Pediatric CancerNCT04483362
CanMove: A Physical Activity Program for Children With Cancer
A study testing Complex physical activity intervention in people with Pediatric Cancer, run by Murdoch Childrens Research Institute at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Complex physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Nov 2020to 3 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Complex physical activity intervention
- Keywords
- physical activity
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex physical activity interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Behavioural change techniques to promote physical activity Receives: Behavioral: Complex physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post intervention (on average 8 weeks)
Secondary outcomes (14)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post completion of follow up assessment (on average 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start9 Nov 2020
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- La Trobe University
- Responsible party
- Sponsor
- Investigators
- Sarah L Grimshaw, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483362
- Sponsor's protocol ID
- MurdochCRI
- Status last verified
- Jun 2022
- First submitted
- 14 Jul 2020
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 19362699
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CanMove: The Feasibility of Implementing a Physical Activity Intervention for Children Undergoing Acute Cancer Treatment
- ClinicalTrials.gov ID
- NCT04483362
- Acronym / sponsor ID
- MurdochCRI
- Conditions
- Pediatric Cancer
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- La Trobe University
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Complex physical activity interventionBehavioural change techniques to promote physical activity |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex physical activity interventionStructured 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 | Behavioural | Physical Activity |
Primary outcome
Demand for the intervention
Time frame: Through completion of recruitment, estimated as 9 months
Recruitment rate (comparing the number of people recruited to the number of potentially eligible participants), and documenting the reasons for non-participation.
Acceptability of the intervention according to participants
Time frame: After completion of the intervention (on average 8 weeks)
Participant and participant guardian perspective on intervention satisfaction and potential areas of improvement via semi-structured interviews
Acceptability of the intervention according to staff
Time frame: Through study completion, estimated as 1 year
Staff perspective on intervention satisfaction and potential areas of improvement via focus groups with staff members
Implementation of the intervention: adherence to wearing Fitbit
Time frame: Post intervention (on average 8 weeks)
Adherence to wearing the Fitbit for monitoring, percentage of complete Fitbit data days out of total intervention days
Implementation of the intervention: attendance to intervention sessions
Time frame: Post intervention (on average 8 weeks)
Adherence to attending intervention sessions, percentage of intervention sessions that were attended
Implementation of the intervention: ability for participants to attain their steps per day goal
Time frame: Post intervention (on average 8 weeks)
Goal attainment, percentage of days out of total intervention days that participant was able to achieve their steps per day target
Practicality of the intervention: adverse events
Time frame: Post the participant's final trial visit (on average 12 weeks)
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.
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph steps per day
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average steps taken per day measured via the Actigraph
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit steps per day
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average steps taken per day measured via the Fitbit
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph distance travelled per day
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average distance travelled per day measured via the Actigraph
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit distance travelled per day
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in average distance travelled per day measured via the Fitbit
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Actigraph physical activity intensity
Time frame: Post intervention (on average 8 weeks)
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
Limited efficiency testing assessing changes in physical activity between pre and post intervention: Fitbit physical activity intensity
Time frame: Post intervention (on average 8 weeks)
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
Limited efficiency testing assessing changes in physical activity between pre and post intervention: sedentary bouts
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in number of sedentary bouts per day measured via the Actigraph
Limited efficiency testing assessing changes in physical activity between pre and post intervention: body position
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in time spent in each body position per day measured via the Actigraph
Limited efficiency testing assessing changes in physical activity between pre and post intervention: active hours
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in number of active hours per day measured via the Fitbit
Limited efficiency testing assessing changes in physical activity between pre and post intervention: active minutes
Time frame: Post intervention (on average 8 weeks)
Mean change from pre to post intervention in number of active minutes per day measured via the Fitbit
14 secondary outcomes
Limited efficiency testing assessing changes in physical function from pre to post intervention: Movement ABC
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: 6 Minute Walk Test
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Go
Time frame: Post intervention (on average 8 weeks)
Limited efficiency testing assessing changes in physical function from pre to post intervention: Timed Up and Down Stairs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post intervention (on average 8 weeks)
Categorisation and frequency of reported barriers to physical activity
Time frame: Post intervention (on average 8 weeks)
Categorisation and frequency of action plan strategies
Time frame: Post intervention (on average 8 weeks)
Utility of physical function assessment tools, measured by completeness of assessment data for physical function
Time frame: 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
Time frame: Post completion of follow up assessment (on average 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Background: PubMed 19362699Bowen 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Grimshaw principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex physical activity intervention in people with Pediatric Cancer, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand for the intervention (time frame: Through completion of recruitment, estimated as 9 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04483362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.