Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001084875
Ethics application status
Approved
Date submitted
16/06/2021
Date registered
16/08/2021
Date last updated
20/07/2022
Date data sharing statement initially provided
16/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising symptom management in children with cancer using a novel mobile phone application
Scientific title
Optimising symptom management in children with cancer using a novel mobile phone application: a hybrid effectiveness implementation study
Secondary ID [1] 304363 0
none
Universal Trial Number (UTN)
Trial acronym
RESPONSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 322350 0
Psychological symptoms related to cancer treatment including: worry, sadness, anger and anxiety 322351 0
Chemotherapy related problems with thinking, remembering or concentration 322689 0
Body image concerns related to cancer treatment (e.g. hair loss, scars, amputation) 322690 0
Fatigue 322691 0
Chemotherapy induced mucositis 322692 0
Headache related to cancer or cancer treatment 322693 0
Pain related cancer or cancer treatment 322694 0
Chemotherapy induce peripheral neuropathy 322695 0
Chemotherapy induced nausea or vomiting 322696 0
Changes in appetite related to cancer or cancer treatment 322697 0
Changes in taste related to chemotherapy 322698 0
Constipation related to cancer or cancer treatment 322699 0
Diarrhea related to cancer or cancer treatment 322700 0
Changes in how you body moves related to cancer or cancer treatment 322701 0
Sleeping more than usual 322702 0
Sleeping less than usual 322703 0
Condition category
Condition code
Cancer 320027 320027 0 0
Children's - Leukaemia & Lymphoma
Cancer 320028 320028 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Symptom monitoring through completion of the SSPedi Patient Reported Outcome Measure using a mobile phone application weekly for eight weeks. The intervention is delivered and managed by clinical nursing teams using a patient dashboard. Notifications are sent weekly via the clinical dashboard to enrolled participants, requesting them to complete the SSPedi measure. Up to two reminder notifications are sent after 24 and 48 hours if SSPedi is not completed. Each completion of SSPedi take approximately 10 minutes to complete and review the recommendations. The intervention therefore is anticipated to take 1 x 10 minutes of app use each weeks for 8 weeks.

Upon completion of SSPedi, stratified alerts based upon pre-defined algorithms, are presented to participants through the mobile app. There are three possible alerts based upon a traffic light system: green= no symptoms of concern; amber= symptoms of concern to be discussed at next clinic visits or when convenient; red= concerning symptoms that require urgent discussion with clinical team, click to call function to phone hospital is presented in app.

Participants can access to symptom management recommendations and view graphical displays of symptom trends over time through the app (the RESPONSE system). Participants interact with the RESPONSE system as part of their enrollment in the study.

The app is patient facing. Participants are encouraged to share the SSPedi graphs during clinical visits with their healthcare team, but this is not a requirement of participation in the study and there is no formal mechanism for clinicians to view the graphs.
Intervention code [1] 320861 0
Treatment: Devices
Intervention code [2] 321077 0
Early detection / Screening
Intervention code [3] 321078 0
Behaviour
Comparator / control treatment
The comparator group receive usual care. Participants in the control group are recruited from the children's oncology outpatient clinic and commenced recruitment in January 2020 and recruitment will continue during development and testing of the RESPONSE system. (anticipated recruitment will continue for the control group until March 2022)
Control group
Historical

Outcomes
Primary outcome [1] 327889 0
The primary outcome is total symptom burden measured weekly by the SSPedi.
Timepoint [1] 327889 0
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Secondary outcome [1] 396895 0
Health-related quality-of-life (PedsQL Cancer Module)
Timepoint [1] 396895 0
Baseline, Week 1, Week 4, Week 8
Secondary outcome [2] 397856 0
Pain (FACES pain scale)
Timepoint [2] 397856 0
Week 1, Week 4, Week 8
Secondary outcome [3] 397857 0
Complications during study period will be collected from medical records
Timepoint [3] 397857 0
Follow up at end of study
Secondary outcome [4] 397858 0
Distress (Paediatric Distress thermometer)
Timepoint [4] 397858 0
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Secondary outcome [5] 412062 0
Self-efficacy (Brief Resilient Coping Scale) The tool will be used in the intervention group only.
Timepoint [5] 412062 0
Baseline, Week 4, week 8

Eligibility
Key inclusion criteria
Children aged 2-18 years, receiving active treatment for blood cancer or solid tumors and their caregiver/s aged 18 years and over are included. Active treatment for cancer is defined as receiving either planned cycles of chemotherapy or radiotherapy. Participants will be recruited within two weeks of a planned treatment cycle. Prior to recruitment, their clinical status and the appropriateness to approach potential participants will be confirmed with the treating clinicians. Participants are required to be able to read and understand English, and to have access to a smartphone, iPad or computer and Internet
Minimum age
2 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with brain cancer are excluded from this study due to multiple competing studies currently being undertaken in children’s brain cancer at the cancer centre and the concern of overburdening participants. Furthermore, participants will be excluded if there is difficulty with obtaining consent (e.g. the child is under child protection orders), or if there are difficulties understanding English

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Historical control group matched 1:1
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes in total symptom burden as measured by the SSPedi between the intervention and control group will be descriptively reported and examined using mixed linear mixed-effects models accounting for repeated observations from the same child. This will also allow for exploration of effects both within and between individuals, as well as the intervention and control groups. Potentially confounding co-variables will be included, particularly if any demographic or clinical differences are identified between groups at baseline. Outcomes will be stratified by the person completing the measures (caregiver, child participant or co-completion) and gender to determine whether effects differ based upon these factors. A sensitivity analysis will also be conducted, where possible, to compare results between caregiver versus child participant report. The amount and types of missing data will be descriptively reported. Missing data at random will be imputed, and sensitivity analysis will be completed to investigate possible sources of bias due to missing data. The characteristics of symptom burden over the eight-week study duration, as well as any pharmacological or non-pharmacological interventions or referrals provided to address symptoms will be described. Quantitative data analysis will be undertaken with SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/01/2020
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
192
Accrual to date
69
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19745 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 34386 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 308735 0
Government body
Name [1] 308735 0
National Health and Medical Research Council
Country [1] 308735 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
GPO Box 2434
Brisbane, QLD 4001
Australia
Country
Australia
Secondary sponsor category [1] 309631 0
Hospital
Name [1] 309631 0
Queensland Children's Hospital
Address [1] 309631 0
501 Stanley St South Brisbane 4101 QLD, Australia
Country [1] 309631 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308655 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 308655 0
Ethics committee country [1] 308655 0
Australia
Date submitted for ethics approval [1] 308655 0
19/01/2018
Approval date [1] 308655 0
14/02/2018
Ethics approval number [1] 308655 0
HREC/18/QRCH/18

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

Contacts
Principal investigator
Name 111442 0
A/Prof Natalie Bradford
Address 111442 0
Queensland University of technology at Centre for Children's Health Research 62 Graham St South Brisbane QLD, 4101
Country 111442 0
Australia
Phone 111442 0
+61 7 32677849
Fax 111442 0
Email 111442 0
[email protected]
Contact person for public queries
Name 111443 0
Natalie Bradford
Address 111443 0
Queensland University of Technology at Centre for Children's Health Queensland 62 Graham St South Brisbane QLD, 4101
Country 111443 0
Australia
Phone 111443 0
+61732677849
Fax 111443 0
Email 111443 0
[email protected]
Contact person for scientific queries
Name 111444 0
Natalie Bradford
Address 111444 0
Queensland University of Technology at Centre for Children's Health Queensland 62 Graham St South Brisbane 4101
Country 111444 0
Australia
Phone 111444 0
+61732677849
Fax 111444 0
Email 111444 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 who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data collected during the trial, after de-identification will be available

What types of analyses could be done with individual participant data?
• To achieve the aims in the approved proposal,

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator. Contact [email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12100Study protocolhttps://link.springer.com/article/10.1186/s12913-021-06943-x   Now published Study-related document.pdf
12101Informed consent form  [email protected]
12102Ethical approval  [email protected]



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.