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Trial registered on ANZCTR


Registration number
ACTRN12623000573651
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
25/05/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Ripple: Clinical evaluation of a novel digital platform to assess the health-related quality of life of children undergoing cancer treatment
Scientific title
Ripple: Clinical evaluation of a novel digital platform to assess the health-related quality of life of children undergoing cancer treatment
Secondary ID [1] 309380 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 329600 0
Condition category
Condition code
Cancer 326529 326529 0 0
Any cancer
Cancer 326902 326902 0 0
Children's - Brain
Cancer 326903 326903 0 0
Children's - Leukaemia & Lymphoma
Cancer 326904 326904 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our research team have co-produced an online platform (website) with children, families and clinicians to streamline how quality of life is assessed to in paediatric oncology clinical practice. An existing data capture platform ‘Ripple’, has been adapted to include quality of life assessment for children with cancer.

The study intervention is self-reported and parent-proxy reported health-related quality of life (HRQoL) assessment using a Ripple. Children and parents can choose to login to Ripple using an email link or a QR code. The parent will be required to supply an email to create the account. Upon completion of the first parent-proxy reported HRQoL entry, parents will be prompted to select a password for their account.

The primary managing clinician of the child participant and research team will coordinate the ongoing HRQoL assessment schedule for children to align with the child’s treatment and/or follow-up milestones. Participating clinicians will be given access to the HRQoL assessment results of children under their care in the Ripple platform.

For children undergoing treatment, the child and parent can expect to complete approximately three to five HRQoL assessments each over the 12 month study period. For children receiving follow up care, the child and parent can expect to complete approximately two quality of life assessments over the 12 month study period. Each HRQoL assessment will take approximately 5-10 minutes to complete at each time point.

At recruitment, children and parents will be provided with infographic and text instructions on how to use the Ripple platform. In person assistance to help the child and parent complete the first assessment will be offered by the recruiting healthcare professional or study coordinators. Additional ad hoc support from the clinic champion, study coordinators or healthcare professionals engaged in this study will be available to assist children and parents complete future assessments.

Study coordinators and the nominated clinic champion will provide 1hr of formal training for clinicians (either in a single 1hr session or two 30min sessions) prior to using the Ripple platform. After formal training, healthcare professionals will receive physical and online training materials, including orientation for using the Ripple platform and guidance based on available literature regarding interpretation of patient reported outcome results. Additional ad-hoc support for healthcare professionals will be provided by the clinic champion and study coordinators as requested.

This study will test the feasibility of using the platform as an additional clinical assessment, to help children convey their HRQoL and to allow the child’s clinicians to use this information as a part of their patient-centred care. In addition to collecting HRQoL assessments, we will use platform analytics and a survey to evaluate how children, parents and healthcare professionals use the platform.

No changes to usual treatment or procedures within the existing standards of care will occur for participants. HRQoL assessment using this platform will be an additional supportive care method to accompany existing clinical processes and will not replace any existing clinical care measures. The platform will be used for data capture. It will not provide any educational or support resources.
Intervention code [1] 325813 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334369 0
Primary outcome 1 is the compliance of child users completing HRQoL assessments using the Ripple platform. This will be assessed using appropriate analytics within the platform.
Timepoint [1] 334369 0
Data will be collected during the 12 month study period to correspond with the child's existing clinical milestones, as determined by their primary clinician. Analysis will be performed three monthly over the study period. Cumulative data will be assessed at study conclusion.
Primary outcome [2] 334816 0
Primary outcome 2 is the compliance of parent users completing HRQoL assessments using the Ripple platform. This will be assessed using appropriate analytics within the platform.
Timepoint [2] 334816 0
Parent-proxy reported data will be collected during the 12 month study period to correspond with the child's existing clinical milestones, as determined by their primary clinician. Analysis will be performed three monthly over the study period. Cumulative data will be assessed at study conclusion.
Primary outcome [3] 334817 0
Primary outcome 3 is the compliance of clinician users viewing assessment results within the Ripple platform. This will be assessed using appropriate analytics within the platform.
Timepoint [3] 334817 0
Clinicians will review HRQoL assessment data in the Ripple platform during the 12 month study period. Clinicians will only have access to the results of the patients directly under their care. Children and parents will complete HRQoL assessments according to existing clinical milestones. This clinical milestone will align with an existing clinical task for the healthcare professional participant (e.g. treatment review consult).
Analysis will be performed three monthly over the study period. Cumulative data will be assessed at study conclusion.
Secondary outcome [1] 420419 0
Secondary outcome 1 is changes in clinical management due to the patient reported outcome responses. Any action or changes to clinical management prompted as a result of HRQoL assessment results will be documented in the patient’s medical record by the clinicians.
Timepoint [1] 420419 0
Data will be collected during the 12 month study period. Cumulative data will be assessed at study conclusion.
Secondary outcome [2] 420421 0
Secondary outcome 2 is the perspectives of the Ripple platform from parent users. This data will be collected using an anonymous online study-specific questionnaire, with questions addressing established domains for evaluating healthcare technology and implementation research (e.g. usability and feasibility).
Timepoint [2] 420421 0
An evaluation survey will be administered to parent study participants six months after recruitment.
Secondary outcome [3] 422173 0
Secondary outcome 3 is the perspectives of the Ripple platform from clinician users. This data will be collected using an anonymous online study-specific questionnaire, with questions addressing established domains for evaluating healthcare technology and implementation research (e.g. usability and feasibility).
Timepoint [3] 422173 0
An evaluation survey will be administered to clinician study participants six months after recruitment.
Secondary outcome [4] 422174 0
Secondary outcome 4 is the child self-reported HRQoL outcomes. This data will be analysed and reported in a de-identified cumulative manner.
Timepoint [4] 422174 0
Data will be collected during the 12 month study period. For each child participant, the first HRQoL assessment will be completed upon recruitment. Additional assessments will be mapped to clinical milestones, as described previously. Cumulative data will be assessed at study conclusion.
Secondary outcome [5] 422175 0
Secondary outcome 5 is the parent-proxy reported HRQoL outcomes. This data will be analysed and reported in a de-identified cumulative manner.
Timepoint [5] 422175 0
Data will be collected during the 12 month study period. For each participant, the first HRQoL assessment will be completed upon recruitment. Additional assessments will be mapped to the child's clinical milestones, as described previously. Cumulative data will be assessed at study conclusion.

Eligibility
Key inclusion criteria
Children aged 5-12 years who are engaged with any stage of cancer care (e.g. diagnosis, active treatment or follow-up) at the participating study sites will be eligible for participation.

Parents of eligible children will be eligible to participate in parent-proxy reporting of their child's health-related quality of life.

Healthcare professionals involved in the care of eligible children will be invited as study participants.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children receiving palliative care or end of life care are ineligible.
If a child is unable to self-report due to their literacy level, unwillingness or decline in health status, parent-proxy only reporting will be permitted.

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Due to the small sample of children with cancer in South Australia, all children meeting the
inclusion criteria will be invited to participate. Our target sample is 20 children, 20 parents and 6 healthcare professionals. The estimated minimum number of HRQoL assessments per patient is two assessments whilst on follow-up and three to five assessments for patients undergoing active treatment.

The feasibility of HRQoL assessment in clinical practice will be measured by the participant compliance, changes to clinical management and survey results. This will include quantitative and qualitative methods of analyses. Self-reported and parent-proxy reported HRQoL data will be analysed using descriptive statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2023
Actual
26/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24469 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 24470 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 40051 0
5006 - North Adelaide
Recruitment postcode(s) [2] 40052 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313575 0
Charities/Societies/Foundations
Name [1] 313575 0
The Hospital Research Foundation Group
Country [1] 313575 0
Australia
Funding source category [2] 313679 0
Charities/Societies/Foundations
Name [2] 313679 0
Australian Society of Medical Imaging and Radiation Therapy
Country [2] 313679 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 315363 0
None
Name [1] 315363 0
Address [1] 315363 0
Country [1] 315363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312756 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee
Ethics committee address [1] 312756 0
Ethics committee country [1] 312756 0
Australia
Date submitted for ethics approval [1] 312756 0
Approval date [1] 312756 0
24/03/2023
Ethics approval number [1] 312756 0

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

Contacts
Principal investigator
Name 125794 0
Ms Mikaela Doig
Address 125794 0
University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
Country 125794 0
Australia
Phone 125794 0
+61 08 8302 2292
Fax 125794 0
Email 125794 0
[email protected]
Contact person for public queries
Name 125795 0
Mikaela Doig
Address 125795 0
University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
Country 125795 0
Australia
Phone 125795 0
+61 08 8302 2292
Fax 125795 0
Email 125795 0
[email protected]
Contact person for scientific queries
Name 125796 0
Michala Short
Address 125796 0
University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
Country 125796 0
Australia
Phone 125796 0
+61 08 8302 2089
Fax 125796 0
Email 125796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data aggregate will be shared.


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.