Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of the remote assessment and a digitally delivered exercise intervention
研究概览
简要总结
In this study, the investigators test whether it is possible to deliver an exercise intervention via video meetings to children and adolescents who have completed therapy for medulloblastoma. The exercise sessions will be individualized and offered three times weekly during 12 weeks.
详细描述
Tumors of the central nervous system (CNS) represent 25-30% of all cases of pediatric cancer in Sweden. The survival for children with a brain tumor has improved over the last years. The 5-year overall survival rate is now 70%, resulting in a growing number or survivors every year. Malignant brain tumors typically have a poor prognosis, and curative treatment usually requires a combination of neurosurgery, chemotherapy and/or radiotherapy. For the survivors, the cure often comes at the cost of long-term side effects. Finding effective ways to mitigate the long-term side effects after childhood brain tumor is important, since they can severely impact the survivors´ daily life.
There is growing evidence that physical exercise is beneficial to cognition and improves cardiorespiratory fitness and motor function. It appears to be important that interventions start early, within 1-2 years after radiotherapy. For this to be feasible in international multicenter trials, the intervention and outcome assessments will need to be delivered remotely. Whether this is feasible in children treated for medulloblastoma is not known.
The investigators will perform a pilot study to provide pivotal information on whether exercise training can be remotely delivered in the home environment in children treated for medulloblastoma. This will take exercise training from an interesting research concept into a scalable intervention that can be offered regardless of geographic location of the patient. The study will further define the validity and feasibility of in-home outcome assessments of cardiorespiratory, muscular fitness and motor function in children treated for medulloblastoma. If shown feasible, this will work as a proof-of-concept and lead the way for including physical activity intervention in other childhood cancer treatment protocols as well. The results from this study will also enable the researchers to proceed in the planning of the first exercise intervention to be included upfront in an international childhood cancer treatment protocol, the upcoming Pan-European treatment protocol for standard-risk medulloblastoma in children (SIOP-MB6).
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed therapy for medulloblastoma, including craniospinal radiation therapy, within 36 months before study entry.
排除标准
- •Inability to walk without support. Progressive disease.
结局指标
主要结局
Feasibility of the remote assessment and a digitally delivered exercise intervention
时间窗: From enrollment to the end of exercise at 12 weeks and then for prolonged support for another 12 weeks.
The researchers will test the feasibility of delivering the exercise intervention via video, defined as: 1. Adherence to the intervention by number of completed intervention sessions Acceptable level: ≥70% adherence at 6 months. 2. Data collection - feasibility of outcome measures Criteria: ≥ 90% of video-based measurements can be conducted according to protocol. ≥ 80% of PROM assessments can be completed as planned. 3. Safety Documentation of adverse events (all occurring and documented adverse events associated with the intervention will be recorded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.). 4. Acceptance and perceived usefulness Criterion: Qualitative analysis of interviews shows that the intervention is perceived as meaningful, feasible, and not too burdensome. 5. Technical aspects Criterion: ≥ 90% of participants can complete video sessions without major technical problems, beginning after the first three sessions.
次要结局
- Lower limb strength(Change from baseline until 3 and 12 months.)
- Physical activity(Change from baseline, until 1.5, 3, 6, and 12 months.)
- Handgrip strength(Change from baseline, until 3 and 12 months.)
- Patient-reported quality of life(Change from baseline, until 3 and 12 months.)
- Motor function(Change from baseline, until 3 and 12 months.)
- Cardiorespiratory fitness(Change from baseline, until 3 and 12 months.)
- Epigenetic age acceleration(Change from baseline, until 3 and 12 months.)
- Feasibility of the outcome measures(12 weeks)
- Cognitive function(Change from baseline to 12 weeks and 12 months.)
研究者
Aron Onerup
Principal investigator
Vastra Gotaland Region