Trial Information

Rehabilitation Including Social and Education in Children and Teenagers With Cancer

Background In Denmark 200 children under the age of 18 are diagnosed annually with cancer
and the prevalence of patients undergoing anticancer therapy is 300. The expected five-year
survival rate is 80%, but since the treatment is intensive with a high risk of
life-threatening infections, these patients are frequently isolated at home or in hospital
during their 1-2 years of therapy, which means reduced contact with their normal school
environment, leisure activities and friends. Long-term survivors of childhood cancer
frequently have compromised age-appropriate social relationships and psychosocial
development, difficulties with resuming physical activities, and poor self-esteem leading to
reduced quality of life. Intervention studies designed to improve physical and social
function during treatment of children with cancer are lacking.

Aim To develop an interactive rehabilitation programme that a) preserve the educational,
physical and psychosocial life of the patients or even obtains "growth with cancer", b)
maintains the child's everyday life (e.g. normal social relationships), and c) improves
long-term physical performance, social competences, higher grade educational enrollment, and
later integration into the labour market.

Theoretical basis This project is inspired by Erving Goffman's interactional theory on
normality and related concepts of stigma and frame analysis as well as Thomas Scheff's
theory on the concept of emotional and social bonds and the development of the sociology of
emotions.

Material and methods Intervention group: Children aged 6.0-18.0 years diagnosed with cancer
2013-2015 at Rigshospitalet (covers eastern part of Denmark (approximately 50% of total
population)).

Control group:

The primary control group is children with cancer treated at the university hospitals in
Odense, Aarhus and Aalborg 2013-2015.

In addition, outcome data for cases will be compared with three other (secondary)
comparative groups: a) children with cancer treated at any Danish childhood oncology unit
throughout Denmark in 2012 (historical controls); b) the sibling closest in age to the
intervention group patients (family matched); and c) the intervention group patient's
classmates.

Physical performance end point The physical performance will be monitored by: Andersen
interval test, Timed up and go test, Sit to stand test, flamingo balance test, strength of
hand by squeeze dynamometer and VO2 peak sub-max test.

Physical measures

Dexa scan

Questionnaires: PedsQL, Strength and Difficulties Questionnaire (SDQ), Revised Child anxiety
and Depression Scale, Resilience, Loneliness and Social Dissatisfaction Questionnaire og The
Children´s Impact of Event Scale 13.

Qualitative interviews: Qualitative interviews are performed with children with cancer,
their parents, and the ambassadors. The focus will be on sociometric status, social
independence and competences, self-esteem, fatigue, physical activity, educational outcome,
and safety issues as well as an evaluation of the intervention program.

Outcomes and statistical considerations Provided all children with cancer (6-18 years) are
included in the intervention or control group this study will be national cohort study
including approximately 120 intervention children and 120 control children during the three
year intervention period.

In relation to physical performance the power calculation is based on previous published
small studies that found a baseline VO2peak of 24.3 (SD5.9) among children with ALL. If 120
children are included in the intervention and in the control group, then it the study will
have a power or more than 0.85 to detect a 10% improvement and a power of 0.95 to detect a
15% improvement.