CanMove: A Physical Activity Program for Children With Cancer

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483362
• Other study ID #: MurdochCRI
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: September 3, 2021

Study information

• Verified date: June 2022
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Parkville	Victora

Sponsors (2)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	La Trobe University

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)