Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001108303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
6/08/2026
Date registered
Help: Date registered
8/09/2026
Date last updated
Help: Date last updated
8/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/09/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Effect of a brief eLearning module on communication skills in cancer carers: A pilot randomised controlled trial
Scientific title
Effect of a brief eLearning module on communication skills in cancer carers: A Pilot randomised controlled trial.
Additional trial identifiers [1] 318063 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
cancer 343151 0
Condition category
Condition code
Cancer 339236 339236 0 0
Any cancer
Public Health 339237 339237 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is a 15-minute eLearning module for informal cancer carers to strengthen communication and advocacy skills when interacting with health providers. The single session 15-minute intervention is asynchronous, and delivered online. The mode of training used were interactive activities with audio and visual informational content. Participants were emailed the link to a baseline survey, after completion of the survey, they were redirected to the online eLearning module. Participants completed the module in their own time and at their own pace.
The platform used indicated participants' progress and completion of the module on the participant's profile. The researchers were able to track participants' progress by accessing participants' profiles.
Intervention code [1] 334989 0
Behaviour
Description of the comparator or control
Care is defined as any support provided to a person diagnosed with cancer. Examples of support can include but are not limited to: personal care, managing appointments, financial support, assistance with transportation.

The control group will not be exposed to any variables, communication training, or intervention provided by the research team. They will continue to provide care in their usual capacities, circumstances. Their interactions with the care recipient's healthcare team will not have been influenced by the intervention during the course of the trial. Their survey responses on perceptions of their interactions and communications with the care recipient's healthcare team will be measured at baseline, 2-weeks post baseline, and 3-months post baseline.

After the final survey, control group carers were emailed a link to access the module.
Control group
Active

Outcomes
Primary outcome [1] 346468 0
communication confidence,
Timepoint [1] 346468 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.
Secondary outcome [1] 465941 0
Health literacy
Timepoint [1] 465941 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.
Secondary outcome [2] 465942 0
Preparedness for caregiving
Timepoint [2] 465942 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.
Secondary outcome [3] 465943 0
Psychological symptoms were assessed using the Depression, Anxiety and Stress Scales-21 (DASS21). The 21-items comprise three subscales that measure depression, anxiety, and stress
Timepoint [3] 465943 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.
Secondary outcome [4] 465944 0
Supported by health providers to understand information
Timepoint [4] 465944 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.
Secondary outcome [5] 465945 0
Active engagement with healthcare providers
Timepoint [5] 465945 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.
Secondary outcome [6] 465946 0
Caregiver burden
Timepoint [6] 465946 0
Participants' survey responses were measured at baseline, 2 weeks post-baseline, and 3 months post-baseline. The intervention group will have been exposed to the intervention at baseline, 2 weeks prior the second survey completed.

Eligibility
Key inclusion criteria
Caregivers will be eligible to participate in the RCT if: they are aged 18+ and are providing support to someone currently receiving treatment for cancer; their care recipient was diagnosed with cancer within the preceding 3 years; they have access to the internet and a digital device and can read and speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
None

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)
Consenting carers will be randomly assigned (1:1) to the intervention or the control group. Stratified sampling will be considered, dividing the subjects into groups (male, female) followed by systematic sampling within each of these strata. For each of the strata, each incoming eligible participant will be systematically allocated to either the control or the treatment group. The starting allocation (either intervention or treatment) will be randomly selected for each of the strata (male, female) after which each 2nd participant will be allocated to the other group (either intervention or treatment). The research team note that trans and gender diverse people also take on caregiving roles. If people identify themselves as such, they are still eligible to participate; and will be allocated in the same manner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified sampling will be considered, dividing the subjects into groups (male, female) followed by systematic sampling within each of these strata. For each incoming eligible participant will be systematically allocated to either the control or the treatment group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot feasibility study, there is no planned sample size. The results from this study will inform the study design and sample size calculation for a larger scale RCT study. However, guidelines for pilot RCTs recommend an overall sample size of n=70.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2024
Date of last participant enrolment
Anticipated
Actual
6/09/2024
Date of last data collection
Anticipated
Actual
6/02/2025
Sample size
Target
70
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 322626 0
University
Name [1] 322626 0
Health Research Capacity Building Grant Scheme, Deakin University
Country [1] 322626 0
Australia
Primary sponsor type
Individual
Name
Eva Yuen - Deakin University
Address
Country
Australia
Secondary sponsor category [1] 325590 0
Individual
Name [1] 325590 0
Alison Hutchinson - Deakin University
Address [1] 325590 0
Country [1] 325590 0
Australia
Secondary sponsor category [2] 325591 0
Individual
Name [2] 325591 0
Carlene Wilson - University of Melbourne
Address [2] 325591 0
Country [2] 325591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321085 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 321085 0
Ethics committee country [1] 321085 0
Australia
Date submitted for ethics approval [1] 321085 0
22/01/2024
Approval date [1] 321085 0
18/03/2024
Ethics approval number [1] 321085 0

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

Contacts
Principal investigator
Name 152606 0
Dr Eva Yuen
Address 152606 0
Deakin University, 221 Burwood Highway, Burwood, VIC
Country 152606 0
Australia
Phone 152606 0
+61 3 9251 7074
Fax 152606 0
Email 152606 0
[email protected]
Contact person for public queries
Name 152607 0
Eva Yuen
Address 152607 0
Deakin University, 221 Burwood Highway, Burwood, VIC
Country 152607 0
Australia
Phone 152607 0
+61 3 9251 7074
Fax 152607 0
Email 152607 0
[email protected]
Contact person for scientific queries
Name 152608 0
Eva Yuen
Address 152608 0
Deakin University, 221 Burwood Highway, Burwood, VIC
Country 152608 0
Australia
Phone 152608 0
+61 3 9251 7074
Fax 152608 0
Email 152608 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.