An interventional study of Complex physical activity intervention in Pediatric Cancer, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Australia. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Supportive care
This study will evaluate a physical activity intervention for children during acute cancer treatment. The intervention aims to encourage children to participate in increased levels of physical activity and reduce the amount of time they spend engaged in sedentary activities. This study also aims to evaluate different ways of assessing physical function in order to determine the best outcome measure to use for children during acute cancer treatment.
All participants will receive the intervention which involves weekly sessions with a physiotherapist and the provision of an activity tracker. The sessions will aim to help motivate participants to be more physically active and identify barriers to physical activity in their environment. The activity tracker will be used to set a steps per day goal for the participant to achieve.
The intervention will be assessed for feasibility using aspects of the Bowen Framework. Under this framework the intervention will be evaluated according to different domains:
In order to find out the best way to assess physical function, participants will complete 5 different assessments. The results from these assessments will help to determine the best measure to use in this population.
Murdoch Childrens Research Institute is the lead sponsor of 96 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioural change techniques to promote physical activity
Behavioral: Complex physical activity intervention
Structured weekly sessions with a Physiotherapist over an 8 week period, including: * Evaluation of current levels of physical activity and physical function - including discussion of results * Education regarding the importance of physical activity * Supervised physical activity session with a physiotherapist * Structured weekly sessions applying behavioural change techniques which aim to increase participation in physical activity. Sessions include: provision of activity monitor (Fitbit Inspire), goal setting, monitoring, collaborative problem solving and action plan implementation. Intervention includes additional time allowance of 1 hour per week to assist in implementing action plan items
Demand for the intervention
Recruitment rate (comparing the number of people recruited to the number of potentially eligible participants), and documenting the reasons for non-participation.
Time frame: Through completion of recruitment, estimated as 9 months
Acceptability of the intervention according to participants
Participant and participant guardian perspective on intervention satisfaction and potential areas of improvement via semi-structured interviews
Time frame: After completion of the intervention (on average 8 weeks)
Acceptability of the intervention according to staff
Staff perspective on intervention satisfaction and potential areas of improvement via focus groups with staff members
Time frame: Through study completion, estimated as 1 year
Implementation of the intervention: adherence to wearing Fitbit
Adherence to wearing the Fitbit for monitoring, percentage of complete Fitbit data days out of total intervention days
Time frame: Post intervention (on average 8 weeks)
Implementation of the intervention: attendance to intervention sessions
Adherence to attending intervention sessions, percentage of intervention sessions that were attended
Time frame: Post intervention (on average 8 weeks)
Implementation of the intervention: ability for participants to attain their steps per day goal
Goal attainment, percentage of days out of total intervention days that participant was able to achieve their steps per day target
Time frame: Post intervention (on average 8 weeks)
Practicality of the intervention: adverse events
Measured by number of adverse events reported related to trial procedures. At each trial visit, participants will be asked "How have you felt since your last visit?" in order to elicit any changes in their well-being. They will also be asked if they have had any falls, new injuries, felt distress as a result of the intervention or experienced a change in medical or mobility status. Adverse events relevant to participant safety will also be documented from correspondence from their primary care physician or from the medical record. Adverse events recorded as serious or non-serious, related or not related to the intervention.
Time frame: Post the participant's final trial visit (on average 12 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph steps per day
Mean change from pre to post intervention in average steps taken per day measured via the Actigraph
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit steps per day
Mean change from pre to post intervention in average steps taken per day measured via the Fitbit
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph distance travelled per day
Mean change from pre to post intervention in average distance travelled per day measured via the Actigraph
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit distance travelled per day
Mean change from pre to post intervention in average distance travelled per day measured via the Fitbit
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph physical activity intensity
Mean change from pre to post intervention in time spent in different physical activity intensities (sedentary, light, moderate-vigorous and vigorous) measured by the Actigraph
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit physical activity intensity
Mean change from pre to post intervention in time spent in different physical activity intensities (sedentary, light, moderate-vigorous and vigorous) measured by the Fitbit
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: sedentary bouts
Mean change from pre to post intervention in number of sedentary bouts per day measured via the Actigraph
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: body position
Mean change from pre to post intervention in time spent in each body position per day measured via the Actigraph
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: active hours
Mean change from pre to post intervention in number of active hours per day measured via the Fitbit
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical activity between pre and post intervention: active minutes
Mean change from pre to post intervention in number of active minutes per day measured via the Fitbit
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Movement ABC
Mean score and percentile ranking measured via on the Movement ABC (a performance measure of physical function)
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: 6 Minute Walk Test
Mean distance travelled measured via on the 6 Minute Walk test (a performance measure of physical fitness)
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Go
Mean time measured via the Timed Up and Go (a performance measure of physical function)
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Down Stairs
Mean time measured via the Timed Up and Down Stairs (a performance measure of physical function)
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor
Mean time and rating for quality of movement measured via the 30 second Chair Stand Test Assessment (a performance measure of physical function)
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor
Mean time and rating for quality of movement measured via the Time to Rise from the Floor Assessment (a performance measure of physical function)
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: self-reported Pediatric Quality of Life Inventory-core generic module
Mean score recorded on the self-reported Pediatric Quality of Life Inventory-core generic module (standardised questionnaire). Items are scored on a 0-100 scale, so that higher scores indicate better health-related quality of life
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: proxy-reported Pediatric Quality of Life Inventory-core generic module
Mean score recorded on the proxy-reported Pediatric Quality of Life Inventory-core generic module (standardised questionnaire). Items are scored on a 0-100 scale, so that higher scores indicate better health-related quality of life
Time frame: Post intervention (on average 8 weeks)
Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: self-reported PedsQL-cancer module
Mean score recorded on the self-reported Pediatric Quality of Life Inventory-cancer module (standardised questionnaire). Items are scored on a 0-100 scale, so that higher scores indicate better health-related quality of life
Time frame: Post intervention (on average 8 weeks)
Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: proxy-reported PedsQL-cancer module
Mean score recorded on the proxy-reported Pediatric Quality of Life Inventory-cancer module (standardised questionnaire). Items are scored on a 0-100 scale, so that higher scores indicate better health-related quality of life
Time frame: Post intervention (on average 8 weeks)
Categorisation and frequency of reported barriers to physical activity
Categorise and collate the frequency of participant reported barriers to physical activity. Data collected during each week of the intervention period
Time frame: Post intervention (on average 8 weeks)
Categorisation and frequency of action plan strategies
Categorise and collate the frequency of action plan items put in place to overcome barriers to physical activity. Data collected during each week of the intervention period
Time frame: Post intervention (on average 8 weeks)
Utility of physical function assessment tools, measured by completeness of assessment data for physical function
The percentage of physical function assessments that were completed
Time frame: Post completion of follow up assessment (on average 10 weeks)
Utility of physical activity assessment tools, measured by completeness of assessment data for physical activity
Percentage of complete Fitbit and Actigraph data days out of total assessment days
Time frame: Post completion of follow up assessment (on average 10 weeks)
Construct validity of physical function measures
Correlation between scores of all physical function measures: Timed up and Go, Movement ABC, Timed Up and Down Stairs, 6 Minute Walk Test, Time to Rise from the Floor
Time frame: Post completion of follow up assessment (on average 10 weeks)
Interpretability of physical function measures
Interpretability assessment of all physical function measures used in the trial: Timed up and Go, Movement ABC, Timed Up and Down Stairs, 6 Minute Walk Test, Time to Rise from the Floor
Time frame: Post completion of follow up assessment (on average 10 weeks)
Responsiveness of physical function measures
Correlation in mean change over two time points between all physical function measures used in the trial: Timed up and Go, Movement ABC, Timed Up and Down Stairs, 6 Minute Walk Test, Time to Rise from the Floor and Global Rating of Change Score
Time frame: Post completion of follow up assessment (on average 10 weeks)
Criterion validity of physical activity measured on the Fitbit and Actigraph
Correlation of physical activity data between Fitbit and Actigraph
Time frame: Post completion of follow up assessment (on average 10 weeks)
Plan to share: Yes — The participants will be asked to voluntarily consent to data sharing. Beginning from 3 months after article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access: * Individual de-identified participant data that underlie the results reported in this article (text, tables, figures and appendices) * Trial protocol, Statistical Analysis Plan, Participant Informed Consent Form
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Murdoch Childrens Research Institute