Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer

Not Applicable

• Conditions: Childhood Cancer
• Interventions: Behavioral: Intervention group

• Registration Number: NCT01772849
• Lead Sponsor: Kjeld Schmiegelow

Brief Summary

The purpose of this study is to determine whether early rehabilitation intervention including educational and social activities with a class mate at two weeks intervals at the ped.onc. center will increase children with cancer's level of education performance.

Detailed Description

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.

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.

If the children´s academic performance are divided into five categories (unsatisfactory to outstanding level of performance) with a distribution of performance on the five categories as 10 %; 20 %; 40 %; 20 %; 10 % and where a change from one category to another are regarded as a significant change in the child´s academic performance, it is possible to achieve a strength over 0.90 to detect a change of the average by 0.5 if 120 children are included.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Children diagnosed with cancer and treated at the pediatric oncology units in Denmark (Rigshospitalet, Odense University hospital, Aarhus University Hospital and Aalborg University Hospital)

Children diagnosed with non-malignant diseases treated with surgery, chemotherapy or irradiation similar to cancer (e.g. benign CNS tumors, langerhans cell histiocytosis, Myelodysplastic Syndrome (MDS)) and treated at the pediatric oncology units in Denmark (Rigshospitalet, Odense University hospital, Aarhus University hospital and Aalborg University Hospital).

Attend school at the time of diagnosis

Able to communicate in Danish

Exclusion Criteria

• Mental retardation at the time of diagnosis (including Down syndrome). Terminal illness at the time of diagnoses. Severe co-morbidity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention group	The intervention components includes (real time sequence): An educational session where the child is educated on his/her cancer disease An education session in the child's school where the child´s teachers, classmates and their parents are educated on the child´s cancer disease. Appointment of two classmates as "ambassadors" Continued individualized education at the hospital school or at home that parallels/copies the educational curriculum in the child regular school At two weks intervals joined education, physical (separate study) and social activity days at the hospital with together with one of the ambassadors

Primary Outcome Measures

Name	Time	Method
Level of educational achievement	1 year after cessation of first-line cancer treatment	The child´s level of education in Danish (1. language and reading) and math is measured on a five point scale including outstanding level of performance, high level of performance, satisfactory level of performance, needs improvement in level of performance, and unsatisfactory level of performance. Maximum 10% of the children in the intervention group receiving the integrated education program with their regular class mate's will experience a decrease of one or more levels on the five point performance scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life	diagnosis, 6 months after diagnoses, 1 year post treatment	Quality of life is assessed by questionnaires, and qualitative interviews

Trial Locations

Locations (1)

Kjeld Schmiegelow; 🇩🇰 Copenhagen, Denmark