Rehabilitation Including Social and Physical Activity in Children and Teenagers With Cancer
NCT ID: NCT01772862
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
240 participants
INTERVENTIONAL
2013-01-31
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rehabilitation Including Structured Active Play for Preschoolers With Cancer.
NCT04672681
Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.
NCT02284061
Social and Physical Activity as Rehabilitation for Preschool Kids With Cancer
NCT07213024
Effectiveness of an Integrated Programme in Promoting the Regular Physical Activity Among Childhood Cancer Survivors
NCT01803672
Group Intervention to Increase Physical Activity in Childhood Cancer Survivors
NCT01835509
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Only conventional supportive care
The children receive conventional supportive care with respect to physical training
No interventions assigned to this 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". 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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Kjeld Schmiegelow
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kjeld Schmiegelow
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kjeld Schmiegelow, M.D
Role: STUDY_DIRECTOR
University Hospital of Copenhagen, Rigshospitalet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kjeld Schmiegelow
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
hanne Larsen, post.doc
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
Nielsen MKF, Christensen JF, Frandsen TL, Thorsteinsson T, Andersen LB, Christensen KB, Nersting J, Faber M, Schmiegelow K, Larsen HB. Testing physical function in children undergoing intense cancer treatment-a RESPECT feasibility study. Pediatr Blood Cancer. 2018 Aug;65(8):e27100. doi: 10.1002/pbc.27100. Epub 2018 May 9.
Thorsteinsson T, Larsen HB, Schmiegelow K, Thing LF, Krustrup P, Pedersen MT, Christensen KB, Mogensen PR, Helms AS, Andersen LB. Cardiorespiratory fitness and physical function in children with cancer from diagnosis throughout treatment. BMJ Open Sport Exerc Med. 2017 May 12;3(1):e000179. doi: 10.1136/bmjsem-2016-000179. eCollection 2017.
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
Review additional registry numbers or institutional identifiers associated with this trial.
H-3-2012-105
Identifier Type: OTHER
Identifier Source: secondary_id
RESPECT - physical activity
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.