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NCT Number: NCT05154305

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

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.

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Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, B-9000, Belgium

Location status: Recruiting

Location contact

Catharina Dhooghe, PHD

PRINCIPAL_INVESTIGATOR

Elise De Vos, MSc

CONTACT

[email protected]

00329/332.22.24

Hanne Capiau, MSc

CONTACT

[email protected]

00329/3320597

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multidisciplinary intervention

Behavioral
  • 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.

Primary outcomes

  1. Maximal exercise test

    Time frame: 20 minutes

    Maximal exercise test on a cycle ergometer

  2. Body composition

    Time frame: 5 minutes

    Body composition by dietitian

  3. Pediatric Quality of Life Inventory

    Time frame: 10 minutes

    assessment Quality of Life

  4. Children's Assessment of Participation and Enjoyment (CAPE)

    Time frame: 10 minutes

    assessment participation

  5. Preferences for Activities of Children (PAC)

    Time frame: 10 minutes

    assessment preferred activities

Study contacts

Contact information is provided by the study sponsor or research team.

Catharina Dhooge, MD, PhD

CONTACT

[email protected]

00329/3322452

Ruth Van Der Looven, MD

CONTACT

[email protected]

00329/332.69.39

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • VZW kinderkankerfonds, Belgium

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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