Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.
详细描述
Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL, function and cognition is of major clinical importance in this population. Because the majority of patients cannot be cured, clinical cancer research traditionally have focused on prolonging survival, exposing relapse or optimising the response to the medical treatment. Today there is a general consensus that health-related quality of life (HRQoL) is important in the evaluation of new treatments. However, research in HRQoL among patients with gliomas is scarce compared to the other categories of patients with tumors. In recent years have exercise become an important part of cancer treatment. The effects is well documented in studies among other cancer patients than gliomas and includes improvements of quality of life, physical function, reduce fatigue and thereby supports daily activities among cancer patients'. Inpatient rehabilitation studies among glioma patients have also indicated improved HRQoL and functional measurements such as activity of daily life, mobility and cognition. Despite of this rehabilitation efforts is still not emphasized in this population and recent literature concludes that there are no well-designed clinical studies examining the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first to investigate the effect of an intensive specialised interdisciplinary outpatient rehabilitation program among gliomas patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary glioma (WHO grades I-IV)
- •Reference with diagnosis or treatment at Odense University Hospital
- •Karnofsky performance score (KPS) ≥70
- •Ability to understand Danish.
排除标准
- •Pregnancy
- •Known psychiatric diagnosis or substance abuse
- •Heart problems excluding intense exercise (NYHA group III and IV)
- •Pronounced impressive/expressive aphasia
研究组 & 干预措施
Interdisciplinary rehabilitation
The intervention consists of 6 weeks intensive outpatient physiotherapy in conjunction with 0-6 weeks of occupational therapy if need is indicated. The physical intervention contains supervised group exercise of 90 minutes three times a week in groups up to four patients included continuously.
The occupational therapy intervention consists of individual training 60 minutes twice a week for patients having deficits in activity or participation levels measured by the Assessment of Motor and Process Skills (AMPS).
干预措施: Interdisciplinary rehabilitation (Behavioral)
Care as usual
The control group receives usual standard of care (e.g. no training, individual training or group training in the municipality). The amount of training in this group is based on a questionnaire at the follow-up trials.
结局指标
主要结局
Health related quality of life
时间窗: Change from Baseline HRQoL at 6 months
Questionnaires EORTC-QLQ-30 \& BN-20
次要结局
- Physical activity levels(Change from Baseline Physical activity levels at 6 months)
- Muscle strength(Change from Baseline Musclestrength at 3 months)
- VO2peak(Change from Baseline VO2peak at 3 months)
- Balance(Change from Baseline Balance at 3 months)
- Gait function(Change from Baseline gait function at 3 months)
- Activity levels(Change from Baseline Activity levels at 3 months)
- Symptom burden(Change from Baseline Symptom burden at 6 months)
研究者
Anders Hansen
Physiotherapist, Master of Health Science
Odense University Hospital