Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000449437p
Ethics application status
Submitted, not yet approved
Date submitted
11/04/2025
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Carer Conquer Fear (Carer-CF): Piloting an online carer-specific program for fear of cancer recurrence
Scientific title
Piloting Carer Conquer Fear (Carer-CF): Investigating the feasibility and acceptability of an online carer-specific program for fear of cancer recurrence

Secondary ID [1] 314057 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 336805 0
Condition category
Condition code
Cancer 333298 333298 0 0
Any cancer
Mental Health 333299 333299 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Carer Conquer Fear (Carer-CF) is an online contemporary Cognitive Behavioural Therapy intervention delivered via a secure web-based platform. This intervention will be delivered online using a digital story-telling approach to deliver content and includes activities and worksheets. An introductory telephone call will be conducted to assist participants with program access and a mid-way coaching call to facilitate program completion. The online program is divided into 4 lessons, which are completed over a 4-week period ( 1 lesson per week). Each lesson will take around 1 hour to complete. The lesson topics are:
Lesson 1 Learning about fear of cancer recurrence: Information about how to complete the intervention, fear of cancer recurrence and introduction to attention training techniques activity.
Lesson 2 Identifying values: Values clarification activity and goal setting.
Lesson 3 Managing worry: Introduction to different strategies to help manage worry including detached mindfulness and worry postponement and how to practice these.
Lesson 4 Communicating your concerns: Information about communicating with the person you care for and those around you, recognising the worry cycle and a reflection activity to create a new plan for managing worry going forward.

Website analytics will be collected to monitor intervention adherence. This will include number of log-ins, time spent on each lesson, number of lessons completed and worksheet downloads.
Intervention code [1] 330638 0
Treatment: Other
Intervention code [2] 330875 0
Behaviour
Comparator / control treatment
No control group, pre-post study design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340874 0
Intervention feasibility amongst cancer carers
Timepoint [1] 340874 0
3 months after the baseline questionnaires were completed
Primary outcome [2] 340925 0
Intervention acceptability amongst cancer carers
Timepoint [2] 340925 0
3 months after the baseline questionnaires were completed
Secondary outcome [1] 445476 0
Change in carer fear of cancer recurrence scores
Timepoint [1] 445476 0
Baseline, mid-way through the intervention (between Lessons 2 and 3), upon intervention completion and three months post-baseline questionnaires.

Eligibility
Key inclusion criteria
(i) A person biologically, legally, or emotionally related to an adult cancer patient/ survivor who has been diagnosed, or experienced a cancer recurrence in the past 5 years (Note: we will not pose any restriction on patient/ survivor cancer type or stage).
(ii) The person they care for was diagnosed with cancer as an adult (i.e., aged 18 years or older at diagnosis)
(iii) Carer is aged 18 years or older
(iv) Provides unpaid support to the person with cancer
(v) Has sufficient English language skills to complete the intervention and/ or questionnaires
(vi) Has access to the internet
(vii) Willing to participate in the study
(viii) Experiencing FCR (scoring 13 or higher on the FCRI-c severity sub-scale)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Under the age of 18
(ii) Providing care for a child with cancer (i.e., patient/ survivor is under the age of 18 years)
(iii) Bereaved carers
(iv) Caring for a person with a life expectancy of less than 6 months
(v) Carers experiencing severe depression (i.e., scoring 20 or higher on the Patient Health Questionnaire 9-item)
(vi) Actively receiving psychological support for any mental health condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative Data:
Data about intervention feasibility will be collated and reported as percentages. Responses to the study questionnaires assessing feasibility and acceptability will be collated and reported as percentages.

Qualitative Data:
Exit interviews will be audio recorded and transcribed verbatim. Data will then be thematically analysed using a framework approach. The Framework Method first seeks to identify similarities and differences in the data before extracting themes to draw explanations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318563 0
Government body
Name [1] 318563 0
Sydney Cancer Partners
Country [1] 318563 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320962 0
None
Name [1] 320962 0
Address [1] 320962 0
Country [1] 320962 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317163 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317163 0
Ethics committee country [1] 317163 0
Australia
Date submitted for ethics approval [1] 317163 0
19/03/2025
Approval date [1] 317163 0
Ethics approval number [1] 317163 0

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

Contacts
Principal investigator
Name 140214 0
Dr Kyra Webb
Address 140214 0
Room 310, Level 3, Griffith Taylor Building (A19) Manning Road, The University of Sydney, NSW, 2006
Country 140214 0
Australia
Phone 140214 0
+61 2 9351 9638
Fax 140214 0
Email 140214 0
[email protected]
Contact person for public queries
Name 140215 0
Kyra Webb
Address 140215 0
Room 310, Level 3, Griffith Taylor Building (A19) Manning Road, The University of Sydney, NSW, 2006
Country 140215 0
Australia
Phone 140215 0
+61 2 9351 9638
Fax 140215 0
Email 140215 0
[email protected]
Contact person for scientific queries
Name 140216 0
Kyra Webb
Address 140216 0
Room 310, Level 3, Griffith Taylor Building (A19) Manning Road, The University of Sydney, NSW, 2006
Country 140216 0
Australia
Phone 140216 0
+61 2 9351 9638
Fax 140216 0
Email 140216 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data may be re-identifiable, risking 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.