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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04483362




Registration number
NCT04483362
Ethics application status
Date submitted
14/07/2020
Date registered
23/07/2020
Date last updated
5/10/2020

Titles & IDs
Public title
CanMove: A Physical Activity Program for Children With Cancer
Scientific title
CanMove: The Feasibility of Implementing a Physical Activity Intervention for Children Undergoing Acute Cancer Treatment
Secondary ID [1] 0 0
MurdochCRI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Complex physical activity intervention

Experimental: Physical Activity - Behavioural change techniques to promote physical activity


Behaviour: 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

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Through completion of recruitment, estimated as 9 months
Primary outcome [2] 0 0
Acceptability of the intervention according to participants - Participant and participant guardian perspective on intervention satisfaction and potential areas of improvement via semi-structured interviews
Timepoint [2] 0 0
After completion of the intervention (on average 8 weeks)
Primary outcome [3] 0 0
Acceptability of the intervention according to staff - Staff perspective on intervention satisfaction and potential areas of improvement via focus groups with staff members
Timepoint [3] 0 0
Through study completion, estimated as 1 year
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Post intervention (on average 8 weeks)
Primary outcome [5] 0 0
Implementation of the intervention: attendance to intervention sessions - Adherence to attending intervention sessions, percentage of intervention sessions that were attended
Timepoint [5] 0 0
Post intervention (on average 8 weeks)
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Post intervention (on average 8 weeks)
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Post the participant's final trial visit (on average 12 weeks)
Primary outcome [8] 0 0
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
Timepoint [8] 0 0
Post intervention (on average 8 weeks)
Primary outcome [9] 0 0
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
Timepoint [9] 0 0
Post intervention (on average 8 weeks)
Primary outcome [10] 0 0
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
Timepoint [10] 0 0
Post intervention (on average 8 weeks)
Primary outcome [11] 0 0
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
Timepoint [11] 0 0
Post intervention (on average 8 weeks)
Primary outcome [12] 0 0
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
Timepoint [12] 0 0
Post intervention (on average 8 weeks)
Primary outcome [13] 0 0
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
Timepoint [13] 0 0
Post intervention (on average 8 weeks)
Primary outcome [14] 0 0
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
Timepoint [14] 0 0
Post intervention (on average 8 weeks)
Primary outcome [15] 0 0
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
Timepoint [15] 0 0
Post intervention (on average 8 weeks)
Primary outcome [16] 0 0
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
Timepoint [16] 0 0
Post intervention (on average 8 weeks)
Primary outcome [17] 0 0
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
Timepoint [17] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Post intervention (on average 8 weeks)
Secondary outcome [12] 0 0
Utility of physical function assessment tools, measured by completeness of assessment data for physical function - The percentage of physical function assessments that were completed
Timepoint [12] 0 0
Post completion of follow up assessment (on average 10 weeks)
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Post completion of follow up assessment (on average 10 weeks)

Eligibility
Key inclusion criteria
- Is between the ages of 5-17 years at the time of consent

- Diagnosed (or relapsed) with cancer >4 weeks and <6 months at time of consent

- Currently receiving cancer treatment at the Royal Children's Hospital

- Has been an in-patient for >7 consecutive days at the time of consent

- Provide a signed and dated informed consent form and/or has a legally acceptable
representative capable of understanding the informed consent document and providing
consent on the participant's behalf
Minimum age
5 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Deemed by the treating medical team as unsafe to participate

- Child/adolescent unable to mobilise independent of clinical staff assistance, as
classified by the research team at the time of consent (use of a gait aid or
assistance from a primary carer/support person is accepted). For example, if a
child/adolescent requires assistance from nursing staff or physiotherapist in order to
walk, they will be excluded.

- Child/adolescent unable to follow simple instructions

- Suitable support person (18 years and over) not available to participate in continuous
monitoring of daily steps in tandem with the child/adolescent

- No suitable access to a device to sync with a Fitbit

- Inability or unwillingness of participant or legally acceptable representative to give
written informed consent.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Victor
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
La Trobe University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04483362
Trial related presentations / publications
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
Public notes

Contacts
Principal investigator
Name 0 0
Sarah L Grimshaw
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah L Grimshaw
Address 0 0
Country 0 0
Phone 0 0
+61 417162166
Fax 0 0
Email 0 0
sarah.grimshaw@mcri.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04483362