CanMove: A Physical Activity Program for Children With Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Cancer
• Intervention / Treatment: Behavioral: Complex physical activity intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victora
    • Parkville, Victora, Australia, 3052
      • Royal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Physical Activity; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	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	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.	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	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	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	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	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	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	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	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	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	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	Post intervention (on average 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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	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	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	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	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	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	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	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	Post completion of follow up assessment (on average 10 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Post completion of follow up assessment (on average 10 weeks)

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: La Trobe University
• Investigators: Principal Investigator: Sarah L Grimshaw, Murdoch Children'S Research Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 9, 2020
• Primary Completion (ACTUAL): September 3, 2021
• Study Completion (ACTUAL): September 3, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (ACTUAL): July 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: physical activity
• Other Study ID Numbers: MurdochCRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: 3 months following publication - until the end of archival period (15 year post-trial completion (TGA) or until child aged 25 years (whichever is the later))
• IPD Sharing Access Criteria: Research projects that have been approved by a Human Research Ethics Committee
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No