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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Odense University Hospital
Aarhus University Hospital
Aalborg Universityhospital
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01772849
First received: January 11, 2013
Last updated: February 6, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Level of educational achievement [ Time Frame: 1 year after cessation of first-line cancer treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Universityhospital
Investigators
Study Director: Kjeld Schmiegelow, M.D University Hospital of Copenhagen, Rigshospitalet
  More Information

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: January 11, 2013
Last Updated: February 6, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on August 26, 2014