Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer

ConditionsPediatric Cancer Pediatric Cancer Patients

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-71

SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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.
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.

Treatment groups

82 Participants

are divided into 2 treatment groups

Group A: Intervention arm (a)Experimental treatment 1 intervention

Group B: Intervention arm (b)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Level of child's function in everyday life

Level of function is measured through parent structured interviews with Pediatric Evaluation of Disability Inventory (PEDI) where parents answer wuestions about their child's function in three domains self-care, mobiliy and social functioning and the child's need for help in the same three domains. The primary endpoint is after nine months.

Time frame

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

Parents' knowledge

We developed a Multiple-Choice Assessment with a one-best-answer format to assess the parent educational program by testing parents' knowledge of physical activity, gross motor development, and structured active play.

Time frame

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

Other outcomes

Qualitative explorations

We expect to conduct additional studies that will include empirical data collected through semi-structured interviews and observations. The empirical data collected will be analyzed and reported in separate articles. The children and the parents will be interviewed (parents through semi-structured interviews and children through informal conversations). Observational fieldwork will be carried out during the intervention. The interviews with parents are done during the intervention. The informal conversations and observations are done throughout the intervention.

Time frame

Throughout the intervention and at post intervention at 9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Danish Cancer Society

Collaborator

Danish Child Cancer Foundation

Collaborator

Source ClinicalTrials.gov

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