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Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer (RESPECT-EDU)

This study is currently recruiting participants.
Verified February 2013 by Kjeld Schmiegelow, Rigshospitalet, Denmark
Sponsor:
ClinicalTrials.gov Identifier:
NCT01772849
First Posted: January 21, 2013
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Odense University Hospital
Aarhus University Hospital
Aalborg Universitetshospital
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention
Childhood Cancer Behavioral: Intervention group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Rehabilitation Including Social Activity and Education in Children and Teenagers With Cancer

Resource links provided by NLM:


Further study details as provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Level of educational achievement [ Time Frame: 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:
  • Quality of life [ Time Frame: diagnosis, 6 months after diagnoses, 1 year post treatment ]
    Quality of life is assessed by questionnaires, and qualitative interviews


Estimated Enrollment: 240
Study Start Date: January 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

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" 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 Name: Integrated education acitivity
No Intervention: 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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772849


Contacts
Contact: Kjeld Schmiegelow, M.D 0045 35451357 kjeld.schmiegelow@regionh.dk
Contact: Hanne B Larsen, MS Sociology 0045 35459647 hanne@baekgaard.com

Locations
Denmark
Kjeld Schmiegelow Recruiting
Copenhagen, Denmark, 2100
Contact: Kjeld Schmiegelow, M.D    004535451357    kjeld.schmiegelow@regionh.dk   
Contact: Hanne B Larsen, MS Sociology    0045 35459647    hanne@baekgaard.com   
Principal Investigator: Kjeld Schmiegelow, M.D         
Kjeld Schmiegelow Recruiting
Copenhagen, Denmark, 2100
Contact: Kjeld Schmiegelow, M.D    004535451357    kjeld.schmiegelow@regionh.dk   
Contact: Hanne Larsen, MS sociology    004535459647    hanne@baekgaard.com   
Principal Investigator: Kjeld Schmiegelow, M.D         
Sponsors and Collaborators
Kjeld Schmiegelow
Odense University Hospital
Aarhus University Hospital
Aalborg Universitetshospital
Investigators
Study Director: Kjeld Schmiegelow, M.D University Hospital of Copenhagen, Rigshospitalet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01772849     History of Changes
Other Study ID Numbers: RESPECT - education
H-3-2012-105 ( Other Identifier: Ethical Review Board of Region Hovedstaden )
First Submitted: January 11, 2013
First Posted: January 21, 2013
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:
childhood
cancer
education
physical activity
quality of life