DOLORISK: Understanding Risk Factors and Determinants for Neuropathic Pain - Chronic Neuropathy Following Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Chemotherapy-induced Peripheral Neuropathy
研究概览
简要总结
This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination.
详细描述
This is a clinical study which is a follow-up of a previous prospective questionnaire study. All patients who previously participated in the study will receive a new questionnaire and will be invited for a clinical examination. This is a collaboration and part of the data will be combined with other data in this collaboration
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who have participated in a prospective questionnaire study
排除标准
- •Not able to visit in person.
结局指标
主要结局
Chemotherapy-induced Peripheral Neuropathy
时间窗: 5-year follow-up
For case definition of neuropathy, The Toronto classification (Tesfaye et al. 2010) will be used. Numbers indicate confirmed neuropathy.
Chemotherapy-induced Neuropathic Pain
时间窗: 5-year follow-up
Neuropathic pain grading system. Neuropathic pain was graded as "possible", "probable", or "definite" in accordance with the NeuPSIG grading system (Pascal M et al, Wellcome Open Research 2018).
次要结局
- Anxiety and Depression Using the Hospital Anxiety and Depression Scale (HADS).(5-year follow-up)
- Personality Using the International Personality Item Pool (IPIP).(5-year follow-up)
- Personality Using the 10-item Personality Inventory (TIPI).(5-year follow-up)
- Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Motor(5-year follow-up)
- Quality of Life Using EuroQol (EQ-5D).(5-year follow-up)
- Morphology of Small Fibers in Cornea After Chemotherapy by Corneal Confocal Microscopy (CCM).(5-year follow-up)
- Pain Descriptors by Douleur Neuropathique 4 (DN4).(5-Year follow-up)
- Pain Descriptors by Neuropathic Pain Symptom Inventory (NPSI).(5-Year follow-up)
- Neuropathy Using the Toronto Clinical Scoring System (TCSS).(5-year follow-up)
- Neuropathy Using the Michigan Neuropathy Screening Instrument (MNSI).(5-year follow-up)
- Sensory Abnormalities After Chemotherapy Assessed With Quantitative Sensory Testing (QST).(5-year follow-up)
- Fatigue Using the Patient Reported Outcomes Measurement Information System (PROMIS).(5-year follow-up)
- Pain Interference by Patient Reported Outcomes Measurement Information System (PROMIS).(5-year follow-up)
- Neuronal Excitability Changes After Chemotherapy Assessed With Threshold Tracking: Sensory(5-year follow-up)
- Anxiety and Depression Using the Patient Reported Outcomes Measurement Information System (PROMIS).(5-year follow-up)
- Pain Catastrophizing Using the Pain Catastrophizing Scale(PCS).(5-year follow-up)
- Blood Samples DNA(5-year follow-up)
- Neuropathy Using the Total Neuropathy Score.(5-year follow-up)