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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
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Scientific title
Ripple: Clinical evaluation of a novel digital platform to assess the health-related quality of life of children undergoing cancer treatment
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Secondary ID [1]
309380
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
329600
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Condition category
Condition code
Cancer
326529
326529
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0
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Any cancer
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Cancer
326902
326902
0
0
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Children's - Brain
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Cancer
326903
326903
0
0
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Children's - Leukaemia & Lymphoma
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Cancer
326904
326904
0
0
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Children's - Other
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
325813
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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.
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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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.
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Primary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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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.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Data will be collected during the 12 month study period. Cumulative data will be assessed at study conclusion.
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Secondary outcome [2]
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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).
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Assessment method [2]
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Timepoint [2]
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An evaluation survey will be administered to parent study participants six months after recruitment.
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Secondary outcome [3]
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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).
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Assessment method [3]
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Timepoint [3]
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An evaluation survey will be administered to clinician study participants six months after recruitment.
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Secondary outcome [4]
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Secondary outcome 4 is the child self-reported HRQoL outcomes. This data will be analysed and reported in a de-identified cumulative manner.
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Assessment method [4]
422174
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Timepoint [4]
422174
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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.
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Secondary outcome [5]
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Secondary outcome 5 is the parent-proxy reported HRQoL outcomes. This data will be analysed and reported in a de-identified cumulative manner.
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Assessment method [5]
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Timepoint [5]
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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.
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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.
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Minimum age
5
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
14/08/2023
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Actual
26/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
46
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Accrual to date
40
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
24469
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [2]
24470
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
40051
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5006 - North Adelaide
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Recruitment postcode(s) [2]
40052
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
313575
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Charities/Societies/Foundations
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Name [1]
313575
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The Hospital Research Foundation Group
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Address [1]
313575
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Level 1, 62 Woodville Road, Woodville SA 5011
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Country [1]
313575
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Australia
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Funding source category [2]
313679
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Charities/Societies/Foundations
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Name [2]
313679
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Australian Society of Medical Imaging and Radiation Therapy
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Address [2]
313679
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Suite 1040-1044 (Level 10), 1 Queens Road Melbourne VIC 3004
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Country [2]
313679
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Australia
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Primary sponsor type
University
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Name
University of South Australia
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Address
GPO Box 2471, Adelaide SA 5001
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Country
Australia
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Secondary sponsor category [1]
315363
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None
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Name [1]
315363
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Address [1]
315363
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Country [1]
315363
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312756
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Women's and Children's Health Network (WCHN) Human Research Ethics Committee
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Ethics committee address [1]
312756
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72 King William Road, North Adelaide 5006 SA
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Ethics committee country [1]
312756
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Australia
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Date submitted for ethics approval [1]
312756
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Approval date [1]
312756
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24/03/2023
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Ethics approval number [1]
312756
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Summary
Brief summary
This study aims to assess the feasibility and acceptability of a co-designed online tool used to collect information on quality of life for children with cancer.
Who is it for?
You may be eligible for this study if you are the parent of a child aged between 5-12 years who is engaged with any stage of cancer care (e.g. diagnosis, active treatment or follow-up) at either the Women’s and Children’s Hospital (Adelaide) or the Royal Adelaide Hospital. Clinicians who are treating children who choose to participate may also be eligible for this study.
Study details
All participants who choose to enrol in this study will be given a login for the online ‘Ripple’ platform where they will answer questions about their health and quality of life. It is anticipated that the questions will take 5-10 minutes to complete. Participants and/or their parents will be asked to complete these questions 2-3 times over a 6-12 month period, depending on when they join the study. After 6 months have passed, parent and clinician participants will also be asked to complete a survey about their experience using the online platform. It is anticipated that this survey will take 10-15 minutes to complete.
It is hoped this research will determine whether an online portal for cancer patients to provide ratings of their health and quality of life is easy to use and acceptable to patients, their families and the clinicians treating them. If the portal is found to be useful and acceptable to patients, a larger rollout of the portal may occur to assist a greater number of cancer patients on their treatment journey.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Mikaela Doig
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Address
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University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
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Country
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Australia
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Phone
125794
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+61 08 8302 2292
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Fax
125794
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Email
125794
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[email protected]
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Contact person for public queries
Name
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Ms Mikaela Doig
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Address
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University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
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Country
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Australia
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Phone
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+61 08 8302 2292
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
125796
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Dr Michala Short
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Address
125796
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University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
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Country
125796
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Australia
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Phone
125796
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+61 08 8302 2089
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Fax
125796
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Email
125796
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
De-identified data aggregate will be shared.
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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.
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