NCT02788565已完成不适用
SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin Analogues in Subjects With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Proportion of subjects with injection problems according to the subject
研究概览
简要总结
Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Such knowledge can be of importance in a treatment decision, decision support for development of care, follow up and training of both patients and primary care nurses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Signed informed consent
- •Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years
- •GEP-NET proliferation index Ki 67 <10%
- •Over 18 years of age
排除标准
- •No specific exclusion criteria defined
结局指标
主要结局
Proportion of subjects with injection problems according to the subject
时间窗: Day 1
Subject questionnaire asks "In your opinion, how did the last injection go?", subject chooses either 'no problems' or 'problems occurred'.
次要结局
- Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire.(Day 1)
- Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.(Day 1)
- Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual.(Day 1)
- Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.(Retrospective data collection of a 1 year period)
- Mean number of packs of H01CB03 and H01CB02 purchased.(Retrospective data collection of a 1 year period)
- Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.(Retrospective data collection of a 1 year period)
- Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel(Day 1)
- Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.(Day 1)
- Median number of packs of H01CB03 and H01CB02 purchased.(Retrospective data collection of a 1 year period)
- Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections(Day 1)
- Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire.(Day 1)
研究者
研究点 (2)
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