Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000454572
Ethics application status
Approved
Date submitted
6/03/2024
Date registered
12/04/2024
Date last updated
2/10/2024
Date data sharing statement initially provided
12/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Development, feasibility, and efficacy of a co-designed exercise program for survivors of paediatric sarcoma
Scientific title
Development, feasibility, and efficacy of a co-designed exercise program for survivors of paediatric sarcoma
Secondary ID [1] 311627 0
PFG_FULL_2023_004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood sarcoma 333065 0
Condition category
Condition code
Cancer 329750 329750 0 0
Sarcoma (also see 'Bone') - soft tissue
Physical Medicine / Rehabilitation 329784 329784 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Goal-directed therapeutic exercise program.

Participants will receive one weekly 30-60 minute individualised, goal-directed therapeutic exercise therapy program for 12 weeks, delivered face-to-face by a trained physiotherapist or exercise physiologist, with an accompanying home-based program to be completed three times per week.
Exercise intensity will be monitored using wearable sensors (ActiGraph GT3x+ and heart rate monitors) and/or perceived effort using the OMNI scale.
Participants will be assessed (via questionnaire and physical assessments) at the beginning, end-intervention (~12 weeks), and at a 6-month follow-up by a trained physiotherapist or exercise physiologist.
The exercise intervention will be tailored according to participant age, e.g., game-based activities for younger children, and may informally include peers or siblings to promote adherence to the home-based component. Peers or siblings will not be trained to assist with the exercise program.
The exercise intervention prescribed via goal-directed therapy, aligns with the principles of the International Classification and Functioning, Disability and Health framework (ICF), and will predominately be guided by the goals set by the participant. The program will adhere to established exercise prescription guidelines, comprising of physical activity and goal-directed task specific practice. At least half of the session will be dedicated to cardiorespiratory-focused and functional strength promoting activities i.e., running, ball games and locomotion play games, body weight exercises, bear crawls, and frog jumps. The remaining half is dedicated to goal-directed activities. Goals selected will be physical activity related and may include community recreation, occupational, sport or leisure goals. Specific examples of goal-directed activities will, therefore, vary and be individualised according to each participant’s age, goals, interests and functional capacity, presence of treatment-related side effects, and co-morbidities. The home-based program will replicate the essential elements of the supervised sessions in relation to activity type and will also reflect the resources at home.
Adherence to the intervention will be assessed by the physiotherapist or exercise physiologist who will complete a study logbook to record details about the exercises prescribed and the exercises completed.
The CI's will evaluate adherence to the program using attendance records and data from wearable sensors. Acceptability will be measured by questionnaire and structured interviews.
Intervention code [1] 328090 0
Rehabilitation
Intervention code [2] 328105 0
Lifestyle
Intervention code [3] 328106 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337547 0
Program Feasibility
Timepoint [1] 337547 0
Baseline (T1) and , 12 weeks post-intervention commencement
Primary outcome [2] 337562 0
Program Feasibility
Timepoint [2] 337562 0
12 weeks (T2) post-intervention commencement
Primary outcome [3] 337883 0
Program Feasibility
Timepoint [3] 337883 0
Baseline (T1) and, 12 weeks (T2) post intervention commencement
Secondary outcome [1] 432331 0
Program Feasibility (Primary outcome measure).
Timepoint [1] 432331 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.
Secondary outcome [2] 432334 0
Program acceptability (Primary outcome measure).
Timepoint [2] 432334 0
12 weeks (T2) post-intervention commencement
Secondary outcome [3] 432335 0
Program acceptability (Primary outcome measure).
Timepoint [3] 432335 0
12 weeks (T2) post-intervention commencement
Secondary outcome [4] 433585 0
Cardiorespiratory Fitness
Timepoint [4] 433585 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.
Secondary outcome [5] 433586 0
Functional ability
Timepoint [5] 433586 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.
Secondary outcome [6] 433587 0
Functional ability
Timepoint [6] 433587 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.
Secondary outcome [7] 433588 0
Functional ability
Timepoint [7] 433588 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.
Secondary outcome [8] 433596 0
Functional ability
Timepoint [8] 433596 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.
Secondary outcome [9] 433597 0
Habitual physical activity
Timepoint [9] 433597 0
Baseline (T1), 12 weeks (T2) and 6 months (T3) post intervention commencement.

Eligibility
Key inclusion criteria
Eligibility criteria: (1) Children (8 to 18 years); (2) diagnosis of sarcoma that required surgical resection at least 12 months earlier, but no more than 5 years (60 months) prior to enrolment; (3) no chemotherapy or radiation therapy received in the last 6 months; (4) no evidence of progressive disease; and (5) medically able to complete an exercise program.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
(1) they have insufficient English to complete study assessments or participate in the exercise intervention;
(2) the study is not suitable as assessed by the clinical lead investigator;
(3) concurrent medical condition that would prohibit exercise testing or may jeopardise the ability of the patient to undergo the exercise intervention with reasonable safety. This includes but is not limited to unstable angina or arrhythmia, acute myocarditis, uncontrolled heart failure, lower extremity thrombus, uncontrolled asthma, severe mental impairment, or other inability to consent. These will be assessed on a case-by-case basis by the clinical lead investigator;
(4) the participant is unable to travel to the research facility to complete study assessments.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Following established procedures for estimating the sample size requirements for pilot studies, the minimum sample size requirement was set to 15 participants. This calculation was based on detecting a hypothesised pre to post-change of at least 0.5 standard deviations (moderate effect size) in aerobic fitness, functional ability, and device measured physical activity, a power level of 0.80, and 2-tailed alpha level of 0.05. To offset a projected attrition rate of 25%, our sample size of 15 will be increased to 20 participants.

Change in the primary outcomes will be tested for statistical significance immediately post-intervention and 6-month follow-up using general linear models (e.g., one-way repeated measures ANOVA) or generalised linear models, depending on the observed underlying distributions of the outcomes. Differences from baseline will be tested using a priori single degree of freedom contrasts.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26237 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 42205 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 315951 0
Charities/Societies/Foundations
Name [1] 315951 0
Wereld Kanker Onderzoek Fonds (WKOF)
Country [1] 315951 0
Netherlands
Funding source category [2] 316012 0
Charities/Societies/Foundations
Name [2] 316012 0
World Cancer Research Fund International
Country [2] 316012 0
United Kingdom
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318163 0
None
Name [1] 318163 0
Address [1] 318163 0
Country [1] 318163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314779 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314779 0
Ethics committee country [1] 314779 0
Australia
Date submitted for ethics approval [1] 314779 0
20/11/2023
Approval date [1] 314779 0
06/02/2024
Ethics approval number [1] 314779 0
HREC/23/QCHQ/103918

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

Contacts
Principal investigator
Name 132698 0
Prof Stewart Trost
Address 132698 0
The University of Queensland, School of Human Movement and Nutrition Sciences, Faculty of Health and Behavioural Sciences, at QLD Centre for Children’s Health Research (CCHR), Level 7. 62 Graham Street, South Brisbane, QLD 4101
Country 132698 0
Australia
Phone 132698 0
+61 0401368975
Fax 132698 0
Email 132698 0
[email protected]
Contact person for public queries
Name 132699 0
Stewart Trost
Address 132699 0
The University of Queensland, School of Human Movement and Nutrition Sciences, Faculty of Health and Behavioural Sciences, at QLD Centre for Children’s Health Research (CCHR), Level 7. 62 Graham Street, South Brisbane, QLD 4101
Country 132699 0
Australia
Phone 132699 0
+61 0401368975
Fax 132699 0
Email 132699 0
[email protected]
Contact person for scientific queries
Name 132700 0
Stewart Trost
Address 132700 0
The University of Queensland, School of Human Movement and Nutrition Sciences, Faculty of Health and Behavioural Sciences, at QLD Centre for Children’s Health Research (CCHR), Level 7. 62 Graham Street, South Brisbane, QLD 4101
Country 132700 0
Australia
Phone 132700 0
+61 0401368975
Fax 132700 0
Email 132700 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?
Researchers will be able to contact the PI for access to data. De-identifiable individual participant data of primary and secondary outcomes will be shared. Data will be maintained in a csv.
When will data be available (start and end dates)?
Immediately following the publication of the primary outcomes paper. There is no end date for the data to be available.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Data will be made available by emailing the Principal Investigator at [email protected]. Access will be subject to approvals by the Principal Investigator.


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.