NCT05154305

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

Recruiting now NA Last updated 12 December 2023

What this trial tests

NA trial testing multidisciplinary intervention in Cancer Survivors in 60 participants. Currently enrolling.

Timeline

2 April 2019

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	2 April 2019
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Belgium

Drugs / interventions tested

• multidisciplinary intervention

Conditions studied

• Cancer Survivors — all drugs for Cancer Survivors →
• Rehabilitation — all drugs for Rehabilitation →
• Exercise Therapy — all drugs for Exercise Therapy →

Sponsor

University Hospital, Ghent

Who can join

Adults 8 to 21, any sex, with Cancer Survivors or Rehabilitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.