Rehabilitation Including Play and Movement Activities for Preschool Children With Cancer.
Rehabilitation Including Play and Movement Activities for Preschool Children With Cancer.
Treatment for childhood cancer causes treatment-related acute adverse events such as muscle
 weakness and physical incompetence. With long admissions, isolation, and long-term bed rest,
 this means reduced physical activity and, ultimately, gross motor functioning development is
 affected. Furthermore, the children participate less in sport and leisure activities,
 inhibiting social skills, and the children feel isolated from peers. The above makes it
 difficult for children to return to everyday activities. Physical activity in the form of
 play and movement activities is essential for preschool children's gross motor, social, and
 personal development- a development where parents play a crucial role.

 Replay is a randomized controlled trial that will include 84 children with cancer aged 1-5
 years at the University Hospital Copenhagen, Rigshospitalet. The children are included at the
 treatment initiation and are randomized to either the intervention group or the control
 group. The intervention consists of six months of daily structured play-based physical
 activity, including daily parent administered play and movement and three weekly group-based
 play and movement sessions at the hospital during admissions. Gross motor and physical
 function is measured with 1) Peabody Developmental Motor Scales, Second Edition (PDMS-2),
 Pediatric Evaluation of Disability Inventory (PEDI), Handgrip strength, and a six-minute walk
 test. The assessment time points are baseline (initiated timepoint), 3- and 6 months
 (endpoint) after initiated treatment. The intervention group will be observed and invited to
 participate in qualitative interviews. The control group will receive usual care and specific
 physiotherapy if needed.
Aim

 Project RePlay aims to investigate the effectiveness of a play-based physical activity
 intervention on gross motor functioning measured by Peabody Developmental Motor Scales,
 Second Edition (PDMS-2) with the primary end-point six months after diagnosis in children
 with newly diagnosed cancer aged 1-5 years old. The investigators hypothesize that the
 intervention will reduce short- and long-term physical and psychosocial consequences,
 including reduced gross motor function and lack of social interaction.

 1. Background

 Physical play and movement activities are essential for preschool children's gross
 motor, social, and personal development. Through play and movement, children develop
 motor skills crucial for participation in physical and social activities throughout
 life. A study showed that an 18-week play intervention among healthy preschool children
 significantly improved (p<.0005) gross motor function in the intervention group compared
 with the control group. Play is also the children's first arena for socializing, and
 these interactions have an immense role in developing emotional, personal, and social
 skills. Physical play and movement activities are more than just physical exercise; it
 is social teamwork, emotions, and learning. Reduced physical activity or inactivity in
 children is highly dependent on three factors; 1) reduced dynapenia (muscle strength and
 power), 2) exercise deficit disorder (physical inactivity), and 3) physical illiteracy
 (reduced competence, confidence, and knowledge in movement). Due to more intensive
 treatment with chemotherapy, radiation, and surgery, children with cancer experience
 acute adverse events such as myopathy and neuropathy, resulting in muscle weakness,
 physical incompetence, and inactivity. Furthermore, treatment-related complications such
 as infections can cause extended periods of hospitalization, periods of isolation, and
 long-term bed rest. Thus, many children with cancer experience several physical side
 effects as impaired motor skills, physical capacity, and decreased motivation to engage
 in physical activity. The cancer treatment has a significant impact on the children's
 physical development and socialization as the lack of motor development leads to
 inactivity and less participation in sport and leisure activities. This leads to a
 reduced understanding of the social playing field in joint activities, and the children
 feel more isolated from peers. Children with cancer experiences challenges in all three
 factors leading to physical inactivity. Compared with siblings and the general
 population, these social and physical challenges persist for the rest of their lives.
 Hence, children diagnosed with cancer have lower school performance, lower education
 level, higher unemployment, and increased socioeconomic challenges. Thus, the
 investigators hypothesize that early initiated rehabilitation programs during initial
 treatment, focusing on maintaining a typical physical activity level, are crucial for
 continuing everyday activities during and after treatment.

 The rehabilitation, including social and physical activity and education in children and
 teenagers with cancer (RESPECT) study for children with cancer aged 6-18 years, showed
 that it is feasible to carry out physical tests and motivate them to participate in
 physical activities. Physical activity maintained the hospitalized children's physical
 fitness and gross motor function during treatment compared with hospitalized children
 who did not receive physical activity intervention. A systematic review covering
 international studies show similar findings; that physical activities positively affect
 mobility, physical fitness, muscle strength, and quality of life in children with
 cancer. Additionally, children with cancer who participate in structured physical
 activities during treatment have fewer admission days than children who received
 standard care, corresponding to a 17% reduction in hospitalization's total economic
 cost. Most studies focusing on physical activity as part of an early initiated
 rehabilitation program designed interventions for school children aged 6-18. Only a few
 of the studies include children under the age of 6 years. Each year 200 children and
 adolescents aged 0-18 years are diagnosed with cancer in Denmark. Of these,
 approximately one-third is diagnosed before the age of 5. None of the published studies
 on physical activity in pediatric oncology designed interventions for preschool children
 (1-5 years old). Thus, there is a lack of studies with an intervention designed for
 preschool children with cancer focusing on physical and social rehabilitation.
 Improvements in cure-rates of childhood cancer mean that today's 5-year survival is 85%.
 Thus, more research into the best strategies for physical activity and rehabilitation
 for all age groups of children with cancer is needed.

 A single study of parent-controlled physical activity at home included children with
 cancer from age 1-17. The intervention didn't improve the children's motor function
 compared with the control group, mainly due to poor adherence to the intervention.
 Project RESPECT shows that motivation and adherence to physical activity interventions
 are dependent on the support from "significant others" such as parents and exercise
 professionals. Parents are an essential resource for children with cancer. The parents
 follow the child's treatment closely, and the parents' support throughout the treatment
 is crucial for the child's need for presence and support so the child can feel safe and
 in control. Furthermore, the focus on home-based care is increasing to minimize hospital
 visits. Consequently, parents play an essential role in physical activity and
 rehabilitation for children with cancer. For preschool children, the parents' role is
 even more essential. When small children and parents play together, it creates a unique
 and safe environment where the children can be challenged physically and socially.
 Children's development is dependent on parents, and parents of a child with cancer must
 acquire the necessary skills concerning play and movement for the child.

 With project RePlay, the aim is to develop prophylactic strategies by investigating a
 play-based physical activity intervention for children with cancer aged 1-5 years to
 ensure the retention of natural motor and social development and participation in
 everyday activities. The hypothesis is that individual and social play and movement
 activities, with parents as resources, can reduce gross motor and social development
 impairments. Thus, the objectives of RePlay are:

 -  To investigate the effects of a six-month play-based physical activity intervention
 in children with cancer, aged 1-5 years on gross motor function compared with a
 control group receiving usual care.

 -  To investigate the children with cancer and the parents' experiences with a
 play-based physical activity intervention during treatment and the influence on the
 children's social and personal development.

 2. Research plan

 Design:

 The randomized controlled trial study takes place at the Department of Pediatric
 Hematology/Oncology at Rigshospitalet. RePlay will include 84 children aged 1-5 years
 diagnosed with cancer. The children are randomized to either the intervention- or control
 group after the children have performed the baseline testing. The children will be stratified
 by age at inclusion (respectively, over and under three years old) and treatment group
 (hematologic malignancy, solid tumors, CNS-tumors). The intervention group will participate
 in a six-month play-based physical activity intervention starting from initiated treatment.
 The study will be an open-ended cohort where newly diagnosed patients are included on an
 ongoing basis.

 The intervention will consist of 45 min daily play-based physical activities inspired by
 Mighty Moves from the study of Bellows et al. [5], where the activities are playful and focus
 on gross motor skills. The intervention combines hospital and home-based physical activity.
 Three days a week, there will be 45 minutes of group-based physical activity at the hospital
 for the children, siblings, and parents during admissions or appointments at the outpatient
 clinic. An exercise professional or pediatric physiotherapist administers the group-based
 sessions at the hospital. Children isolated in the hospital room are offered individual
 sessions as a substitute for the group-based sessions.

 During the other four days a week or on days where the family is at home, the parents
 administer the play-based physical activity. The parents receive education and supervision on
 conducting play-based physical activity with their child in the hospital room or at home. The
 parents will receive inspiration material containing numerous different plays, games, and
 activities in different intensities, ensuring that their child is physically active every day
 with different intensity. The material is designed to engage the child in choosing what
 activities to do.

 Due to age-specific development and movement, the children in the intervention group are
 split into two groups for the group-based sessions:

 • Tumble: 1-2 years old • Tumble turbo: 3-5 years old

 An example of a weekly schedule:

 Monday: parent administered play

 Tuesday: parents administered play OR group-based session at the hospital

 Wednesday: parent administered play

 Thursday: parents administered play OR group-based session at the hospital

 Friday: parents administered play OR group-based session at the hospital

 Saturday: parents administered play

 Sunday: parents administered play

 The control group will receive standard treatment and physiotherapy if needed. After six
 months of treatment, the child and parents will receive a status on the child's motor
 development and be invited to receive individual instructions and invited to participate in
 the social sessions.

 Sample size:

 Since there is no evidence on the potential effect of gross motor function in children with
 cancer, the sample size is estimated based on Bellows et al.'s (2013). The study objective
 was to research the potential of a play intervention on gross motor function in healthy
 preschool children measured by Peabody Developmental Motor Scales, Second Edition (PDMS-2).
 The sample size is estimated with an Alpha = 0,05 and Power = 80%. Based on a mean (SD) in
 the interventions group = 99,31 (9,07) and a mean (SD) in the control group = 93,24, n=70 (35
 intervention group; 35 control group) are to be included. Assuming a 20% dropout rate, RePlay
 will include 84 children.
Inclusion Criteria:

 -  Children diagnosed with cancer or benign disorders and are being treated with
 chemotherapy and/or radiation and are admitted to the Department of Pediatric
 Hematology/Oncology at University Hospital Copenhagen, Rigshospitalet.

 -  Children at the age of 1-5 years at diagnosis.

 -  Children whose parents can communicate in Danish.

 Exclusion Criteria:

 -  Children with mental disabilities that complicates the ability to follow instructions.