NCT01772849

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

6 years

First QC Date

January 11, 2013

Last Update Submit

February 6, 2013

Conditions

Childhood Cancer

Keywords

childhoodcancereducationphysical activityquality of life

Outcome Measures

Primary Outcomes (1)

  • Level of educational achievement

    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.

    1 year after cessation of first-line cancer treatment

Secondary Outcomes (1)

  • Quality of life

    diagnosis, 6 months after diagnoses, 1 year post treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Standard educational programme

NO INTERVENTION

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

Interventions

Intervention groupBEHAVIORAL

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

Also known as: Integrated education acitivity
Intervention group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Mental retardation at the time of diagnosis (including Down syndrome). Terminal illness at the time of diagnoses. Severe co-morbidity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kjeld Schmiegelow

Copenhagen, 2100, Denmark

RECRUITING

Kjeld Schmiegelow

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32624004DERIVED

  • 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.

    PMID: 26872002DERIVED

  • 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.

    PMID: 24229362DERIVED

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kjeld Schmiegelow, M.D

    University Hospital of Copenhagen, Rigshospitalet

    STUDY DIRECTOR

Central Study Contacts

Kjeld Schmiegelow, M.D

CONTACT

0045 35451357kjeld.schmiegelow@regionh.dk

Hanne B Larsen, MS Sociology

CONTACT

0045 35459647hanne@baekgaard.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 21, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

DK(2)