Clinical trial · Interventional
Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer
Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer (SPARK)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Physical activity and play in early childhood are positively associated with healthy growth and gross motor, social, and cognitive development. Preschool children with cancer are at risk of impairments or delays in these interdependent developmental areas. Therefore, it is imperative to find new rehabilitation approaches to ensure preschool children's development during and after treatment. This study is based on the RePlay trial, where results highlight a demand from families for physical activity during cancer treatment and show that preschoolers want to participate. However, there is a need for a more flexible and accessible physical activity initiative at the hospital and greater support and collaboration with parents, also at home. The purpose of this randomized controlled study is to investigate the effect of 9 months of physical activity at the hospital and at home for 82 preschool children with cancer, aged 1-5 years. The rehabilitation program includes the following components: 1. Facilitated structured active play as group sessions at the hospital 2. A parent education program 3. Online facilitated structured active play in the families' homes The included children will be randomized to either a group only receiving structured active play at the hospital (part 1), or a group receiving both structured active play at the hospital, the parent education program, and online structured active play in the families' homes (parts 1-3). We will measure the children's in gross motor function 9 months after the start of treatment (primary outcome), as well as parents' attitudes towards physical activity and the children's general physical function (secondary outcomes). We will measure at treatment initiation, and 6, 9, and 12 months after treatment initiation. Additionally, we will qualitatively investigate the parents and children's experiences, the potential of the rehabilitation program for the children's social development, and the importance of the professional in facilitating structured active play.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Pediatric Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Facilitated group-structured active play at the hospital | Behavioral | — | UNRESOLVED |
| Online facilitated structured active play at home | Behavioral | — | UNRESOLVED |
| Parents educational program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm (a)
- description
- The first intervention arm (a) includes standard care and nine months of facilitated group-structured active play at the hospital. Standard care in-cludes occupational therapy and physiotherapy if needed.
- interventionNames
- Behavioral: Facilitated group-structured active play at the hospital
- type
- EXPERIMENTAL
- label
- Intervention arm (b)
- description
- The second intervention arm (b) includes standard care and nine months of facilitated group-structured active play at the hospital combined with a parent educational program and online facilitated structured active play at home. The different intervention components are described in detail below. Standard care includes occupational therapy and physiotherapy if needed.
- interventionNames
- Behavioral: Facilitated group-structured active play at the hospital
- Behavioral: Parents educational program
- Behavioral: Online facilitated structured active play at home
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 71 Months
Show eligibility criteria text
Inclusion Criteria: * Children newly diagnosed with cancer or cancer-like benign disorders. * Children between the ages of ≥12 to \<72 months at the time of treatment initiation. * Children undergoing intravenous chemotherapy and/or radiation therapy and/or immuno-therapy at the Department for Pediatrics and Adolescent Medicine at Copenhagen Univer-sity Hospital-Rigshospitalet. Exclusion Criteria: * Children diagnosed with severe mental or physical disorders that prevent them from follow-ing instructions in relation to the intervention and testing. * Children where neither of the parents/guardians can communicate in Danish without a translator.
References
Publications (20)
- BACKGROUNDNielsen MKF, Christensen JF, Frandsen TL, Thorsteinsson T, Andersen LB, Christensen KB, Wehner PS, Hasle H, Adamsen LO, Schmiegelow K, Larsen HB. Effects of a physical activity program from diagnosis on cardiorespiratory fitness in children with cancer: a national non-randomized controlled trial. BMC Med. 2020 Jul 6;18(1):175. doi: 10.1186/s12916-020-01634-6. PMID 32624004
- BACKGROUNDStahlhut M, Christensen J, Aadahl M. Applicability and intrarespondent reliability of the pediatric evaluation of disability inventory in a random Danish sample. Pediatr Phys Ther. 2010 Summer;22(2):161-9. doi: 10.1097/PEP.0b013e3181dbf965. PMID 20473099
- BACKGROUNDFolio MR, Fewell RR. Peabody Developmental Motor Scales - Second Edition - Examiner's Manual. Second Edi. Austin, TX: PRO-ED; 2000.
- BACKGROUNDKeech JJ, Hatzis D, Kavanagh DJ, White KM, Hamilton K. Parents' role constructions for facilitating physical activity-related behaviours in their young children. Aust J Psychol. 2018;70(3):246-57.
- BACKGROUNDTrost SG, Loprinzi PD. Parental Influences on Physical Activity Behavior in Children and Adolescents: A Brief Review. Am J Lifestyle Med. 2011;5(2):171-81.
- BACKGROUNDGaser D, Peters C, Oberhoffer-Fritz R, Gotte M, Feuchtinger T, Schmid I, Haller B, von Luettichau I, Kesting S. Effects of strength exercise interventions on activities of daily living, motor performance, and physical activity in children and adolescents with leukemia or non-Hodgkin lymphoma: Results from the randomized controlled ActiveADL Study. Front Pediatr. 2022 Nov 8;10:982996. doi: 10.3389/fped.2022.982996. eCollection 2022. PMID 36425395
- BACKGROUNDThorsteinsson T, Schmiegelow K, Thing LF, Andersen LB, Helms AS, Ingersgaard MV, Lindgren LH, Larsen HB. Classmates motivate childhood cancer patients to participate in physical activity during treatment: A qualitative study. Eur J Cancer Care (Engl). 2019 Sep;28(5):e13121. doi: 10.1111/ecc.13121. Epub 2019 Jun 18.