Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Sponsor
University Hospital, Ghent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05154305
Collaborator
VZW kinderkankerfonds, Belgium (Other)
60
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1
56
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Study Details

Study Description

Brief Summary

Recent numbers display a 85% survival-rate in children after a very harmful disease such as cancer. However, the survivors still experience mild to severe side effects of the primary disease or treatment.

A long time follow-up in the University Hospital of Ghent in children with cancer displays important long term side effects such as: reduced muscle strength; reduced endurance capacity; reduced exercise tolerance; fatigue; disturbed body composition with increased risk for obesity and/or diabetes and osteoporosis; and neuropathic damage and myopathy. These physical complaints have a significant impact on the activities and participation in daily living.

The purpose of this interventional study is to create a rehabilitation program for children after acute cancer treatment. The goal is to minimalize the previous described long term side effects of the disease. The current study should allow us to determine the effects of the intervention at the level of functioning, activities and participation. In addition, we account for the environment and personal factors as described by the International Classification of Functioning, disability and health (ICF-criteria).

The study population consists of children between 8 and 11 years and adolescents of 12 to 21 years old. All participants receive a multidisciplinary treatment for 4 months, guided by a team which includes: oncologist, rehabilitation doctor, physical therapist, dietitian, psychologist, and occupational therapist.

At the beginning of the multidisciplinary program, the participants receive psychoeducation, diet advice, tips for participation, fatigue, and psychological well-being. In general, the rehabilitation program focusses on reintegration at school and leisure activity.

After the first assessment, an individually adjusted physical program consisting of strength and endurance training will be made. This physical program will be executed 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis.

Participants will undergo assessment 3 times: 1) baseline (T0); 2) after 4 months treatment (T1); 3) after 1 year follow-up (T2).

The purpose of this program is to encourage patients at risk for increasing their healthy habits, exercise and participation in order to decrease long-term (side) effects.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: multidisciplinary intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment
Actual Study Start Date :
Apr 2, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Children 6 months post acute treatment

children and adolescents between 6 months and 8 years post acute cancer treatment

Behavioral: multidisciplinary intervention
individually adjusted physical program consisting of strength and endurance training > 3 times a week, 2 times guided by a physical therapist at the University Hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. Follow-up is foreseen on monthly basis. multidisciplinary coaching (discipline depending on personal needs of patient) on a monthly basis. These coaching sessions could be in small groups or individual.

Outcome Measures

Primary Outcome Measures

  1. Maximal exercise test [20 minutes]

    Maximal exercise test on a cycle ergometer

  2. Body composition [5 minutes]

    Body composition by dietitian

  3. Pediatric Quality of Life Inventory [10 minutes]

    assessment Quality of Life

  4. Children's Assessment of Participation and Enjoyment (CAPE) [10 minutes]

    assessment participation

  5. Preferences for Activities of Children (PAC) [10 minutes]

    assessment preferred activities

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • between 6 months and 8 years post acute cancer treatment

  • off medical treatment

  • all possible cancer diagnosis, except for brain tumors and sarcomas

Exclusion Criteria:
  • not able to participate for 3 consecutive weeks

  • not able to perform a maximal cardiopulmonary exercise test

  • unwilling to cooperate

  • relapse

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ghent University Hospital Ghent Belgium B-9000

Sponsors and Collaborators

  • University Hospital, Ghent
  • VZW kinderkankerfonds, Belgium

Investigators

  • Principal Investigator: Catharina Dhooghe, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05154305
Other Study ID Numbers:
  • 2018/0709
First Posted:
Dec 13, 2021
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Ghent

Study Results

No Results Posted as of Feb 24, 2022