] 428558 0
Unmet needs (patients)
Supportive Care Needs Survey (SCNS) Patient participants will report on their experience on physical, social/family, emotional, and functional well-being. Patients will also report on their unmet needs and emergency department attendance and hospital admissions during the previous 3 months
Timepoint [2] 428558 0
3 and 6-months post baseline
Secondary outcome [3] 428559 0
Unmet needs (carers):
Partner and Caregiver Supportive Care Needs Survey (SCNS-P&C) will measure unmet supportive care needs and includes subscales of psychological, emotional, work, social and information needs.
Timepoint [3] 428559 0
3 and 6-months post baseline
Secondary outcome [4] 428560 0
Quality of Life (carers):
Caregiver Quality of Life Index-Cancer (CQOLC) scale measures quality of life and provides information about physical, social, emotional and financial wellbeing. It comprises 35 questions, has internal consistency, validity and reliability and has been used in technology-based intervention trials.
Timepoint [4] 428560 0
3 and 6-months post baseline
Secondary outcome [5] 428563 0
Cost-effectiveness:
We will apply the Assessment of Quality of Life – four Dimension(AQoL4D) for both patient and carer dyads; quality-adjusted life years (QALYs) are the preferred outcome metric of economic evaluations as they allow practical ‘value-for-money’ judgements to be made. We will record use of the program over the intervention period and beyond, via both automated website analytics and self-report.
Timepoint [5] 428563 0
3 and 6-months post baseline
Secondary outcome [6] 428564 0
Resource use and costs will be measured via self-report hospitalisation (including emergency department; admissions). As these data do not capture all resource use, a questionnaire to assess patients’ use of medical resources, will also be included to capture broader resource use, and successfully used by our team in other cancer-related studies. The resources use questionnaire has been used in our previous work.
Timepoint [6] 428564 0
3 and 6-months post baseline
Secondary outcome [7] 428565 0
Burden (carers):
Zarit Burden Interview-12 (ZBI-12)scale, a reliable and valid measure of carer burden, similar to the standard ZBI (22 questions). The ZBI has been used across a variety of cancer types as well as across different stages of disease.
Timepoint [7] 428565 0
3 and 6-months post baseline

Eligibility
Key inclusion criteria
Inclusion criteria:
• aged 18+ years old
• people newly diagnosed with upper GI cancers within previous 3 months (pancreas, liver, stomach, bile ducts and oesophagus cancers)
• treated with a six month prognosis
• registered with the Upper Gastro-Intestinal Cancer Registry
• carers of someone with these cancers
• able to speak and read English
• own a web-based device, such as a smartphone, Android, iPad, desktop computer or other internet connected device
Carers will be identified through eligible patients as the person most involved in their day-to-day care and medical appointments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English language skills to understand content presented in English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence will be embedded in Qualtrics. Only the project manager will have access to group allocation. Other investigators and statisticians will be blinded to group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All statistical analysis will be conducted on an intention-to-treat basis, i.e. all randomized participants with at least one post-baseline measurement will be analysed by original treatment assignment, regardless of adherence. Baseline characteristics will be described and compared between groups using summary measures and tests selected based on variable distribution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
384
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314664 0
Government body
Name [1] 314664 0
Medical Research Future Fund (MRFF) Clinical Trials Activity
Country [1] 314664 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap StreetGeelongVictoria3220
Country
Australia
Secondary sponsor category [1] 316630 0
None
Name [1] 316630 0
n/a
Address [1] 316630 0
n/a
Country [1] 316630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313683 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313683 0
Ethics committee country [1] 313683 0
Australia
Date submitted for ethics approval [1] 313683 0
29/05/2023
Approval date [1] 313683 0
27/07/2023
Ethics approval number [1] 313683 0
2023-171

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128998 0
Prof Patricia Livingston
Address 128998 0
Deakin University1 Gheringhap StreetGeelongVictoria3220
Country 128998 0
Australia
Phone 128998 0
+61 392446609
Fax 128998 0
Email 128998 0
[email protected]
Contact person for public queries
Name 128999 0
Natalie Winter
Address 128999 0
Deakin University1 Gheringhap StreetGeelongVictoria3220
Country 128999 0
Australia
Phone 128999 0
+61 39246 8225
Fax 128999 0
Email 128999 0
[email protected]
Contact person for scientific queries
Name 129000 0
Natalie Winter
Address 129000 0
Deakin University1 Gheringhap StreetGeelongVictoria3220
Country 129000 0
Australia
Phone 129000 0
+61 39246 8225
Fax 129000 0
Email 129000 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified datasets will be provided for primary and secondary outcomes
When will data be available (start and end dates)?
Upon request.
Data will be available following publication of the main results paper and will be available for five years.
Available to whom?
Datasets will be provided to researchers who provide reasonable written request.
Available for what types of analyses?
Datasets will be made available for secondary analyses.
How or where can data be obtained?
Written request can be submitted to the project manager. Please contact Dr Natalie Winter at [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseiCare - a self-directed, interactive online program to improve health and wellbeing for people living with upper gastrointestinal or hepato-pancreato-biliary cancers, and their informal carers: the study protocol for a Phase II randomised controlled trial.2024https://dx.doi.org/10.1186/s12885-024-11861-2
N.B. These documents automatically identified may not have been verified by the study sponsor.