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临床试验/NCT05154305
NCT05154305招募中不适用

Multidisciplinary Rehabilitation of Children and Adolescents After Acute Cancer Treatment

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Preferences for Activities of Children (PAC)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
8 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • between 6 months and 8 years post acute cancer treatment
  • off medical treatment
  • all possible cancer diagnosis, except for brain tumors and sarcomas

排除标准

  • not able to participate for 3 consecutive weeks
  • not able to perform a maximal cardiopulmonary exercise test
  • unwilling to cooperate

结局指标

主要结局

Preferences for Activities of Children (PAC)

时间窗: 10 minutes

assessment preferred activities

Maximal exercise test

时间窗: 20 minutes

Maximal exercise test on a cycle ergometer

Children's Assessment of Participation and Enjoyment (CAPE)

时间窗: 10 minutes

assessment participation

Body composition

时间窗: 5 minutes

Body composition by dietitian

Pediatric Quality of Life Inventory

时间窗: 10 minutes

assessment Quality of Life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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