NCT05289739已完成不适用
Get Strong to Fight Childhood Cancer: An Exercise Intervention for Children and Adolescents Undergoing Anti-Cancer Treatment
Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 478 人开始时间: 2022年4月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Change in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
研究概览
简要总结
The purpose of this multicenter study is to evaluate a personalised and standardised exercise intervention for children and adolescents undergoing anti-cancer treatment.
详细描述
In the randomised, controlled FORTEe trial, high evidence for an innovative, patient-centred exercise treatment shall be generated. Supervised exercise training intents to increase muscle strength and reduce muscular atrophy due to bedrest. CRF and HRQoL can be improved and in the future, these benefits may help to fight childhood cancer by increasing therapy efficiency and survival rate. Within the project, digital, innovative technologies such as augmented reality will be developed and applied to make the exercise training more effective, age-adapted and personalised. Moreover, FORTEe will stimulate translational research to provide access to paediatric exercise oncology as a new health care intervention. As a progress beyond the current state-of-the-art, FORTEe has the ambition to implement paediatric exercise oncology as an evidence-based standard in clinical care for all childhood cancer patients across the EU and beyond.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First/initial diagnosis of a primary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a relapsed oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy or First/initial diagnosis of a secondary oncologic disease according to the International Classification of Childhood Cancer (ICCC), requiring chemotherapy and/or radiation therapy
- •Planned or started anti-cancer treatment (chemo- and/or radiotherapy) at one of the recruiting centres of the FORTEe trial
- •The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as suitable to participate in the trial, e.g. due to medical or psychological reasons.
- •Existing informed consent (or assent) to participate in the study
- •The patient (and the legal guardian) has/have sufficient knowledge of the respective national or English language so that it is possible to carry out the informed consent as well as interviews (in age-appropriate language).
- •The patient is not in a terminal phase of the disease.
排除标准
- •Oncologic disease (primary/relapsed/secondary) according to the International Classification of Childhood Cancer (ICCC), requiring neither chemotherapy nor radiation therapy or solely requiring surgery
- •Reasons that already exist or are foreseeable at the time of study enrolment, due to which the patient will not have access to the exercise intervention and/or to the pre-test and/or to the post-test (e.g. foreseeable or planned, permanent change of treatment centre)
- •The patient is assessed by the treating team (pediatric oncologist, exercise professional etc.) as unsuitable to participate in the trial, e.g. due to medical or psychological reasons.
- •After detailed information and, if necessary, having time to consider, the patient (≥ 16 years of age) did not agree to give written informed consent to participate in the trial.
- •The patient (and the legal guardians) has/have insufficient knowledge of the respective national or English language, so that it is not possible to carry out both the informed consent and interviews (in age-appropriate language).
- •The patient is in a terminal phase of the disease
研究组 & 干预措施
Exercise group
Experimental
Usual medical care + supervised exercise training during intensive medical treatment
干预措施: Exercise training (Behavioral)
Control group
No Intervention
Usual medical care
结局指标
主要结局
Change in the score of Cancer-related fatigue during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline
时间窗: pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention
Cancer-related fatigue measured by the Pediatric Quality of Life Inventory (PedsQL) 3.0 Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale is composed of 18 items comprising three dimensions. Scores are transformed on a scale from 0 to 100. Higher scores indicate lower fatigue.
次要结局
- Longitudinal assessment of oxidative skeletal muscle impairment after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in hamstrings flexibility after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in functional mobility after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in endurance performance (measured by the assisted 6-minute cycling test) after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in body composition (measured via skinfold measurement) after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in the Physical activity level (measured by the Modified Children's Physical Activity Questionnaire (mCPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the Physical activity level and behaviour during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in functional capacity after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in the score of general Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of cancer-related Health-Related Quality of Life during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of Resilience (measured by Mainzer Resilience Scale for childhood cancer (MRScc)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of Resilience (measured by the Child & Youth Resilience Measure-Revised (CYRM-R)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of General self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of Physical exercise self-efficacy during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in lower limbs flexibility after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in the score of Mental Health (measured by WHO (Five) Well-Being Index) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of Mental Health (measured by Warwick-Edinburgh Mental Well-being Scale (WEMWBS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the score of Resilience (measured by the Brief Resilience Scale (BRS)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in peak oxygen uptake (VO2peak) after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in functional strength after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in arm strength after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in upper body strength after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in leg extension strength after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in the Physical activity level (measured by the Modifed Recent Physical Activity Questionnaire (mRPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in the Physical activity level (measured by the Modified Youth Physical Activity Questionnaire (mYPAQ)) during the intervention, after the intervention, and over a 1-year follow-up period compared with baseline(pre-intervention; bi-weekly during the intervention (up to 10 weeks); end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention; after intensive cancer treatment; 15 months after the end of intervention)
- Change in endurance performance (measured by the adapted Yo-Yo-Test) after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in motor function after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in knee flexor strength after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change of the phase angle by means of bioelectrical impedance analysis for the examination of body composition after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Change in body composition (measured via dual-energy x-ray absorptiometry) after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Usability of the augmented reality app(post app use (15 months after the end of intervention))
- Change in the number of T-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
- Change in the number of NK-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
- Change in the DNA methylation status of NK cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
- Usability of the pixformance station(post app use (15 months after the end of intervention))
- Change in the number of B-cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
- Change in the number of leukocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
- Change in the DNA methylation status of T cells before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
- Change in static balance after the intervention and after a 12-week follow-up compared to baseline(pre-intervention; end of intervention (assessed up to 10 weeks); 12 weeks after the end of intervention)
- Composite multidimensional socioeconomic status index(pre-intervention)
- Usage frequency of the augmented reality (AR) app from baseline to the end of app use(during the use of the app from baseline until the end of app use (15 months after the end of intervention))
- Change in the number of monocytes before start of anti-cancer treatment (baseline), pre-exercise intervention and post-exercise intervention(Blood sampling before start of anti-cancer treatment (chemo- and/or radiotherapy); pre-intervention; end of intervention (assessed up to 10 weeks))
研究者
Joerg Faber
Univ. Prof. Dr. med.
Johannes Gutenberg University Mainz
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Fit to Fight Childhood CancerPediatric OncologyNCT05867186Johannes Gutenberg University Mainz100
招募中
不适用
Exercise Training in Children With Communication ImpairmentsDevelopmental Language DisorderNCT06340893Marquette University40
进行中（未招募）
不适用
Physically Active During Cancer Treatment (FAKT)Neoplasms, ColorectalNCT03885817St. Olavs Hospital66
招募中
不适用
Strength After Breast CancerBreast CancerNCT06052488MGH Institute of Health Professions40
已完成
不适用
Physical Activity in Pediatric Cancer (PAPEC)Pediatric CancerNCT01645436Universidad Europea de Madrid49