Assessing Impact of Surgically-induced Deficits on Patient Functioning and Quality of Life (SIND Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Impact of new deficit on quality of life
研究概览
简要总结
This study provides a work package for a larger programme of research developing Precision Surgery for Glioblastomas by developing individualised treatment volumes for surgery and radiotherapy. This study will recruit a cohort of patients with tumours in different brain regions and involve imaging pre- and post-operatively to outline the area of 'injury' to normal brain. The investigators will then correlate anatomical disruption with changes in measures of quality of life, visual functioning and visual fields and neuropsychology.
详细描述
This study aims to explore the effect of surgically induced visual and neuro-cognitive defects on patient functioning and quality of life. The aims of this study are:
- Understand the impact of surgically induced lesions of visual and limbic pathways on quality of life;
- Determine anatomical regions and brain networks that lead to deterioration in quality of life;
- Determine extent of early recovery from surgically-induced lesions.
Patient Assessment: Patients will be assessed using the following tools.
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Ophthalmological assessment - will include:
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Acuity (LogMAR - Logarithm of the Minimum Angle of Resolution);
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Colour vision (Ishihara);
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Basic eye exam to exclude pre-existing ocular pathology (e.g. papilloedema causing a constricted field/enlarged blind spot);
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Monocular (Humphrey) and binocular (Esterman) visual field tests.
-
MR imaging - imaging protocol will include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent to participate
- •Assessed by a neuroscience multi disciplinary team meeting (MDT) to have a high grade glioma on imaging;
- •World Health Organisation Performance Scale (WHO PS 0 or 1);
- •Patient suitable for tumour resection where the treating neurosurgeon feels that >90% of the enhancing tumour will be resected.
排除标准
- •Pre-existing complete homonymous hemianopia or unilateral blindness or visual problems leading to patient being certified sight impaired (visual acuity of 3/60 to 6/60 with a full field of vision or visual acuity of up to 6/24 with a moderate reduction of field of vision or with a central part of vision that is cloudy or blurry).
- •Pre-existing severe psychiatric disease
- •Patients who are unsuitable for a contrast-enhanced MRI will be excluded.
- •Such clinical problems include, but are not limited to:
- •MR unsafe metallic implants;
- •Claustrophobia;
- •Allergy to gadolinium contrast agent;
- •History of severe renal impairment.
结局指标
主要结局
Impact of new deficit on quality of life
时间窗: 5 +/- 1 weeks post surgery (delayed assessment as defined above)
Comparison of quality of life measures (using EORTC QLQ30 with BN20 module scores) for patients with and without newly developed surgically induced deficits. These are standard tools for assessing patient reported quality of life
次要结局
- Recovery of visual deficits(5 +/- 1 weeks post surgery (delayed assessment as defined above))
- Recovery of cognitive deficits using OCS-Bridge tool(Within 72 hours of surgery (early assessment as defined above))
- Impact of deficits on overall survival(Developing a deficit/not developing deficit will be classified at 6 weeks of surgery (pre-RT). Overall survival figures will be followed until the death of the patient or six months from the last patient undergoing their post-RT assessment.)
- Anatomical disruption(Within 72 hours of surgery (early assessment as defined above))
- Quantifying white matter tract disruption(5 +/- 1 weeks post surgery (delayed assessment as defined above))
研究者
Stephen J Price
NIHR Career Development Fellow and Hon. Consultant Neurosurgeon
Cambridge University Hospitals NHS Foundation Trust