ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

childhood cancer

Condition category

Condition code

Cancer

Children's - Leukaemia & Lymphoma

Cancer

Children's - Brain

Cancer

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]

Lifestyle

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline, post-intervention time point (12 weeks)

Primary outcome [2]

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]

12 weeks (post intervention)

Secondary outcome [1]

Physical activity levels will be assessed using time spent in moderate to vigorous physical activity according to the GeneActiv activity tracker,

Timepoint [1]

Baseline and post-intervention (12-weeks) for 7 consecutive days.

Secondary outcome [2]

Cardiovascular fitness assessed using the 6-minute walk test.

Timepoint [2]

Baseline, 12-weeks post-intervention commencement and 3-months post-intervention completion.

Secondary outcome [3]

Sugar sweetened beverage intake assessed using a validated questionnaire (Child Nutrition Questionnaire).

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Sydney Children's Hospital - Randwick

Recruitment postcode(s) [1]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales, Sydney

Address [1]

UNSW Sydney, Kensington, NSW 2052

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Children's Hospital Network Human Research Ethics Committee

Ethics committee address [1]

Corner Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Sydney Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2018

Approval date [1]

04/12/2018

Ethics approval number [1]

HREC/18/SCHN/471

Summary

Brief summary

This trial aims to determine the feasibility and acceptability of a digital educational physical activity program in children who have survived cancer, and to evaluate its impact on physical activity levels, cardiovascular fitness, quality of life, and sugar-sweetened beverage intake in these children.

Who is it for?
You may be eligible for this study if you are aged 8-13 years, and have completed cancer treatment at least 12 months ago or are in the maintenance phase of leukaemia chemotherapy.

Study details
Participants will be given a tablet with an installed app that delivers a physical activity education program over 12 weeks through ten 60-minute interactive modules. Participants will also be provided with an activity tracker to wear for the duration of the study. A number of questionnaires will be given before and after the study to assess feasibility and acceptability of the program, and the level of fitness will be assessed at baseline, after the 12 weeks and at 3-month follow-up using the 6-minute walk test, where the participant walks as fast as they can in a 6-minute period.

It is hoped that this study may help to foster healthy behaviours and improve physical fitness in childhood cancer survivors.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Claire Wakefield

Address

Behavioural Sciences Unit, Kids Cancer, Centre, Sydney Children’s Hospital, High St, Randwick NSW 2031

Country

Australia

Phone

+61 425 336 571

Fax

C.Wakefield@unsw.edu.au

Contact person for public queries

Name

Lauren Ha

Address

School of Health Sciences, Faculty of Medicine, UNSW Sydney, Kensington NSW 2052

Country

Australia

Phone

+61 433788662

Fax

lauren.ha@unsw.edu.au

Contact person for scientific queries

Name

Lauren Ha

Address

School of Health Sciences, Faculty of Medicine, UNSW Sydney, Kensington NSW 2052

Country

Australia

Phone

+61 433788662

Fax

lauren.ha@unsw.edu.au

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 c.wakefield@unsw.edu.au) or study coordinator (Ms Lauren Ha lauren.ha@unsw.edu.au)

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

Source	Title	Year of Publication	DOI
Embase	A Digital Educational Intervention With Wearable Activity Trackers to Support Health Behaviors Among Childhood Cancer Survivors: Pilot Feasibility and Acceptability Study.	2022	https://dx.doi.org/10.2196/38367

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically