Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer
NCT ID: NCT01772849
Last Updated: 2013-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2013-01-31
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
Standard educational programme
The children receive the standard of care with respect to education this include education in the hospitals school or at home without a class mate and no specific activity to secure continuous linkage with community school and class mates
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
6 Years
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Kjeld Schmiegelow
OTHER
Responsible Party
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Kjeld Schmiegelow
Professor
Principal Investigators
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Kjeld Schmiegelow, M.D
Role: STUDY_DIRECTOR
University Hospital of Copenhagen, Rigshospitalet
Locations
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Kjeld Schmiegelow
Copenhagen, , Denmark
Kjeld Schmiegelow
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Nielsen MKF, Christensen JF, Frandsen TL, Thorsteinsson T, Andersen LB, Christensen KB, Wehner PS, Hasle H, Adamsen LO, Schmiegelow K, Larsen HB. Effects of a physical activity program from diagnosis on cardiorespiratory fitness in children with cancer: a national non-randomized controlled trial. BMC Med. 2020 Jul 6;18(1):175. doi: 10.1186/s12916-020-01634-6.
Lindgren LH, Schmiegelow K, Helms AS, Thorsteinsson T, Larsen HB. In sickness and in health: classmates are highly motivated to provide in-hospital support during childhood cancer therapy. Psychooncology. 2017 Jan;26(1):37-43. doi: 10.1002/pon.4094. Epub 2016 Feb 12.
Thorsteinsson T, Helms AS, Adamsen L, Andersen LB, Andersen KV, Christensen KB, Hasle H, Heilmann C, Hejgaard N, Johansen C, Madsen M, Madsen SA, Simovska V, Strange B, Thing LF, Wehner PS, Schmiegelow K, Larsen HB. Study protocol: Rehabilitation including Social and Physical activity and Education in Children and Teenagers with Cancer (RESPECT). BMC Cancer. 2013 Nov 14;13:544. doi: 10.1186/1471-2407-13-544.
Other Identifiers
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H-3-2012-105
Identifier Type: OTHER
Identifier Source: secondary_id
RESPECT - education
Identifier Type: -
Identifier Source: org_study_id
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