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Completed

NCT Number: NCT04483362

CanMove: A Physical Activity Program for Children With Cancer

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.

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Key information

Conditions

Pediatric Cancer Behavior Motor Activity Neoplasms

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Children's Hospital

Parkville, Victora, 3052, Australia

About this study

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:

  • Acceptability: To what extent is a new idea, program, process or measure judged as suitable or satisfying
  • Demand: To what extent is a new idea, program, process, or measure likely to be used
  • Implementation: To what extent can a new program is successfully delivered to intended participants
  • Practicality: To what extent can the program can be carried out with intended participants using existing means, resources, and circumstances
  • Limited efficiency: Does the a new program show promise of being successful with the intended population

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Complex physical activity intervention

Behavioral

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

Primary outcomes

  1. Demand for the intervention

    Time frame: Through completion of recruitment, estimated as 9 months

    Recruitment rate (comparing the number of people recruited to the number of potentially eligible participants), and documenting the reasons for non-participation.

  2. Acceptability of the intervention according to participants

    Time frame: After completion of the intervention (on average 8 weeks)

    Participant and participant guardian perspective on intervention satisfaction and potential areas of improvement via semi-structured interviews

  3. Acceptability of the intervention according to staff

    Time frame: Through study completion, estimated as 1 year

    Staff perspective on intervention satisfaction and potential areas of improvement via focus groups with staff members

  4. Implementation of the intervention: adherence to wearing Fitbit

    Time frame: Post intervention (on average 8 weeks)

    Adherence to wearing the Fitbit for monitoring, percentage of complete Fitbit data days out of total intervention days

  5. Implementation of the intervention: attendance to intervention sessions

    Time frame: Post intervention (on average 8 weeks)

    Adherence to attending intervention sessions, percentage of intervention sessions that were attended

  6. Implementation of the intervention: ability for participants to attain their steps per day goal

    Time frame: Post intervention (on average 8 weeks)

    Goal attainment, percentage of days out of total intervention days that participant was able to achieve their steps per day target

  7. Practicality of the intervention: adverse events

    Time frame: Post the participant's final trial visit (on average 12 weeks)

    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.

  8. Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph steps per day

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in average steps taken per day measured via the Actigraph

  9. Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit steps per day

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in average steps taken per day measured via the Fitbit

  10. Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph distance travelled per day

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in average distance travelled per day measured via the Actigraph

  11. Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit distance travelled per day

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in average distance travelled per day measured via the Fitbit

  12. Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph physical activity intensity

    Time frame: Post intervention (on average 8 weeks)

    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

  13. Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit physical activity intensity

    Time frame: Post intervention (on average 8 weeks)

    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

  14. Limited efficiency testing assessing changes in physical activity between pre and post intervention: sedentary bouts

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in number of sedentary bouts per day measured via the Actigraph

  15. Limited efficiency testing assessing changes in physical activity between pre and post intervention: body position

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in time spent in each body position per day measured via the Actigraph

  16. Limited efficiency testing assessing changes in physical activity between pre and post intervention: active hours

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in number of active hours per day measured via the Fitbit

  17. Limited efficiency testing assessing changes in physical activity between pre and post intervention: active minutes

    Time frame: Post intervention (on average 8 weeks)

    Mean change from pre to post intervention in number of active minutes per day measured via the Fitbit

Secondary outcomes

  1. Limited efficiency testing assessing changes in physical function from pre to post intervention: Movement ABC

    Time frame: Post intervention (on average 8 weeks)

    Mean score and percentile ranking measured via on the Movement ABC (a performance measure of physical function)

  2. Limited efficiency testing assessing changes in physical function from pre to post intervention: 6 Minute Walk Test

    Time frame: Post intervention (on average 8 weeks)

    Mean distance travelled measured via on the 6 Minute Walk test (a performance measure of physical fitness)

  3. Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Go

    Time frame: Post intervention (on average 8 weeks)

    Mean time measured via the Timed Up and Go (a performance measure of physical function)

  4. Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Down Stairs

    Time frame: Post intervention (on average 8 weeks)

    Mean time measured via the Timed Up and Down Stairs (a performance measure of physical function)

  5. Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor

    Time frame: Post intervention (on average 8 weeks)

    Mean time and rating for quality of movement measured via the 30 second Chair Stand Test Assessment (a performance measure of physical function)

  6. Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor

    Time frame: Post intervention (on average 8 weeks)

    Mean time and rating for quality of movement measured via the Time to Rise from the Floor Assessment (a performance measure of physical function)

  7. 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

    Time frame: Post intervention (on average 8 weeks)

    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

  8. 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

    Time frame: Post intervention (on average 8 weeks)

    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

  9. Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: self-reported PedsQL-cancer module

    Time frame: Post intervention (on average 8 weeks)

    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

  10. Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: proxy-reported PedsQL-cancer module

    Time frame: Post intervention (on average 8 weeks)

    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

  11. Categorisation and frequency of reported barriers to physical activity

    Time frame: Post intervention (on average 8 weeks)

    Categorise and collate the frequency of participant reported barriers to physical activity. Data collected during each week of the intervention period

  12. Categorisation and frequency of action plan strategies

    Time frame: Post intervention (on average 8 weeks)

    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

  13. Utility of physical function assessment tools, measured by completeness of assessment data for physical function

    Time frame: Post completion of follow up assessment (on average 10 weeks)

    The percentage of physical function assessments that were completed

  14. Utility of physical activity assessment tools, measured by completeness of assessment data for physical activity

    Time frame: Post completion of follow up assessment (on average 10 weeks)

    Percentage of complete Fitbit and Actigraph data days out of total assessment days

Other outcomes

  1. Construct validity of physical function measures

    Time frame: Post completion of follow up assessment (on average 10 weeks)

    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

  2. Interpretability of physical function measures

    Time frame: Post completion of follow up assessment (on average 10 weeks)

    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

  3. Responsiveness of physical function measures

    Time frame: Post completion of follow up assessment (on average 10 weeks)

    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

  4. Criterion validity of physical activity measured on the Fitbit and Actigraph

    Time frame: Post completion of follow up assessment (on average 10 weeks)

    Correlation of physical activity data between Fitbit and Actigraph

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • La Trobe University

Registry information

Official study title

CanMove: The Feasibility of Implementing a Physical Activity Intervention for Children Undergoing Acute Cancer Treatment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2020
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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