Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000259842
Ethics application status
Approved
Date submitted
13/01/2021
Date registered
10/03/2021
Date last updated
10/03/2021
Date data sharing statement initially provided
10/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a digital educational physical activity program for childhood cancer survivors
Scientific title
Feasibility and acceptability of a digital educational physical activity program for management of cardiometabolic complications in children who have survived cancer.
Secondary ID [1] 303155 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childhood cancer 320276 0
Condition category
Condition code
Cancer 318203 318203 0 0
Children's - Leukaemia & Lymphoma
Cancer 318204 318204 0 0
Children's - Brain
Cancer 318205 318205 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will assess the feasibility and acceptability of a digital educational program for childhood cancer survivors (CCS). It is a 12-week intervention with a 3-month follow-up assessed remotely using our program. The project is looking to recruit 40 children who are 8-13 years old. Participants are survivors of cancer, each of whom have finished their
cancer treatment for at least 12 months or are in the maintenance phase of leukemia chemotherapy.

This project will offer young survivors access to an online distance-delivered intervention that focuses on healthy behaviours such as physical activity and unhealthy behaviours such as sugar-sweetened beverage consumption and sedentary behaviours. The intervention will involve:
i. Two face-to-face consults to collect baseline and post-intervention assessments including assessment of cardiovascular fitness, body composition, physical activity levels, quality of life, health literacy and sugar-sweetened beverage intake.
ii. Online educational modules that focus on healthy behaviours, unhealthy behaviours and physical activity goal setting. Mode of training include physical activities designed to include family and friends, short videos, quizzes, and interactive activities. Educational material was adapted from a previous study testing the educational program in 12-13 year old children. Participants are asked to complete one module per week for the 12 week intervention period (including baseline and follow-up), with each educational module taking approximately 45-60 minutes to complete. Any exercise undertaken by participants were at their own discretion.
iii. A tablet with the online educational modules and corresponding activity tracker application.
iv. Activity tracker to allow real-time feedback and motivation for step count goals. A corresponding app will be linked onto the tablet that provides daily, weekly and monthly step counts in conjunction with physical activity intensity (e.g. light, moderate or vigorous physical activity). This allows the user to assess their own physical activity levels over
time and make goals to increase physical activity.

Strategies used to monitor adherence to the intervention include accessing back office app analytics provided by our industry partner, BePatient.
Intervention code [1] 319464 0
Lifestyle
Intervention code [2] 319691 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326187 0
Feasibility assessed by:
- Usage of the program (completion of activities and challenges on program)
- Activity tracker compliance (number of hours or days worn by participant)
- Participant retention (completion of intervention and follow-up visits/questionnaires)
- Recruitment rate determined by audit of the study database
- Adverse events (patient-reported)
Timepoint [1] 326187 0
Baseline, post-intervention time point (12 weeks)
Primary outcome [2] 326188 0
Acceptability will be measured using a questionnaire specifically developed for this study (collecting both qualitative and quantitative data). Questions relate to the acceptability of the program and services received using the Youth Satisfaction Questionnaire (YSQ). The YSQ includes 5 items assessing satisfaction with care and overall experience.
Timepoint [2] 326188 0
12 weeks (post intervention)
Secondary outcome [1] 390431 0
Physical activity levels will be assessed using time spent in moderate to vigorous physical activity according to the GeneActiv activity tracker,
Timepoint [1] 390431 0
Baseline and post-intervention (12-weeks) for 7 consecutive days.
Secondary outcome [2] 390432 0
Cardiovascular fitness assessed using the 6-minute walk test.
Timepoint [2] 390432 0
Baseline, 12-weeks post-intervention commencement and 3-months post-intervention completion.
Secondary outcome [3] 390435 0
Sugar sweetened beverage intake assessed using a validated questionnaire (Child Nutrition Questionnaire).
Timepoint [3] 390435 0
Baseline, 12-weeks post intervention commencement.

Eligibility
Key inclusion criteria
Aged 8-13 years, completed cancer treatment for at
least 12 months or in maintenance phase of leukemia chemotherapy,
consenting parent/participant able to communicate and read in English,
parent/participant willing to give informed consent, internet access at
home.
Minimum age
8 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently undergoing treatment, cancer relapse after recruitment, current medical condition that would prohibit exercise, no internet access at home, survivors currently already participating in another research study that will affect study primary and secondary
outcomes, previously completed research study less than or equal to 4-6 weeks.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size for this project is 40 survivors over 3 years. We aim to enrol 40 participants including drop outs. This is a pilot study with the goal of testing feasibility and acceptability, therefore there is no initial power analysis to calculate a required sample size. A sample size of approximately 40 participants is considered sufficient for the purpose of: providing initial feedback data to improve the intervention; testing the planned recruitment method; and assessing the acceptability of the intervention from the perspective of participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/05/2019
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
40
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18411 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 32506 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307561 0
University
Name [1] 307561 0
University of New South Wales, Sydney
Country [1] 307561 0
Australia
Primary sponsor type
Individual
Name
A/Prof David Simar
Address
School of Medical Sciences, Faculty of Medicine, UNSW Sydney, Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 308519 0
None
Name [1] 308519 0
Address [1] 308519 0
Country [1] 308519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307623 0
Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 307623 0
Ethics committee country [1] 307623 0
Australia
Date submitted for ethics approval [1] 307623 0
16/11/2018
Approval date [1] 307623 0
04/12/2018
Ethics approval number [1] 307623 0
HREC/18/SCHN/471

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

Contacts
Principal investigator
Name 107898 0
Prof Claire Wakefield
Address 107898 0
Behavioural Sciences Unit, Kids Cancer, Centre, Sydney Children’s Hospital, High St, Randwick NSW 2031
Country 107898 0
Australia
Phone 107898 0
+61 425 336 571
Fax 107898 0
Email 107898 0
[email protected]
Contact person for public queries
Name 107899 0
Lauren Ha
Address 107899 0
School of Health Sciences, Faculty of Medicine, UNSW Sydney, Kensington NSW 2052
Country 107899 0
Australia
Phone 107899 0
+61 433788662
Fax 107899 0
Email 107899 0
[email protected]
Contact person for scientific queries
Name 107900 0
Lauren Ha
Address 107900 0
School of Health Sciences, Faculty of Medicine, UNSW Sydney, Kensington NSW 2052
Country 107900 0
Australia
Phone 107900 0
+61 433788662
Fax 107900 0
Email 107900 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results only (after request).
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal and at the discretion of the primary sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof Claire Wakefield [email protected]) or study coordinator (Ms Lauren Ha [email protected])


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
SourceTitleYear of PublicationDOI
EmbaseA Digital Educational Intervention With Wearable Activity Trackers to Support Health Behaviors Among Childhood Cancer Survivors: Pilot Feasibility and Acceptability Study.2022https://dx.doi.org/10.2196/38367
N.B. These documents automatically identified may not have been verified by the study sponsor.