Rehabilitation Including Social and Physical Activity in Children and Teenagers With Cancer (RESPECT)

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:
NCT01772862
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 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


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 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 VO2 max [ Time Frame: 1 year after cessation of first-line cancer treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Health 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
No Intervention: Only conventional supportive care
The children receive conventional supportive care with respect to physical training
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". 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

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

Other Name: Integrated physical training

  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: NCT01772862

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

Locations
Denmark
Kjeld Schmiegelow Recruiting
Copenhagen, Denmark, 2100
Contact: Kejld Schmiegelow, MD    +4535451357    kjeld.schmiegelow@regionh.dk   
Contact: hanne Larsen, post.doc    +4535459647      
Sub-Investigator: hanne Larsen, post.doc         
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: NCT01772862     History of Changes
Other Study ID Numbers: RESPECT - physical activity, 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
physical activity
quality of life

ClinicalTrials.gov processed this record on August 28, 2014