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Trial registered on ANZCTR


Registration number
ACTRN12625000110482p
Ethics application status
Submitted, not yet approved
Date submitted
16/12/2024
Date registered
31/01/2025
Date last updated
31/01/2025
Date data sharing statement initially provided
31/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of A Digital Psychosocial Module for Reducing Caregiver`s Stress, Depression, Anxiety and Pain in Children with Acute Lymphoblastic Leukaemia (ALL)
Scientific title
The Effectiveness of A Digitized Psychosocial Module for Reducing
Caregiver`s Distress and Pain in Children with Acute Lymphoblastic
Leukaemia (ALL)
Secondary ID [1] 313574 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 336095 0
Anxiety 336096 0
Posttraumatic Stress 336097 0
Pain 336098 0
Caregiver psychological distress 336340 0
Condition category
Condition code
Cancer 332651 332651 0 0
Children's - Leukaemia & Lymphoma
Mental Health 332652 332652 0 0
Depression
Mental Health 332653 332653 0 0
Anxiety
Mental Health 332654 332654 0 0
Other mental health disorders
Anaesthesiology 332655 332655 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a single blinded, parallel arm, clinically randomized trial of a digital psychosocial module based on the cognitive behavioural approach. The URL of the module is underway as the module is still being set up on the web. The module consists of six chapters focusing on needs identification, effective communication, managing thoughts, emotions and behaviour, stress and coping, problem solving and access to resources in Malaysia. The mode of delivery include notes for self-reading and materials that can be downloaded for use. Participants will be randomly divided into one of two groups (intervention vs. control). The control group will go through usual care. At the same time, the intervention group will be given the digital psychosocial module that they can access at their convenience in span of two weeks. For clarity, the module will be completed by caregivers only. The primary researcher will conduct the recruitment, randomization and remote monitoring (participants are contacted via telephone within the first and final 48 hours of the two-week period for progress checking, queries or support) whereas the follow-up data to measure the effectiveness of the intervention will be collected by a blinded secondary researcher. Monitoring of adherence to the intervention will be done via website analytics on insights such as the number of active users and average engagement time per active user.
Intervention code [1] 330168 0
Behaviour
Comparator / control treatment
The controlled group will receive the usual care. Usual care, in this study refers to, the absence of any additional psychosocial intervention. This is because in a usual setting, caregivers do not receive additional intervention when they accompany their child for follow-up at the hospital. In the absence of an intervention or specific procedure undertaken by the caregivers, there is no activity description on usual care other than the absence of additional support.
Control group
Active

Outcomes
Primary outcome [1] 340166 0
Posttraumatic Stress
Timepoint [1] 340166 0
Baseline, two weeks from baseline and one month after first follow-up
Primary outcome [2] 340167 0
Depression
Timepoint [2] 340167 0
Baseline, two weeks from baseline and one month after first follow-up
Primary outcome [3] 340168 0
Anxiety
Timepoint [3] 340168 0
Baseline, two weeks from baseline and one month after first follow-up
Secondary outcome [1] 443069 0
Child's self-rated pain score (based on either recall of the most recent procedure or during a scheduled procedure within a similar timeframe of data collection)
Timepoint [1] 443069 0
Baseline, two weeks from baseline and one month after first follow-up

Eligibility
Key inclusion criteria
Caregiver
i. The person who spends a majority of their time caring for the child, often known as the primary/secondary caregiver (not limited to biological parents).
ii. Literate in English or Bahasa Melayu.

Child
i. Children aged 4 to 12 years old, diagnosed with Acute Lymphoblastic Leukaemia who are currently in the treatment phase. The Paediatric Pain Management Guideline states that children can reliably report pain
at 4 years old (MOH, 2023).
ii. Scheduled to undergo painful procedures.
iii. Literate in English or Bahasa Melayu.

Note: The sampling criteria must be met by the pair of caregiver-child dyad.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Caregiver
i. Caregivers who have a known mental health condition and/or undergoing psychological intervention or psychiatric treatment.

Child
i. Children who are under palliative or hospice care.
ii. Children with a known condition (eg: developmental disorder) that affects accurate reporting of pain score.

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)
Sequentially Numbered Opaque Sealed Envelope (SNOSE)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
10/04/2026
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 26788 0
Malaysia
State/province [1] 26788 0

Funding & Sponsors
Funding source category [1] 318039 0
University
Name [1] 318039 0
Universiti Kebangsaan Malaysia
Country [1] 318039 0
Malaysia
Primary sponsor type
Individual
Name
Agnes Chong Shu Sze
Address
Country
Malaysia
Secondary sponsor category [1] 320384 0
None
Name [1] 320384 0
Address [1] 320384 0
Country [1] 320384 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316694 0
Research Ethics Committee, UKM (REC, UKM)
Ethics committee address [1] 316694 0
Ethics committee country [1] 316694 0
Malaysia
Date submitted for ethics approval [1] 316694 0
08/01/2025
Approval date [1] 316694 0
Ethics approval number [1] 316694 0

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

Contacts
Principal investigator
Name 138694 0
Dr Agnes Chong Shu Sze
Address 138694 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, WPKL
Country 138694 0
Malaysia
Phone 138694 0
+603 92898121
Fax 138694 0
Email 138694 0
agnes@ukm.edu.my
Contact person for public queries
Name 138695 0
Agnes Chong Shu Sze
Address 138695 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, WPKL
Country 138695 0
Malaysia
Phone 138695 0
+603 92898121
Fax 138695 0
Email 138695 0
agnes@ukm.edu.my
Contact person for scientific queries
Name 138696 0
Agnes Chong Shu Sze
Address 138696 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, WPKL
Country 138696 0
Malaysia
Phone 138696 0
+603 92898121
Fax 138696 0
Email 138696 0
agnes@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.