Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000604505p
Ethics application status
Submitted, not yet approved
Date submitted
26/03/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
From the Ward to the Community: An Active Approach to Childhood Cancer
Scientific title
Effectiveness of an exercise oncology model in a community setting for improving physical activity levels and self-efficacy in children diagnosed with cancer: a hybrid effectiveness-implementation trial
Secondary ID [1] 311826 0
None
Universal Trial Number (UTN)
Trial acronym
MERRIER-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childhood cancer
 333357 0
Condition category
Condition code
Cancer 330038 330038 0 0
Children's - Other
Cancer 330039 330039 0 0
Children's - Leukaemia & Lymphoma
Cancer 330040 330040 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be 1:1 randomised to either an exercise intervention or control group.

The intervention group will receive five online sessions with an Accredited Exercise Physiologist (AEP) over 3 months (Sessions conducted in Weeks 1, 2, 4, 8, 12). Participants will be prescribed an exercise program individualised to their needs, physical activity levels, barriers, preferences, goals and clinical history. The program will be designed to use themselves, with their family, their community organisations and at school. Adherence will be measured based on the proportion of completed prescribed exercises using Physitrack software. Participants will be provided with basic exercise equipment (e.g. resistance bands, skipping ropes) to use at home for their program and provided with a $50 voucher to use on equipment related to their program.

Sessions with the AEP are 45-60 minutes in duration and include 20-30 minutes of interview and discussion including goal setting, going through the program, discussing barriers and enablers, providing education (short videos, infographics and resouces followed by discussion into the topic), and is followed by a 30 minute moderate-intensity (5-6/10 on Borg's RPE scale) supervised exercise session, which includes: (1) 5 minute warm-up; (2) 20 minutes of exercise training consisting of strength/resistance, balance, and aerobic activities, and (3) 5 minute cool-down consisting of full-body stretching. The AEP demonstrates each exercise, tailoring to address participants’ needs including exercise progressions or regressions. Adherence to the program will be measured using Physitrack software, where participants will mark each prescribed exercise as 'complete'.

Throughout each of the AEP sessions, participants will be provided educational resources and discussions to facilitate further learning on behaviour change techniques and key exercise principles in cancer care. Specifically, the education topics include (1) Principles of Exercise and Cancer, (2) Graded exercise: how to progress and regress, (3) Activity pacing for fatigue, (4) Digital technology and local programs, and (5) a topic chosen by participant from: managing peripheral neuropathy, social support, long-term maintenance, pain, and self-monitoring physical activity. These education topics have been built based on participant feedback, and are designed to engage participants in discussion, foster self-efficacy and equip them with the behaviour change techniques to apply in their daily life. Specific skills learnt include self-monitoring, barrier management, planning, goal setting, how to build social support, and building confidence and belief in their own ability to be physically active.

Program adaptations

The exercise intervention will be modified by using the Frequency, Intensity, Time and Type (FITT) principles. All exercises will be assessed during each AEP session, with the FITT principal for each exercise kept the same, progressed or regressed based on participant ability, exertion, compliance and symptoms. The exercise program may also be individualised for a range of different clinical reasons. Some common clinical reasons to amend exercise may include (but not limited to) the development of chemotherapy-induced peripheral neuropathy (CIPN), cardiotoxicity, osteonecrosis, acute symptoms including infections.
Intervention code [1] 328281 0
Behaviour
Comparator / control treatment
The control group will receive usual care, which will be their normal lifestyle and medical care, without additional guidance for physical activity from an accredited exercise physiologist. They will be provided consumer-friendly educational resources from the physical activity guidelines in childhood cancer (The international Pediatric Oncology Exercise Guidelines (iPOEG); https://academic.oup.com/tbm/article/11/10/1915/6284402.

The control group will be offered a delayed-start intervention after the 6-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 337797 0
Moderate-vigorous physical activity levels
Timepoint [1] 337797 0
Baseline and 3-months post-baseline (co-primary endpoint)
Primary outcome [2] 337798 0
Physical activity self-efficacy
Timepoint [2] 337798 0
Baseline, 3 months post-baseline (co-primary endpoint), 6 months post-baseline
Secondary outcome [1] 433346 0
Physical activity
Timepoint [1] 433346 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [2] 433347 0
Quality of Life
Timepoint [2] 433347 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [3] 433348 0
Perceived fitness
Timepoint [3] 433348 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [4] 433349 0
Muscle strength: Lower body
Timepoint [4] 433349 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [5] 433350 0
Muscle strength: upper body
Timepoint [5] 433350 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [6] 433351 0
Physical function
Timepoint [6] 433351 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [7] 433352 0
Balance
Timepoint [7] 433352 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [8] 433353 0
Aerobic fitness
Timepoint [8] 433353 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [9] 433354 0
Flexibility
Timepoint [9] 433354 0
Baseline, 3 months post-baseline, 6 months post-baseline
Secondary outcome [10] 433355 0
Program adherence
Timepoint [10] 433355 0
Duration of 12 week intervention
Secondary outcome [11] 433356 0
Implementation outcomes (Reach)
Timepoint [11] 433356 0
Post-completion of 12 week intervention by all participants
Secondary outcome [12] 434706 0
Implementation outcomes (Effectiveness)
Timepoint [12] 434706 0
Post-completion of 12 week intervention by all participants
Secondary outcome [13] 434707 0
Implementation outcomes (Adoption)
Timepoint [13] 434707 0
Post-completion of 12 week intervention by all participants
Secondary outcome [14] 434708 0
Implementation outcomes (Implementation)
Timepoint [14] 434708 0
Post-completion of 12 week intervention by all participants
Secondary outcome [15] 434709 0
Implementation outcomes (Maintenance)
Timepoint [15] 434709 0
Post-completion of 12 week intervention by all participants

Eligibility
Key inclusion criteria
1. Diagnosis of a malignancy at <18 years of age
2. Completed systemic treatment (maintenance chemotherapy permitted)
3. aged 5-18 at time of study enrolment
4. parent/participant willing to give informed consent.
5. Not currently participating in >60 minutes of moderate-vigorous physical activity daily
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Medical condition that would prohibit exercise participation at discretion of physician (e.g. but not limited to: Cardiomyopathy, uncontrolled cardiac arrhythmias, or other significant CVD).
2. Planned treatment during the study period that will impair participation in the study (e.g. major surgery requiring restriction from physical activity).
3. pregnant females
4. family, child, Camp Quality or treating team preference not to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following the completion of baseline assessments, participants will be assigned to either the exercise or control group in a 1:1 ratio using the online computer-generated randomisation software, Sealed Envelope.

The randomisation procedures will be overseen by an independent biostatistician who is not part of the core investigator team. This biostatistician will set a predefined randomisation schedule on the Sealed Envelope website.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed in blocks to ensure balance across important variables, including age (categorized into three groups: 5-9, 10-13, and 14-18), sex (male, female), and disease type (leukaemia, brain tumours, other solid tumours).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 52 participants are required to have a 90% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 21 min/day of moderate-vigorous physical activity in the control group to 30 min/day in the experimental group at the 3 month follow up, which was calculated using the Sealed EnvelopeTM online Power Sample Size Calculator too. Based on a drop-out rate of 15%, we will recruit 60 participants.

Descriptive statistics will be computed to describe the sample at baseline. Effectiveness of primary and secondary outcomes will be compared between groups in both intention to treat and per protocol analyses. Linear Mixed Modelling will be conducted within and between subjects to examine changes across time points (baseline [week 0], post-intervention [week 12] and 6-month follow up). The effect size of these changes across timepoints and between groups will be computed.

Exploratory analyses: Exploratory analyses will be conducted to investigate including the effect of exercise dose, cancer type (leukaemia vs brain tumours vs other solid tumours), age (ages 5-9, 10-13, 14-18), and sex (males vs females) on all outcomes.

Confounders: The study will be adjusted for relevant covariates including baseline physical activity level and self-efficacy, and by any other differences between group at baseline.

For implementation outcomes, interviews will be transcribed verbatim and uploaded into NVivo, where they will be analyzed using conventional content analysis. Transcripts will be read, with deductive coding according to the RE-AIM implementation framework, with key ideas and higher-order categories generated, which will be led by one researcher and cross-checked with a second. Selected exemplar quotes will be extracted. The penultimate coding scheme will then be sent to all authors, each of whom was involved in the study design, intervention delivery, and/or data collection, to review and approve

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
23/01/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316166 0
Charities/Societies/Foundations
Name [1] 316166 0
The Kids Cancer Project
Country [1] 316166 0
Australia
Funding source category [2] 316170 0
University
Name [2] 316170 0
University of Sydney
Country [2] 316170 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318350 0
None
Name [1] 318350 0
Address [1] 318350 0
Country [1] 318350 0
Other collaborator category [1] 282992 0
Charities/Societies/Foundations
Name [1] 282992 0
Camp Quality
Address [1] 282992 0
Country [1] 282992 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314991 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314991 0
Ethics committee country [1] 314991 0
Australia
Date submitted for ethics approval [1] 314991 0
28/03/2024
Approval date [1] 314991 0
Ethics approval number [1] 314991 0

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

Contacts
Principal investigator
Name 133346 0
Dr David Mizrahi
Address 133346 0
Daffodil Centre, Moore College Building, University of Sydney, Camperdown, 2006, Sydney, NSW
Country 133346 0
Australia
Phone 133346 0
+61 2 9351 9432
Fax 133346 0
Email 133346 0
david.mizrahi@sydney.edu.au
Contact person for public queries
Name 133347 0
David Mizrahi
Address 133347 0
Daffodil Centre, Moore College Building, University of Sydney, Camperdown, 2006, Sydney, NSW
Country 133347 0
Australia
Phone 133347 0
+61 2 9351 9432
Fax 133347 0
Email 133347 0
david.mizrahi@sydney.edu.au
Contact person for scientific queries
Name 133348 0
David Mizrahi
Address 133348 0
Daffodil Centre, Moore College Building, University of Sydney, Camperdown, 2006, Sydney, NSW
Country 133348 0
Australia
Phone 133348 0
+61 2 9351 9432
Fax 133348 0
Email 133348 0
david.mizrahi@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.