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

Childhood Cancer Clinical Trial

— RESPECT  

Official title:

Rehabilitation Including Social and Education in Children and Teenagers With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01772862
• Other study ID #: RESPECT - physical activity
• Secondary ID: H-3-2012-105
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2013
• Last updated: February 6, 2013
• Start date: January 2013
• Est. completion date: January 2019

Study information

• Verified date: February 2013
• Source: Rigshospitalet, Denmark
• Contact: Kjeld Schmiegelow, M.D
• Phone: 0045 35451357
• Email: kjeld.schmiegelow[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Behavioral:
• 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". An individualized physical training program combining supervised and non-supervised training 3-5 times per week. Continued specialized physical training when relevant. At two weeks intervals joined education, physical and social activity days at the hospital with together with one of the ambassadors

Locations

Country	Name	City	State
Denmark	Kjeld Schmiegelow	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Kjeld Schmiegelow	Aalborg Universitetshospital, Aarhus University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of VO2 max	We hypothesize that the children in the intervention group receiving a individualized physical training program three time a week during the intensive treatment period with surgery, irradiation or chemotherapy treatments will have a 10% higher VO2max level than children with cancer in the control group who do not receive such training	1 year after cessation of first-line cancer treatment	No
Secondary	Health quality of life	Quality of life is assessed by questionnaires, and qualitative interviews	Diagnosis, 6 months after diagnoses, 1 year post treatment	No