NCT03450876已完成不适用
A Prospective Multicenter Cohort Study of Late Physical Psychological and Social Effects in Patients Treated With Ipilimumab for Advanced Melanoma
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2016年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)
研究概览
简要总结
Study of late physical, psychological and social effects in patients treated with ipilimumab for advanced (stage IV or unresectable stage III) melanoma.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ C30)
时间窗: Baseline up to 3 years
EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Baseline up to 3 years)
- Multidimensional Fatigue Inventory (MFI)(Baseline up to 3 years)
- Cancer Worry Scale (CWS)(Baseline up to 3 years)
- Impact of Cancer Questionnaire (IOCv2)(Baseline up to 3 years)
- EuroQOL-5D (EQ-5D) survivors(Baseline up to 3 years)
- European Organisation for Research and Treatment of Cancer Quality Of Life (EORTC QLQ) module for sexual health(Baseline up to 3 years)
- Work Ability Index questionnaire (WAI)(Baseline up to 3 years)
- EORTC information module (EORTC QLQINFO25)(Baseline up to 3 years)
- Functional Assessment of Cancer Therapy-Melanoma questionnaire (FACT-M)(Baseline up to 3 years)
研究者
研究点 (1)
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