Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer

NCT07213024 | Not Yet Recruiting

• 2 other identifiers: p-2024-17472H-25047770
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Facilitated structured active play as group sessions at the hospital
2. 2.A parent education program
3. 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).

Conditions

Pediatric Cancer; Pediatric Cancer Patients

Keywords

Physical activity; preschool; children; cancer; gross motor function; active play

Outcome Measures

Primary Outcomes (1)

• Gross motor function

  Gross Motor Function is measured with the gross motor function subscale of Peabody Developmental Motor Scales, Third Edition (PDMS-3). PDMS-3 gives a gross motor standard score summed by the standard score from the three gross motor domians; body control, body transport and object control. The primary endpoint is after nine months.

  At treatment initiation (baseline) and 6, 9 (primary end-point), and 12 months (follow-up) after treatment initiation.

Secondary Outcomes (2)

• Level of child's function in everyday life

  At treatment initiation (baseline) and 6, 9 (primary end-point), and 12 months (follow-up) after treatment initiation.

• Parents' knowledge

  At treatment initiation (baseline), pre and post the parent educational program, and 12 months (follow-up) after treatment initiation.

Other Outcomes (1)

• Qualitative explorations

  Throughout the intervention and at post intervention at 9 months

Study Arms (2)

Intervention arm (a)

EXPERIMENTAL

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.

Behavioral: Facilitated group-structured active play at the hospital

Intervention arm (b)

EXPERIMENTAL

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.

Behavioral: Facilitated group-structured active play at the hospital; Behavioral: Parents educational program; Behavioral: Online facilitated structured active play at home

Interventions

Facilitated group-structured active play at the hospital BEHAVIORAL

The hospital-based part of the intervention includes daily facilitated group-structured active play sessions during the weekdays (i.e., Monday-Friday) at the hospital for 40 weeks. All sessions will be 45 minutes long and structured using the RePlay Model following four core principles: 1) ritual practices; 2) reinforcement of movement through repetition; 3) devel-opment through appropriate challenges; and 4) adjusting activities to accommodate treat-ment-related side effects. All activities are performed together, where healthcare pro-fessionals, parents, and children all participate to support social development. The group-structured active play sessions will take place at the pediatric oncology ward and will be facilitated by a health professional (i.e., an exercise professional or physiother-apist).

Intervention arm (a); Intervention arm (b)

Parents educational program BEHAVIORAL

The parent educational program consists of two educational sessions within the first three months of the child's treatment trajectory. The sessions have the aim of providing the par-ents with knowledge and skills to facilitate structured active play at home: 1. A 30-60-minute session with general information on gross motor function development, common physical side effects of cancer treatment, and the importance of physical activity and active play. 2. A 60-minute practical, interactive introduction to structured active play and the RePlay Model - including inspiration for active play activities they can do at home that challenge different gross motor skills. The parents will receive practical material on gross motor development stages and skills as well as descriptions of active play activities that target gross motor functions.

Intervention arm (b)

Online facilitated structured active play at home BEHAVIORAL

The online facilitated structured active play sessions at home are provided daily during the weekdays (i.e., Monday-Friday) in the afternoon (e.g., 16.00-17.00). A healthcare profes-sional (i.e., an exercise professional or physiotherapist) facilitates these sessions, guiding the families through active play activities following the RePlay Model structure. When the families log on for the online sessions, a healthcare professional will instruct them through different play activities. Each family will receive basic essential home-structured active play equipment (e.g., bean bags, balls, bingo games, items for an obstacle course) for the online sessions. The sessions will be conducted through video connections (Teams or Skype). Families who do not have an iPad or suitable computer will receive an iPad from the research group for the nine-month intervention.

Intervention arm (b)

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator
• Danish Child Cancer Foundation: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (20)

• Nielsen 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 BACKGROUND

• Stahlhut 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 BACKGROUND

• Folio MR, Fewell RR. Peabody Developmental Motor Scales - Second Edition - Examiner's Manual. Second Edi. Austin, TX: PRO-ED; 2000.

  BACKGROUND

• Keech 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.

  BACKGROUND

• Trost 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.

  BACKGROUND

• Gaser 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 BACKGROUND

• Thorsteinsson 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.

  PMID: 31215079 BACKGROUND

• Pouplier A, Fridh MK, Christensen J, Hoyer A, Schmidt-Andersen P, Winther H, Larsen HB. Rehabilitation including structured active play intervention for preschoolers with cancer during treatment: A RePlay qualitative study of parents' experiences. Eur J Oncol Nurs. 2024 Aug;71:102639. doi: 10.1016/j.ejon.2024.102639. Epub 2024 Jun 7.

  PMID: 38878692 BACKGROUND

• Pouplier A, Larsen HB, Christensen J, Schmidt-Andersen P, Winther H, Fridh MK. The rehabilitation including structured active play (RePlay) model: A conceptual model for organizing physical rehabilitation sessions based on structured active play for preschoolers with cancer. Front Pediatr. 2022 Sep 27;10:980257. doi: 10.3389/fped.2022.980257. eCollection 2022.

  PMID: 36238603 BACKGROUND

• Pouplier A, Fridh MK, Christensen J, Ruiz-Molsgaard H, Hoyer A, Schmidt-Andersen P, Winther H, Larsen HB. The potential of structured active play for social and personal development in preschoolers during cancer treatment: A qualitative RePlay study. J Adv Nurs. 2024 Apr;80(4):1607-1618. doi: 10.1111/jan.15923. Epub 2023 Nov 10.

  PMID: 37950393 BACKGROUND

• Pouplier A, Fridh MK, Schmidt-Andersen P, Nielsen AML, Winther H, Christensen J, Larsen HB. Evaluating the feasibility of a rehabilitation intervention including physical activity as structured active play for preschoolers diagnosed with cancer during the first 6 months of treatment-a study based on data from the RePlay trial. Eur J Pediatr. 2025 Aug 6;184(8):533. doi: 10.1007/s00431-025-06350-y.

  PMID: 40764830 BACKGROUND

• Pouplier A, Winther H, Christensen J, Schmidt-Andersen P, Zhang H, Frandsen TL, Schmiegelow K, Fridh MK, Larsen HB. Rehabilitation Including Structured Active Play for Preschoolers With Cancer (RePlay)-Study Protocol for a Randomized Controlled Trial. Front Pediatr. 2022 May 9;10:834512. doi: 10.3389/fped.2022.834512. eCollection 2022.

  PMID: 35615627 BACKGROUND

• Darcy L, Enskar K, Bjork M. Young children's experiences of living an everyday life with cancer - A three year interview study. Eur J Oncol Nurs. 2019 Apr;39:1-9. doi: 10.1016/j.ejon.2018.12.007. Epub 2018 Dec 23.

  PMID: 30850132 BACKGROUND

• Darcy L, Knutsson S, Huus K, Enskar K. The everyday life of the young child shortly after receiving a cancer diagnosis, from both children's and parent's perspectives. Cancer Nurs. 2014 Nov-Dec;37(6):445-56. doi: 10.1097/NCC.0000000000000114.

  PMID: 24406380 BACKGROUND

• De Luca CR, McCarthy M, Galvin J, Green JL, Murphy A, Knight S, Williams J. Gross and fine motor skills in children treated for acute lymphoblastic leukaemia. Dev Neurorehabil. 2013 Jun;16(3):180-7. doi: 10.3109/17518423.2013.771221. Epub 2013 Mar 11.

  PMID: 23477341 BACKGROUND

• Vainionpaa L. Clinical neurological findings of children with acute lymphoblastic leukaemia at diagnosis and during treatment. Eur J Pediatr. 1993 Feb;152(2):115-9. doi: 10.1007/BF02072486.

  PMID: 8444217 BACKGROUND

• Harman JL, Wise J, Willard VW. Early intervention for infants and toddlers: Applications for pediatric oncology. Pediatr Blood Cancer. 2018 May;65(5):e26921. doi: 10.1002/pbc.26921. Epub 2017 Dec 22.

  PMID: 29271555 BACKGROUND

• Carson V, Hunter S, Kuzik N, Wiebe SA, Spence JC, Friedman A, Tremblay MS, Slater L, Hinkley T. Systematic review of physical activity and cognitive development in early childhood. J Sci Med Sport. 2016 Jul;19(7):573-8. doi: 10.1016/j.jsams.2015.07.011. Epub 2015 Jul 10.

  PMID: 26197943 BACKGROUND

• Leonard HC, Hill EL. Review: The impact of motor development on typical and atypical social cognition and language: a systematic review. Child Adolesc Ment Health. 2014 Sep;19(3):163-170. doi: 10.1111/camh.12055. Epub 2014 Feb 8.

  PMID: 32878369 BACKGROUND

• Timmons BW, Leblanc AG, Carson V, Connor Gorber S, Dillman C, Janssen I, Kho ME, Spence JC, Stearns JA, Tremblay MS. Systematic review of physical activity and health in the early years (aged 0-4 years). Appl Physiol Nutr Metab. 2012 Aug;37(4):773-92. doi: 10.1139/h2012-070.

  PMID: 22765840 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hanne B Larsen, PhD, MSc, RN

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Pouplier, PhD, MSc

CONTACT

004528111998; anna.pouplier@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The intervention is a parallel model where the participants are randomized to one of two intervention arms.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 8, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)