Clinical trial NCT04483362: CanMove: A Physical Activity Program for Children With Cancer
Official title: CanMove: The Feasibility of Implementing a Physical Activity Intervention for Children Undergoing Acute Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: physical activity
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: La Trobe University
First posted: 2020-07-23
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Demand for the intervention
timeFrame: Through completion of recruitment, estimated as 9 months
measure: Acceptability of the intervention according to participants
timeFrame: After completion of the intervention (on average 8 weeks)
measure: Acceptability of the intervention according to staff
timeFrame: Through study completion, estimated as 1 year
measure: Implementation of the intervention: adherence to wearing Fitbit
timeFrame: Post intervention (on average 8 weeks)
measure: Implementation of the intervention: attendance to intervention sessions
timeFrame: Post intervention (on average 8 weeks)
measure: Implementation of the intervention: ability for participants to attain their steps per day goal
timeFrame: Post intervention (on average 8 weeks)
measure: Practicality of the intervention: adverse events
timeFrame: Post the participant's final trial visit (on average 12 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph steps per day
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit steps per day
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph distance travelled per day
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit distance travelled per day
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph physical activity intensity
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit physical activity intensity
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: sedentary bouts
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: body position
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: active hours
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical activity between pre and post intervention: active minutes
timeFrame: Post intervention (on average 8 weeks)
Secondary outcomes:
measure: Limited efficiency testing assessing changes in physical function from pre to post intervention: Movement ABC
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical function from pre to post intervention: 6 Minute Walk Test
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Go
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Down Stairs
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor
timeFrame: Post intervention (on average 8 weeks)
measure: Limited efficiency testing assessing changes in physical function from pre to post intervention: Time to Rise from the Floor
timeFrame: Post intervention (on average 8 weeks)
measure: 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
timeFrame: Post intervention (on average 8 weeks)
measure: 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
timeFrame: Post intervention (on average 8 weeks)
measure: Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: self-reported PedsQL-cancer module
timeFrame: Post intervention (on average 8 weeks)
measure: Feasibility: Limited efficiency testing assessing changes in Health-related Quality of Life from pre to post intervention: proxy-reported PedsQL-cancer module
timeFrame: Post intervention (on average 8 weeks)
measure: Categorisation and frequency of reported barriers to physical activity
timeFrame: Post intervention (on average 8 weeks)
measure: Categorisation and frequency of action plan strategies
timeFrame: Post intervention (on average 8 weeks)
measure: Utility of physical function assessment tools, measured by completeness of assessment data for physical function
timeFrame: Post completion of follow up assessment (on average 10 weeks)
measure: Utility of physical activity assessment tools, measured by completeness of assessment data for physical activity
timeFrame: Post completion of follow up assessment (on average 10 weeks)
Other outcomes:
measure: Construct validity of physical function measures
timeFrame: Post completion of follow up assessment (on average 10 weeks)
measure: Interpretability of physical function measures
timeFrame: Post completion of follow up assessment (on average 10 weeks)
measure: Responsiveness of physical function measures
timeFrame: Post completion of follow up assessment (on average 10 weeks)
measure: Criterion validity of physical activity measured on the Fitbit and Actigraph
timeFrame: Post completion of follow up assessment (on average 10 weeks)
Locations:
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victora
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Sarah L Grimshaw
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.