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document
Study protocol : Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer ( RESPECT ) . BACKGROUND During cancer treatment children have reduced contact with their social network of friends , and have limited participation in education , sports , and leisure activities . During and following cancer treatment , children describe school related problems , reduced physical fitness , and problems related to interaction with peers . METHODS/DESIGN The RESPECT study is a nationwide population-based prospective , controlled , mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark ( n=120 ) and a matched control group in western Denmark ( n=120 ) . RESPECT includes Danish-speaking children diagnosed with cancer and treated at pediatric oncology units in Denmark . Primary endpoints are the level of educational achievement one year after the cessation of first-line cancer therapy , and the value of VO2max one year after the cessation of first-line cancer therapy . Secondary endpoints are quality of life measured by validated questionnaires and interviews , and physical performance . RESPECT includes a multimodal intervention program , including ambassador-facilitated educational , physical , and social interventions . The educational intervention includes an educational program aimed at the child with cancer , the child 's schoolteachers and classmates , and the child 's parents . Children with cancer will each have two ambassadors assigned from their class . The ambassadors visit the child with cancer at the hospital at alternating 2-week intervals and participate in the intervention program . The physical and social intervention examines the effect of early , structured , individualized , and continuous physical activity from diagnosis throughout the treatment period . The patients are tested at diagnosis , at 3 and 6 months after diagnosis , and one year after the cessation of treatment . The study is powered to quantify the impact of the combined educational , physical , and social intervention programs . DISCUSSION RESPECT is the first population-based study to examine the effect of early rehabilitation for children with cancer , and to use healthy classmates as ambassadors to facilitate the normalization of social life in the hospital . For children with cancer , RESPECT contributes to expanding knowledge on rehabilitation that can also facilitate rehabilitation of other children undergoing hospitalization for long-term illness . TRIAL REGISTRATION Clinical Trials.gov : file . NCT01772849 and NCT01772862 .
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Intervention_Educational
Rehabilitation including Social and Physical activity and Education
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Intervention_Educational
multimodal intervention program , including ambassador-facilitated educational , physical , and social interventions .
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Intervention_Educational
educational intervention
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Intervention_Educational
educational program
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Intervention_Pharmacological
visit the child with cancer
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Intervention_Physical
classmates as ambassadors
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Outcome_Physical
level of educational achievement one year after the cessation of first-line cancer therapy , and the value of VO2max one year after the cessation of first-line cancer therapy .
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Outcome_Mental
quality of life measured by validated questionnaires and interviews , and physical performance .
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Participant_Age
Children
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Participant_Age
Teenagers
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Participant_Condition
Cancer
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Participant_Age
children
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Participant_Age
children
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Participant_Age
6-18 years
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Participant_Condition
newly diagnosed with cancer
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Participant_Sample-size
n=120
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Participant_Sample-size
n=120
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Participant_Age
children
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Participant_Condition
cancer
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Participant_Age
child
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Participant_Condition
cancer
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Participant_Age
Children
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Participant_Condition
cancer
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Participant_Age
child
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Participant_Condition
cancer
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Participant_Age
children
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Participant_Condition
cancer