NCT07488494

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Aug 2028

First Submitted

Initial submission to the registry

February 6, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

March 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

February 6, 2026

Last Update Submit

March 18, 2026

Conditions

Physical Activity During Cancer Treatment

Keywords

physical activity enhancement

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).

Study Arms (1)

EMPOWER intervention

OTHER

a single arm study

Behavioral: Digital tool for physical activity guidance and follow-upBehavioral: Physical activity guidance

Interventions

Digital tool for physical activity guidance and follow-upBEHAVIORAL

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.

EMPOWER intervention
Physical activity guidanceBEHAVIORAL

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

EMPOWER intervention

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cancer diagnosis at the age of 3 to 6 years

You may not qualify if:

  • No heart disease or neurological condition prohibiting physical activity -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33538309BACKGROUND

Study Design

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

Study Record Dates

First Submitted

February 6, 2026

First Posted

March 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

March 23, 2026

Record last verified: 2026-02