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
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.


CONCLUSIONS
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.


BACKGROUND
Clinical Trials.gov: file. NCT01772849 and NCT01772862.
Troels
T
Thorsteinsson
Anne Sofie
AS
Helms
Lis
L
Adamsen
Lars Bo
LB
Andersen
Karen Vitting
KV
Andersen
Karl Bang
KB
Christensen
Henrik
H
Hasle
Carsten
C
Heilmann
Nete
N
Hejgaard
Christoffer
C
Johansen
Marianne
M
Madsen
Svend Aage
SA
Madsen
Venka
V
Simovska
Birgit
B
Strange
Lone Friis
LF
Thing
Peder Skov
PS
Wehner
Kjeld
K
Schmiegelow
Department of Pediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark. hanne@baekgaard.com.
Hanne Baekgaard
HB
Larsen
D000293:Adolescent; D002648:Child; D002985:Clinical Protocols; D015444:Exercise; D006801:Humans; D009369:Neoplasms / Q000534:rehabilitation* / Q000628:therapy; D010353:Patient Education as Topic; D012944:Social Support; D011795:Surveys and Questionnaires