Physical Activity During Cancer TreatmentEMPOWERNCT07488494
Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)
A study testing Digital tool for physical activity guidance and follow-up and Physical activity guidance in people with Physical Activity During Cancer Treatment, run by Turku University Hospital.
Trial summary
The study examines the association of digitally provided EMPOWER - exercise intervention on 3-6-year-old child's physical activity (PA), motor performance and quality of life (QoL) during and after cancer treatment. In addition, the factors that influence the feasibility of the intervention will be examined. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Physical Activity During Cancer Treatment
- What is being tested?
- Digital tool for physical activity guidance and follow-up and Physical activity guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cancer diagnosis at the age of 3 to 6 years
Who cannot join
- No heart disease or neurological condition prohibiting physical activity -
About this study
The study examines the association of digitally provided EMPOWER - exercise intervention on 3-6-year-old child's physical activity (PA), motor performance and quality of life (QoL) during and after cancer treatment. In addition, the factors that influence the feasibility of the intervention will be examined. The research is carried out in cooperation with Turku University of Applied Sciences, Turku and Tampere University Hospitals. Cancer treatments significantly reduce the amount of PA of the child impairing the normal motor development. Delay in normal motor development may cause childhood cancer survivors a higher risk of developing adverse health effects in adulthood. Data on children's PA and condition is collected using questionnaires and sensors. In addition, children's motor performance and QoL are examined through tests and questionnaires. The feasibility of the intervention will be examined from the parents and nursing staff through questionnaires and interviews.
Read the detailed description
The previous exercise guidelines for children with cancer indicate that physical activity is advisable during cancer treatments. However, it has been noted that while the effects of exercise interventions on various health variables in children with cancer have been found effective, there is a recognized need to further investigate the barriers of exercise interventions. The research project will gather new empirical data, thus providing opportunities for understand implementation of evidence-based recommendations in the studied context.
The objectives are: 1) to investigate the association of planned technology-enhanced exercise guidance on child's physical activity, motor performance and quality of life during the cancer treatment and 6 and 12 months after the intensive treatment period 2) to investigate, which factors have effect on exercise intervention's acceptability, fidelity, sustainability and feasibility.
In order to reach these objectives, EMPOWER sets the following research questions for itself:
- What factors affect the feasibility and the acceptability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
- What factors affect the degree to which an intervention improving physical activity and motor skills during the cancer treatment on 3-6-year-old children, was implemented as prescribed or intended (Fidelity)
- What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
- What is the association of intervention on physical activity and motor performance of children aged 3-6 years?
- What is the association of intervention on daily condition, and quality of life of children aged 3-6 years? This study addresses the following main hypothesis: Physical exercise during cancer treatment enables a child to keep PA level and motor performance age-appropriate at the end of cancer treatment. Another hypothesis is that support and guidance to the nursing staff and care givers on the significance of and methods of implementing the PA intervention, will enhance the intervention's fidelity and acceptability, feasibility and sustainability. Additionally, a hypothesis is that feedback on the child's condition during the treatment period will encourage and help the child and her guardians to implement the PA intervention during treatment. A further hypothesis is that physical exercise will not worsen the child's condition and quality of life during and after cancer treatment but might even promote them.
- Being tested
- Digital tool for physical activity guidance and follow-up, Physical activity guidance
- Keywords
- physical activity enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital tool for physical activity guidance and follow-upBehavioural
Intervention length applied in this study varies according to participants cancer type and treatment period from 6 to 12 months. The intervention is carried out by mixed supervision. During the hospital visits supervision is carried out by experienced exercise physiotherapist together with the parents. During the home periods the supervision is carried out by EMPOWER mobile user interface.
The recommended minimum three hours of PA a day for children consist of age appropriate activities of different ranges of intensity: 2 hours of light or brisk physical activity and one hour vigorous physical activity. Targeted single PA session duration is ≥30 min and the progression of the PA dose (exercise frequency, duration) and especially intensity, is expected to increase gradually up to 3 hours / day considering the child + parent self-evaluated daily condition.
Physical activity guidanceBehavioural
The intervention will be delivered by EMPOWER mobile UI for self reporting as well as guiding parents based on data. The application is adapted from an existing MyE.Way knowledge management system for holistic player development in team sports. EMPOWER mobile UI data collection and guidance system gives daily reminder to the parents about the daily PA recommendation. In addition, the families are provided with educational tips on useful games and activities leading to light, brisk, or vigorous PA. The tips are adjusted so that they can be completed during the cancer treatment either indoors or outdoors. The provided activities include education concerning the safety aspects regarding the child's cancer type and cancer treatment. As part of the intervention, children's daily pain, condition and exercise enjoyment, as well as child's readiness for exercise will be evaluated via the tool
| Study group | Role | What they receive |
|---|---|---|
| EMPOWER intervention | Other | a single arm study Receives: Behavioral: Digital tool for physical activity guidance and follow-up; Behavioral: Physical activity guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface.
Child's physical activity is measured daily by using the mobile EMPOWER user interface over the intervention. This tool has been created by Turku University of applied sciences for this study.
Measured: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Age-appropriate motor skills are measured by Movement ABC measuring system
Motor skills are tested using Movement ABC-measuring system (version 3) monthly up to 3 months ande there after every 3 months (depending on the length of child's cancer treatment.
Measured: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Quality of life of the child is measured by internationally validated Pedatric Quality of Life Inventory (PedsQoL)
Quality of life of the child is measured by using age-appropriate Generic Core scales of PedsQoL parent proxy forms.
Measured: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Fibion SENS device is used for continuous measuring of the child's activity over 7 days.
Fibion SENS activity measurement is performed ovet 7 days all together three times during the whole intervention.
Measured: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Feasibility of using the mobile EMPOWER application is explored by interviewing the parents/caregivers
Parents/caregivers of the participating children are interviewed three times during the study period using semi-structured method developed by the study team.
Measured: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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 Physical Activity During Cancer TreatmentStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Turku University of Applied Sciences, Tampere University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488494
- Sponsor's protocol ID
- 60230
- Other IDs
- 368294
- Acronym
- EMPOWER
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Finnish legislation does not allow person level data to be delivered outside the study group
Publications
Wurz A, McLaughlin E, Lategan C, Ellis K, Culos-Reed SN. Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). Transl Behav Med. 2021 Apr 7;11(3):699-708. doi: 10.1093/tbm/ibaa136.
PubMed 33538309
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)
- ClinicalTrials.gov ID
- NCT07488494
- Acronym / sponsor ID
- EMPOWER / 60230
- Keywords
- physical activity enhancement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Turku University of Applied Sciences, Tampere University Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 23 Mar 2026 (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.
The study examines the association of digitally provided EMPOWER - exercise intervention on 3-6-year-old child's physical activity (PA), motor performance and quality of life (QoL) during and after cancer treatment. In addition, the factors that influence the feasibility of the intervention will be examined. The research is carried out in cooperation with Turku University of Applied Sciences, Turku and Tampere University Hospitals. Cancer treatments significantly reduce the amount of PA of the child impairing the normal motor development. Delay in normal motor development may cause childhood cancer survivors a higher risk of developing adverse health effects in adulthood. Data on children's PA and condition is collected using questionnaires and sensors. In addition, children's motor performance and QoL are examined through tests and questionnaires. The feasibility of the intervention will be examined from the parents and nursing staff through questionnaires and interviews.
Detailed description
The previous exercise guidelines for children with cancer indicate that physical activity is advisable during cancer treatments. However, it has been noted that while the effects of exercise interventions on various health variables in children with cancer have been found effective, there is a recognized need to further investigate the barriers of exercise interventions. The research project will gather new empirical data, thus providing opportunities for understand implementation of evidence-based recommendations in the studied context.
The objectives are: 1) to investigate the association of planned technology-enhanced exercise guidance on child's physical activity, motor performance and quality of life during the cancer treatment and 6 and 12 months after the intensive treatment period 2) to investigate, which factors have effect on exercise intervention's acceptability, fidelity, sustainability and feasibility.
In order to reach these objectives, EMPOWER sets the following research questions for itself:
- What factors affect the feasibility and the acceptability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
- What factors affect the degree to which an intervention improving physical activity and motor skills during the cancer treatment on 3-6-year-old children, was implemented as prescribed or intended (Fidelity)
- What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
- What is the association of intervention on physical activity and motor performance of children aged 3-6 years?
- What is the association of intervention on daily condition, and quality of life of children aged 3-6 years? This study addresses the following main hypothesis: Physical exercise during cancer treatment enables a child to keep PA level and motor performance age-appropriate at the end of cancer treatment. Another hypothesis is that support and guidance to the nursing staff and care givers on the significance of and methods of implementing the PA intervention, will enhance the intervention's fidelity and acceptability, feasibility and sustainability. Additionally, a hypothesis is that feedback on the child's condition during the treatment period will encourage and help the child and her guardians to implement the PA intervention during treatment. A further hypothesis is that physical exercise will not worsen the child's condition and quality of life during and after cancer treatment but might even promote them.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMPOWER intervention | Other | Behavioral: Digital tool for physical activity guidance and follow-up, Behavioral: Physical activity guidancea single arm study |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Cancer diagnosis at the age of 3 to 6 years
Key exclusion criteria (1 listed)
- No heart disease or neurological condition prohibiting physical activity -
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 |
|---|---|---|
| Digital tool for physical activity guidance and follow-upIntervention length applied in this study varies according to participants cancer type and treatment period from 6 to 12 months. The intervention is carried out by mixed supervision. During the hospital visits supervision is carried out by experienced exercise physiotherapist together with the parents. During the home periods the supervision is carried out by EMPOWER mobile user interface. The recommended minimum three hours of PA a day for children consist of age appropriate activities of different ranges of intensity: 2 hours of light or brisk physical activity and one hour vigorous physical activity. Targeted single PA session duration is ≥30 min and the progression of the PA dose (exercise frequency, duration) and especially intensity, is expected to increase gradually up to 3 hours / day considering the child + parent self-evaluated daily condition. | Behavioural | EMPOWER intervention |
| Physical activity guidanceThe intervention will be delivered by EMPOWER mobile UI for self reporting as well as guiding parents based on data. The application is adapted from an existing MyE.Way knowledge management system for holistic player development in team sports. EMPOWER mobile UI data collection and guidance system gives daily reminder to the parents about the daily PA recommendation. In addition, the families are provided with educational tips on useful games and activities leading to light, brisk, or vigorous PA. The tips are adjusted so that they can be completed during the cancer treatment either indoors or outdoors. The provided activities include education concerning the safety aspects regarding the child's cancer type and cancer treatment. As part of the intervention, children's daily pain, condition and exercise enjoyment, as well as child's readiness for exercise will be evaluated via the tool | Behavioural | EMPOWER intervention |
Primary outcome
Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface.
Time frame: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Child's physical activity is measured daily by using the mobile EMPOWER user interface over the intervention. This tool has been created by Turku University of applied sciences for this study.
Age-appropriate motor skills are measured by Movement ABC measuring system
Time frame: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Motor skills are tested using Movement ABC-measuring system (version 3) monthly up to 3 months ande there after every 3 months (depending on the length of child's cancer treatment.
Quality of life of the child is measured by internationally validated Pedatric Quality of Life Inventory (PedsQoL)
Time frame: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Quality of life of the child is measured by using age-appropriate Generic Core scales of PedsQoL parent proxy forms.
Fibion SENS device is used for continuous measuring of the child's activity over 7 days.
Time frame: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Fibion SENS activity measurement is performed ovet 7 days all together three times during the whole intervention.
Feasibility of using the mobile EMPOWER application is explored by interviewing the parents/caregivers
Time frame: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Parents/caregivers of the participating children are interviewed three times during the study period using semi-structured method developed by the study team.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 33538309Wurz A, McLaughlin E, Lategan C, Ellis K, Culos-Reed SN. Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). Transl Behav Med. 2021 Apr 7;11(3):699-708. doi: 10.1093/tbm/ibaa136.
- Individual participant dataSharing planned: Undecided. Finnish legislation does not allow person level data to be delivered outside the study group
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Digital tool for physical activity guidance and follow-up and Physical activity guidance in people with Physical Activity During Cancer Treatment, run by Turku University Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface. (time frame: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).). The study lists 5 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 NCT07488494, 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 23 Mar 2026.