CanMove: A Physical Activity Program for Children With Cancer

NCT ID: NCT04483362

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2021-09-03

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.

Conditions

Pediatric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical Activity

Behavioural change techniques to promote physical activity

Group Type: EXPERIMENTAL

Complex physical activity intervention

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

La Trobe University

OTHER

Sponsor Role: collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah L Grimshaw

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

Royal Children's Hospital

Parkville, Victora, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 19362699 (View on PubMed)

Other Identifiers

MurdochCRI

Identifier Type: -

Identifier Source: org_study_id