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Open Access Study protocol

Study protocol: rehabilitation including social and physical activity and education in children and teenagers with cancer (RESPECT)

Troels Thorsteinsson1, Anne Sofie Helms12, Lis Adamsen3, Lars Bo Andersen4, Karen Vitting Andersen1, Karl Bang Christensen5, Henrik Hasle6, Carsten Heilmann1, Nete Hejgaard17, Christoffer Johansen89, Marianne Madsen1, Svend Aage Madsen1, Venka Simovska10, Birgit Strange11, Lone Friis Thing12, Peder Skov Wehner13, Kjeld Schmiegelow12 and Hanne Baekgaard Larsen1*

Author Affiliations

1 Department of Pediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

2 Faculty of Health Sciences, The University of Copenhagen, Blegdamsvej 2b, 2100 Copenhagen, Denmark

3 Department of Public Health and Faculty of Health Sciences, The University Hospitals Centre for Nursing and Care Research (UCSF), Copenhagen University Hospital Rigshospitalet, Ryesgade 27, 2200 Copenhagen, Denmark

4 Institute for Sport Sciences and Clinical Biomechanics, The University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark

5 Department of Biostatistics, The University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, , 1014 Copenhagen, Denmark

6 Department of Pediatrics, Aarhus University Hospital, Skejby, Brendstrupgårdsvej 100, 8200 arhus N, Denmark

7 Øster Farimagsgade Skole, Øster Farimagsgade 41, 2100 Copenhagen Ø, Denmark

8 Department of Oncology, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark

9 Head Survivorship Department, The Danish Cancer Society Research Center, Strandboulevarden 49, 2100 Copenhagen, Denmark

10 Department of Education, Aarhus University, Campus Emdrup, Tuborgvej 164, 2400 Copenhagen, Denmark

11 Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

12 Department of Nutrition, Exercise and Sports, The University of Copenhagen, Nørre Allé 51-55, 2200 Copenhagen N, Denmark

13 Department of Pediatric Hematology and Oncology, The H. C. Andersen Children’s Hospital, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Denmark

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BMC Cancer 2013, 13:544  doi:10.1186/1471-2407-13-544

Published: 14 November 2013

Abstract

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

Keywords:
Cancer; Pediatric; Children; Rehabilitation; Physical activity; Quality of life; Intervention; Peers; Controlled; School reentry