Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001341617
Ethics application status
Approved
Date submitted
14/11/2023
Date registered
19/12/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
CarersCanADAPT: Evaluation of an online cognitive behavioural therapy (iCBT) program for cancer carers
Scientific title
Evaluation of the CarersCanADAPT iCBT program for cancer carers with anxiety and depression: Hybrid type 1 effectiveness-implementation trial
Secondary ID [1] 310650 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer carers 331531 0
Anxiety 331532 0
Depression 331533 0
Carer burden 332194 0
Condition category
Condition code
Cancer 328271 328271 0 0
Any cancer
Mental Health 328272 328272 0 0
Anxiety
Mental Health 328273 328273 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials: Online therapeutic iCBT intervention (CarersCanADAPT) will be delivered via a secure web based program to study participants over a 6 week period. Each section will take 1-2 hours to complete. The lesson topics are:
Lesson 1: Learning about depression and anxiety
Lesson 2: Identifying and tackling thoughts
Lesson 3: Tackling unhelpful behaviours
Lesson 4: Helpful coping
Lesson 5: Adjusting to change, communication, and support
Lesson 6: Staying well in the long term and getting even better
Website back-end analytics will be used to monitor adherence to the intervention - data will be captured on number of log-ins, date of log-ins, time spent on each section, and interaction with activities, e.g. downloading worksheets and summaries.

Procedures: Participants in the RCT will be randomly assigned to the intervention or wait list control condition, 1:1 allocation ratio.
The randomisation will be electronically generated using an access database.
Participants in the intervention (iCBT) condition will receive immediate access to CarersCanADAPT iCBT via the secure CarersCanADAPT Portal and will complete 1 lesson per week over 6 weeks, and then complete follow-up measures immediately post intervention and 8 weeks later (i.e. 14 weeks).
Participants in the wait list control condition will not be provided with the CarersCanADAPT iCBT and will complete measures only. After the wait list control group has completed 14 weeks on the wait list, they will receive access to the CarersCanDAPT iCBT and will continue to complete measures for the duration of the intervention and follow-up period.
Additionally, Participants will complete the PHQ-9 and GAD-7 as part of the pre-lesson screening/monitoring measure every 2 weeks during the intervention phase

Delivery: The intervention will be delivered by the research team, who will send participants a link to access the web-platform which contains structured lessons and activities, supported by multimedia storylines. The intervention will be delivered online. Participants may complete the intervention anywhere they chose where they have access to a device which connects to the internet. There will be six lessons for individuals to work through at their own pace. One lesson will be made available weekly to participants, who will be sent an email reminder when a new lesson becomes available.
Participants who have not completed the training will be sent up to 3 reminder emails from the research team to encourage completion.
Intervention code [1] 327054 0
Treatment: Other
Intervention code [2] 327510 0
Behaviour
Comparator / control treatment
There will be one waitlist control group in the trial that will receive routine care, while they wait 14 weeks to access the intervention. After 14 weeks the control group will complete the intervention.

Carers in the waitlist control condition who receive routine care will be provided with general information and support via referral to the “Caring for Someone with Cancer” resources provided by the Cancer Council NSW. In addition, carers will be provided with referral to the Australian Government Carers Gateway website and will receive a brief factsheet on the services that Carers Gateway provides.
Control group
Active

Outcomes
Primary outcome [1] 336131 0
Depression (measured using PHQ-9)
Timepoint [1] 336131 0
Difference in carer depression (PHQ-9 scores) of intervention group at 6 and 14 weeks’ post baseline time point compared to depression measures of waitlist control group at 6 and 14 weeks.
Primary outcome [2] 336717 0
Carer Anxiety ( measured using GAD-7)
Timepoint [2] 336717 0
Difference in carer anxiety (GAD-7 scores) of intervention group at 6 and 14 weeks’ post baseline time point compared to anxiety measures of waitlist control group at 6 and 14 weeks.
Secondary outcome [1] 426960 0
Carer burden: measured using the 22-item Carer Burden Scale
Timepoint [1] 426960 0
Difference in carer burden (measured using the Carer Burden Scale) of intervention group at 6 and 14 weeks’ post baseline time point compared to carer burden measures of waitlist control group at 6 and 14 weeks.
Secondary outcome [2] 429421 0
Acceptability of iCBT module assessed with optional post-intervention qualitative interview. Interviews are expected to last approximately 30 minutes and will be conducted one-on-one over the phone, zoom or in person. Interviews will be guided by an interview schedule of open-ended questions about participant's experiences using the module and their feedback on the module content. All interviews will be audio recorded and transcribed verbatim.
Timepoint [2] 429421 0
6 weeks post-intervention (optional qualitative interview)

Eligibility
Key inclusion criteria
Australian carers of people with cancer with elevated levels of distress will be included in the main trial.
Carers inclusion:
• Elevated levels of distress will be operationalised as a score of 4 or more on the distress thermometer, followed by a score of 5 or more on the PHQ-9 and a score of 5 or more on GAD-7
• Are a person biologically, legally, or emotionally related to an adult person who has ever received a diagnosis of primary cancer or cancer recurrence.
o NB: we have not imposed time limits for when a loved one received a cancer diagnosis (so long as they were 18 years or older at time of diagnosis) as carers may experience depression, anxiety and/or caregiving related stress at any point from diagnosis to many years into survivorship.
• Identifies as a primary carer, providing unpaid support to the cancer patient
• Aged over 18 years
• The person they care for was diagnosed with cancer as an adult (aged >18 years old at time of diagnosis)
• Has sufficient English language skills to complete the intervention and/or questionnaires
• Willing to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

• Insufficient cognitive capacity or English language skills to provide informed consent and complete the intervention and/or questionnaires
• The person with cancer they care for has a life expectancy of less than 12 months
• Actively receiving psychological therapy for carer related distress

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Quantitative Data

To address the aims of this trial, linear mixed effects models will be conducted to examine the differences in anxiety, depression, and stress between intervention and waitlist control groups over each follow-up. The model will be designed with fixed effects (intervention/waitlist control groups) and random effects (individual participants).

Qualitative Data
All participant interviews will be audio recorded and then transcribed verbatim. The researchers will thematically analyse the data using the Framework Methods approach.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314773 0
Government body
Name [1] 314773 0
Cancer Institute NSW
Country [1] 314773 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 316862 0
None
Name [1] 316862 0
Address [1] 316862 0
Country [1] 316862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313783 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313783 0
Level 3, Michael Spence Building (F23) University of Sydney NSW 2006
Ethics committee country [1] 313783 0
Australia
Date submitted for ethics approval [1] 313783 0
13/11/2023
Approval date [1] 313783 0
21/12/2023
Ethics approval number [1] 313783 0
2023/930

Summary
Brief summary
The primary aim of this study is to test the effectiveness of an online Cognitive Behavioural Therapy (iCBT) intervention (called CarersCanADAPT) for carers of people with cancer in reducing symptoms of anxiety and depression compared to carers in the wait list control condition.
Who is it for?
You may be eligible for this study if you are an adult who is a primary carer for an adult diagnosed with cancer.
Study details
Participants will be asked to complete the CarersCanADAPT 6 week online cognitive behavioural therapy program. You will be randomly allocated to join either the immediate access group or the waitlist group. Either way you will receive access to the CarersCanADAPT program, however those people in the waitlist group will get access to the program in 14 weeks’ time.
You will also be asked to complete an online initial (baseline) questionnaire, and 2 more questionnaires at 6 and 14 weeks after beginning the trial. If you are allocated to the waitlist group, you will also be asked to complete an additional 2 questionnaires at 20 and 28 weeks after beginning the trial.
This research offers an opportunity to test the effectiveness and implementation of an evidence-based online support module for carers, which if found to be effective can be broadly disseminated and potentially implemented into routine care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129338 0
Dr Dr Rebekah Laidsaar-Powell
Address 129338 0
Room 310, Level 3, Griffith Taylor Building (A19) Manning Road, The University of Sydney, NSW, 2006
Country 129338 0
Australia
Phone 129338 0
+61402656720
Fax 129338 0
Email 129338 0
rebekah.laidsaar-powell@sydney.edu.au
Contact person for public queries
Name 129339 0
Dr Dr Rebekah Laidsaar-Powell
Address 129339 0
Room 310, Level 3, Griffith Taylor Building (A19) Manning Road, The University of Sydney, NSW, 2006
Country 129339 0
Australia
Phone 129339 0
+61402656720
Fax 129339 0
Email 129339 0
rebekah.laidsaar-powell@sydney.edu.au
Contact person for scientific queries
Name 129340 0
Dr Dr Rebekah Laidsaar-Powell
Address 129340 0
Room 310, Level 3, Griffith Taylor Building (A19) Manning Road, The University of Sydney, NSW, 2006
Country 129340 0
Australia
Phone 129340 0
+61402656720
Fax 129340 0
Email 129340 0
rebekah.laidsaar-powell@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may be potentially re-identifiable and would risk participant privacy


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
No additional documents have been identified.