CanMove: A Physical Activity Program for Children With Cancer

NCT04483362 | Completed

• 1 other identifier: MurdochCRI
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

physical activity

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (14)

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

  Post intervention (on average 8 weeks)

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

  Post intervention (on average 8 weeks)

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

  Post intervention (on average 8 weeks)

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

  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

  Post intervention (on average 8 weeks)

Other Outcomes (4)

• Construct validity of physical function measures

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

• Interpretability of physical function measures

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

• Responsiveness of physical function measures

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

Study Arms (1)

Physical Activity

EXPERIMENTAL

Behavioural change techniques to promote physical activity

Behavioral: Complex physical activity intervention

Interventions

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

Physical Activity

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• La Trobe University: collaborator

Study Sites (1)

Royal Children's Hospital

Parkville, Victora, 3052, Australia

Location

Related 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.

  PMID: 19362699 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sarah L Grimshaw

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 23, 2020
• Study Start: November 9, 2020
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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))
• Access Criteria: Research projects that have been approved by a Human Research Ethics Committee

Locations

AU (1)