NCT05154305 Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment
| NCT ID | NCT05154305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Cancer Survivors |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-04-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2019-04-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Catharina Dhooghe, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05154305 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 21 Years, studying Cancer Survivors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05154305 currently recruiting?
Yes, NCT05154305 is actively recruiting participants. Contact the research team at CATHARINA.DHOOGE@UZGENT.BE for enrollment information.
Where is the NCT05154305 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT05154305 clinical trial?
NCT05154305 is sponsored by University Hospital, Ghent. The principal investigator is Catharina Dhooghe, MD, PhD at University Hospital, Ghent. The trial plans to enroll 60 participants.
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